Your Federal Quarterly Tax Payments are due April 15th Get Help Now >>

Hvac Frs Template - PDF by zat13158

VIEWS: 112 PAGES: 16

Hvac Frs Template document sample

More Info
									                   Puerto Rico’s Largest and Most Comprehensive Validation Event!



       Validation Workshop Series
       June 21 - 23, 2006 • San Juan, Puerto Rico • El San Juan Hotel & Casino

   Hear from Validation Experts from 21 Pharmaceutical, Biotechnology,
   Manufacturing and Allied Companies…
   • AAC Group                    • Institute of Validation     • Paciv, Inc.
   • Abbott Laboratories            Technology                  • Quintiles Consulting
   • Arion Water, Inc.            • IPR Pharmaceuticals         • Roche Diagnostics
   • AstraZeneca                  • MannKind                      Corporation
   • Boston Scientific              BioPharmaceuticals          • STERIS Corporation
   • Deloitte & Touche LLP        • McNeil Consumer             • Watson
                                    Healthcare                    Pharmaceuticals
   • Diosynth Biotechnology RTP
                                  • Merck & Co., Inc.           • Wyeth, Inc.
   • Eli Lilly and Company
                                  • Monarch Quality Systems
   • ISS Corporation
                                    Solutions
                                                                             RE
                                                                      R BEFO
                                                              REGISTE
                                                                       5, 2006
                                                                APRIL 2
                                                                      !
                                                               AVE 10%
   Featured Topics Include:                                                                       CREATE-
   • Introduction to Risk Based Computer                      S                                YOUR-OWN
     System Validation                                                                       CONFERENCE:
   • Cleaning Validation                                                                     CHOOSE FROM
                                               • Statistics in Validation
   • Validation Training – How Do I Do It?
   • FDA’s System Based Inspections of
     Production and Process Control
                                               • Reducing Validation Efforts
                                                 Through Commissioning
                                               • Validation Master Planning
                                                                                                   35
                                                                                              INTERACTIVE

   • Analytical Instrument Qualification                                                     WORKSHOPS,
                                               • Harmonization of Global CSV                   EXPANDED
   • Auditing Validation Programs                Regulatory Requirements
                                                                                                SESSIONS,
   • Equipment Validation                      • Deviation Reduction                         AND GENERAL
   • Deviation Reduction for Validation        …. Plus many more!                               SESSIONS




SUPPORTING PUBLICATIONS

                                                                                         ®
                                      Validation Workshops • Wednesday, June 21, 2006
                                             Pre-Conference Half-Day Workshops

7:30 AM – Conference Registration and
                                                                                              Workshop B 8:30 AM – 12:00 PM
Continental Breakfast
                                                                                    Introduction to Risk Based Computer System
                                                                                    Validation
         Workshop A 8:30 AM – 12:00 PM                                              Sharon Strause, Industry Consultant, formerly Senior IM Consultant, SAP
Process Validation: an Implementation Roadmap                                       Manager, McNeil Consumer Healthcare, a J&J Company; Mark Kropp,
Faris E.Yany, Ph.D., Project Director, Division of Validation and                   MD Manager, MannKind Biopharmaceuticals
Regulatory Compliance Services, ISS Corporation
                                                                                    I. Defining Computer System Validation (CSV) and
I. Traditional Process Validation: The Old Paradigm                                    System Development Lifecycle (SDLC)
    • Losing sight of the goal                                                           • CSV and SDLC terminology
    • Validating without understanding                                                   • IQ/OQ/PQ
    • Disincentives and fear                                                             • CSV in relation to the SDLC
    • The “Rule of Three”
    • Regulatory constraints                                                        II. Regulatory Focus for Systems Validation
                                                                                         • Regulatory requirements of CSV
II. Process Validation for the 21st Century:                                             • FDA’s new Part 11 Guidance and how to use it
    The New Paradigm                                                                     • FDA’s new risk-based approach
    • Change is in the air
    • Different approaches                                                          III. Developing a Validation Strategy
    • Different goals                                                                    • Essential procedures and documentation to have in place
    • Investing in process development                                                   • Validation Master planning
                                                                                         • Test protocols and scripts
III. Defining Requirements
    • Equipment design and specifications                                           IV. Risk Assessment and Risk Management
    • Control Points                                                                     • Risk defined
    • Specifications                                                                     • Risk management structure and definitions
    • Process mapping                                                                    • Risk documentation
    • The PV team
                                                                                    V. Risk Management for Computer Systems and
IV. Gathering the Right Information                                                    Network Infrastructure
    • Go beyond the development report                                                   • Identifying network infrastructure risks
    • Take your time to understand the process and the product                           • Assessing infrastructure risks
    • Question R&D
    • Establish process parameters vs. product specifications rela-                 VI. Interactive Exercise
      tionships                                                                          A number of interactive exercises will be used in the session to
    • Developing the right protocol                                                      teach the principles presented.

V. Interactive Exercise
    A comparative exercise of traditional process validation
    approach vs. the scientific end engineering knowledge based
    approach to process validation.




    SPEAKING OPPORTUNITIES
    Are you interested in speaking at one of our
    upcoming conferences?
    We are continuously searching for industry experts to speak at conferences in the
    U.S. and Europe. Besides sharing your expertise with the audience, you will also receive
    complimentary access to the entire event.
    For more information please contact: Gregory Kiner • IVT Conference Producer • 954.567.9402 • gkiner@advanstar.com


          Institute of Validation Technology                        w w w. i v t h o m e. co m                                        218-723-9130
                                                                                2
                                                   Wednesday, June 21, 2006
                                              Pre-Conference Half-Day Workshops

         Workshop C 8:30 AM – 12:00 PM                                                  Workshop D 8:30 AM – 12:00 PM
Introduction to Cleaning Validation                                           Strategies for Effective Design and Qualification of
Rebecca Buede, Central Quality Validation Consultant, Roche                   Pharmaceutical Facility and Utility Systems
Diagnostic Corporation                                                        Miguel Montalvo,Vice President,Validation Compliance, AAC
                                                                              Consulting Group, Inc.
I. Overview of Cleaning Process Lifecycle
    • Cleaning process lifecycle model                                        I. Why Do We Need to Qualify These Systems?
    • Activities and deliverables produced at each stage                           • Regulatory References
    • Cycle interfaces, inputs, and outputs                                        • Impact of ISO 14644 Series Documents on HVAC Systems
                                                                                   • Applicable ICH Guidelines and efforts
II. Introduction to Cleaning Process Validation                                    • General facilities requirements
    Program Elements
    • Description and hierarchy of program deliverables                       II. Plant Utilities and “Process Support” Systems
    • Development sequence for program deliverables                               Requirements
    • Inputs/pre-requisites from other GMP programs                                • Critical vs. non-critical
    • Relationship between cleaning process validation and manu-
      facturing process validation                                            III. Qualification and Validation of an HVAC System
    • Establishing and defining cleaning process approach, strategy                • Design of an HVAC System – plan for compliance
      and rationale                                                                • Start-up and commissioning
    • Technical considerations: sampling and inspection, process                   • Installation and Operational Qualification of the system
      efficacy, analytical methods, equipment/process/product                      • Performance Qualification
      matrices
                                                                              IV. Qualification and Validation of a Process Water
III. Development Process for Two Key Validation                                   System
     Protocols: (1) Cleaning Process Sample Collection                             • Typical system design
     and Recovery Protocol; (2) Cleaning Process                                   • Installation and Operational Qualification
     Performance Qualification Protocol                                            • Performance Qualification
    • Common vs. unique protocol content elements
    • Strategies and information required to develop the validation           V. Qualification and Validation of Other Utilities
      approach, test plan, test cases, and acceptance criteria:                    • Design
       - Inputs/pre-requisites for protocol development and execu-                 • Commissioning
         tion                                                                      • IQ/OQ
       - Sampling and recovery method selection and testing                        • PQ (only for critical systems)
       - Specific vs. non-specific analytical methods and inspection               • Specific requirements
         techniques                                                                • Compressed gases
       - Test plans, test cases, and acceptance criteria                           • Chilled water, plant steam, solvents
       - Relationship of sample recovery and analysis criteria to
         cleaning process limits                                              VI. Maintaining Validation of a Facility/Utility System
       - Protocol outputs and related deliverables                                 • Monitoring program
                                                                                   • Maintenance requirements
IV. Interactive Exercise                                                           • Calibration of instrumentation
    Participants will use workshop information, supplemented with                  • Change control
    an imaginary cleaning process scenario, characterization data,                 • Training program for maintenance and operating personnel
    and process flow diagrams to develop a cleaning validation
    program model by identifying the necessary deliverables and               VII. Interactive Exercise
    defining key aspects of the validation approach                                Discussion of an HVAC IQ/OQ Protocol Template

                                                                              VIII. Tool Kit
                                                                                   The attendees will review in detail a protocol template for the
                                                                                   Installation Qualification/Operational Qualification of an HVAC
                                                                                   System.

                                                                              12:00 PM – Lunch for Pre-Conference
                                                                              Workshop Participants


         Institute of Validation Technology                   w w w. i v t h o m e. co m                                          218-723-9130
                                                                          3
                                                   Wednesday, June 21, 2006
                                              Main Conference 90-Minute Sessions

12:00 PM – Main Conference Registration
                                                                                         Session 2 1:30 PM – 3:00 PM
                                                                               Validation Training – How Do I Do It?
          Session 1 1:30 PM – 3:00 PM                                          Sharon Strause, Industry Consultant, formerly Senior IM Consultant, SAP
Adequate and Practical Implementation of Change                                Manager, McNeil Consumer Healthcare, a J&J Company
Control Management Before, During and After
Validation                                                                     I. Successful Validation Training: What’s it All About?
                                                                                    • Importance of Validation Training
Miguel Montalvo,Vice President,Validation Compliance, AAC
                                                                                    • Who needs training?
Consulting Group, Inc.

I. Regulatory Background and Definitions                                       II. Elements to Include in Validation Training Programs
                                                                                    • Adult Learning – Tips and Tricks
                                                                                    • Techniques and approaches to insure success
II. Specifications Change Control
    • Handling of changes to URS, FRS, Design Specifications
    • Implementing Change Control
                                                                               III. Interactive Exercise
                                                                                    A number of interactive exercises will be utilized in the session
                                                                                    to teach the principles presented.
III. Design Change Control
    • Relationship between Design Qualification/Review and
      Change Control                                                                      Session 3 1:30 PM – 3:00 PM
    • Adequate/practical Documentation Requirements for changes                Microbial Control for Regulated Manufacturing
      during design – handling of drawings
    • Functions to be involved and level of involvement
                                                                               Facilities and Equipment: Disinfectant Selection,
                                                                               Application and Validation Issues
IV. Change Control During Construction, Start-Up and                           Jim Polarine Jr.,Technical Service Specialist, STERIS Corporation
    Commissioning
    • Handling of revisions to design, drawings and specifications             I. Regulatory Expectations
    • Changes to Construction Reports/Documentation                                 • Current FDA and EMEA standards
                                                                                    • Evaluating real-world examples from industry
V. Change Control Management During                                                 • Assessing appropriate limits for manufacturing environment
   Qualification/Validation                                                           and down stream processing
    • Handling deviations resulting in a Change
                                                                               II. Equipment and Facilities Design and Operational
VI. Change Control After Validation                                                Issues Affecting Microbial Control
    • Definition of Change – planned and emergency changes                          • How the design of equipment and facility impacts contamina-
    • Requirements - QA controlled system, tracking, closure, pre                     tion control
      and post approval of changes                                                  • Cleaning versus sanitization-how effective cleaning programs
    • Adequate procedure, form and training are key to effective                      can eliminate the need for sanitization steps
      change control                                                                • Study examples from other facilities

VII. Interactive Exercise                                                      III. Sampling and Setting Limits
    Participants will develop a Change Control form for application                 • The sources of microorganisms
    before and during the validation phase of a project.                            • Evaluating selection of worst-case sample points
                                                                                    • Sampling techniques for inaccessible areas
VIII. Tool Kit                                                                      • The most common approaches to setting limits
    Procedure for Change Control Management during design
    including requirements for Design Review.                                  IV. Components of the Cleaning Validation Protocol
                                                                                    • Elements of the cleaning validation protocol
                                                                                    • Examples of cleaning validation protocols

                                                                               V. Interactive Exercise
                                                                                    This session will cover information on microbial control and val-
                                                                                    idation issues with equipment and processing areas. Attendees
                                                                                    will be asked to review information from real facilities
                                                                                    (Pharmaceutical and Biotech) and to determine actions
                                                                                    required in the development of validation protocols.



         Institute of Validation Technology                    w w w. i v t h o m e. co m                                          218-723-9130
                                                                           4
                                                   Wednesday, June 21, 2006
                                              Main Conference 90-Minute Sessions

          Session 4 1:30 PM – 3:00 PM                                                  Session 5 3:30 PM – 5:00 PM
FDA’s Systems-Based Inspections of Production                                 Introduction to Computer Validation and 21 CFR
and Process Control: Setting Up a Compliant                                   Part 11
System                                                                        Celestino De Hoyos ,ME, BSEE, Paciv, Inc.
Jackelyn Rodriguez, President, Monarch Quality Systems Solutions              Patricia Rodriguez, Computer Validation Associate, iPR
                                                                              Pharmaceuticals, a division of AstraZeneca
I. Establishing and Documenting Performance of
   Approved Manufacturing Procedures                                          I. Computer Validation
    • Training/qualification of personnel                                          • History
    • Complete master production and control records                               • Need for validating computer systems
    • Batch production and control records                                         • Definitions and general concepts
    • Process validation, including validation and security of com-                • Protocols
      puterized or automated processes
    • Identification of equipment with contents and appropriate               II. 21 CFR Part 11
      phase of manufacturing and/or status                                         • Necessity
                                                                                   • FDA Guides
II. Implementing and Documenting In-Process                                        • ER/ES Compliance
    Controls, Tests, and Examinations
    • Adherence to pre-processing procedures such as production               III. Interactive Exercise
      set-up, line clearance, etc.                                                 During the course of this session, participants will conduct two
    • Establishing time limits for completion of phases of produc-                 interactive activities. The first will be on developing a Validation
      tion                                                                         Life Cycle for a computer system/equipment and the second
    • Change control: was the need for revalidation evaluated?                     will concern developing a Gap analysis to determine if the sys-
    • Documented investigations into unexpected discrepancies                      tem/equipment needs ER/ES compliance.

III. Taking Action Based on the Severity or Frequency
                                                                                        Session 6 3:30 PM – 5:00 PM
    of Problems
    • Failure to document investigation of discrepancies
                                                                              Sample Size Determination and Sample Selection
    • Lack of process validation                                              for Process Validation
    • Pattern of incomplete or missing batch production records               Paul Pluta, Ph.D.,Validation Manager, Abbott Laboratories Global
    • Pattern of nonconformance to established in-process controls,           Pharmaceutical Operations
      tests, and/or specifications
    • Failure to establish/follow a control system for implementing           I. Approach to Process Validation Testing and Sampling
      changes in the production system operations                                  • Regulatory requirements and literature
                                                                                   • API and dosage form properties
IV. Interactive Exercise                                                           • Manufacturing processes
    Participants will analyze recent FDA warning letter observations               • Quality attribute identification
    issued as a result of inadequate Production and Process con-                   • Evaluation of specific product quality attributes
    trols; an open discussion will follow as to which may need to be               • Integration of quality attribute identification and evaluation
    addressed in order to provide a prompt response.                                 for validation protocol

3:00 PM – 3:30 PM – Refreshment Break                                         II. Application of Approach to Multiple Dosage Forms
                                                                                   • Tablet product
                                                                                   • Liquid suspension product
                                                                                   • Liquid solution product

                                                                              III. Interactive Exercise
                                                                                   Participants will develop process validation testing and sam-
                                                                                   pling plans for typical dosage forms. Participants are encour-
                                                                                   aged to propose examples for group discussion.




         Institute of Validation Technology                   w w w. i v t h o m e. co m                                          218-723-9130
                                                                          5
           Wednesday, June 21, 2006                                                             Thursday, June 22, 2006
       Main Conference General Sessions                                                   Main Conference 90-Minute Sessions

                                                                                    7:30 AM – Continental Breakfast
          Session 7 3:30 PM – 5:00 PM
Analytical Instrument Qualification
Jason Snyder, Sr. Engineer, Diosynth Biotechnology, RTP                                      Session 9 8:30 AM – 10:00 AM
                                                                                    Developing Acceptance Criteria for CSV
I. Understand FDA and USP Requirements for Analytical                               Celestino De Hoyos, ME, BSEE, Paciv, Inc.
   Instrument Qualification                                                         Patricia Rodriguez, Computer Validation Associate, iPR
    • Regulations and guidelines                                                    Pharmaceuticals, a division of AstraZeneca
    • Expectations for test parameters and acceptance limits
    • AIQ and its relation to method validation, system suitability                 I. Validation Background
      testing and quality control checks                                                 • Need for Validation
    • Terminology, scope and principles of the new USP chapter                           • Main Validation Protocols
                                                                                         • FDA Risk Assessment
II. The 4Q Lifecycle Model                                                               • HAACP
    • Purpose of equipment qualification phases
    • Detailed contents of DQ, IQ, OQ, and PQ                                       II. Acceptance Criteria
    • Initial and on-going tests                                                         • Roots
    • Responsibilities of vendors and users                                              • Common problems of Acceptance Criteria

III. Approach for Automated Systems                                                 III. How to Develop More Effective AC
    • Qualification of equipment firmware                                                • Useful Vocabulary to Develop an AC
    • Validation of computer systems connected to instruments                            • Strategies
    • Re-qualification after equipment changes                                           • Developing AC using Statistics
    • Preparing documentation
                                                                                    IV. Interactive Exercise
IV. Interactive                                                                          During the course of this session, participants will conduct two
    Classification of systems into the USP categories                                    interactive activities. The first will be on finding the problems of
                                                                                         the AC in a sample test protocol and the second will concern
                                                                                         developing an AC for the system/equipment.
           Session 8 3:30 PM – 5:00 PM
Effective Elements of a Successful Disinfectant
Validation Program                                                                            Session 10 8:30 AM – 10:00 AM
Jim Polarine Jr.,Technical Service Specialist, STERIS Corporation                   Auditing Validation Programs: What Do We Look
                                                                                    For, and When?
I. Ensuring Successful Disinfectant Validation Programs                             Jackelyn Rodriguez, President, Monarch Quality Systems Solutions
    • Disinfectant testing methodologies
    • “Real world” examples of disinfectant efficacy tests                          I. Differences in Validation Programs
    • Pitfalls encountered during testing                                                • Reasons for auditing validation programs
                                                                                         • Essential elements of a good validation program
II. Problems Related to Disinfectant Efficacy Testing                                    • Differences in validation approaches
    • Problems associated with porosity of substrates                                    • How do we ensure compliance?
    • Neutralizers that are toxic to cells
    • Recovery steps that give problematic results                                  II. Validation Program Compliance
                                                                                         • Key components to audit on a validation program
III. Regulatory Guidelines Related to Disinfectant                                       • Considerations for auditing validation programs
     Validation                                                                          • Is validation auditing the same as a gap analysis?
    • USP <1072> informational chapter                                                   • When should you consider auditing of validation programs?
    • New Aseptic Processing guidelines                                                  • Using a risk based approach when determining what valida-
    • ISO guidance documents                                                               tion programs to audit

IV. Interactive Exercise                                                            III. Reviewing Validation Protocols
    Participants will be given a disinfectant validation protocol and                    • Recording data in appropriate Forms and into the Protocol
    asked to troubleshoot the documents for possible flaws. There                        • IQ/OQ/PQ: What do you need to look at?
    will be an analysis and discussion of the protocols with a focus                     • Covering all of the right elements
    on improvements.                                                                     • What to do if gaps in validation programs are discovered?

5:00 PM – Close of Day One

          Institute of Validation Technology                        w w w. i v t h o m e. co m                                          218-723-9130
                                                                                6
                                                    Thursday, June 22, 2006
                                              Main Conference 90-Minute Sessions

          Session 11 8:30 AM – 10:00 PM                                               Session 13 10:30 AM – 12:00 PM
Nightmare on Validation Street! And Other Horror                             Reducing Validation Efforts Through
Stories: Computer Validation Compliance Issues                               Commissioning
Jerry Anderson, Director, Corporate Quality Computer Compliance,             Faris E.Yany, Ph. D., Project Director, Division of Validation and
Watson Pharmaceuticals                                                       Regulatory Compliance Services, ISS Corporation

I. Old Nightmares                                                            I. The Commissioning Scope and Strategy - Identify
    • The man who couldn’t follow his own procedures!                             • Systems and Activities
    • “Mr. Backdate” - the poor documentation practices fiend!                    • Sequences and Deliverables
    • Ugly requirements, traceless matrices!                                      • Personnel, organization, roles and responsibilities
    • “As Expected” – termination with prejudice and without objec-               • Integration with VMP and IOQ
      tive evidence!
    • And other classic horror tales...                                      II. The Commissioning Plan
                                                                                  • Buy-in from owners and stakeholders
II. New Nightmares                                                                • Key activities by system
    • The risk-based approach that increased risk!                                • Roles and responsibilities
    • The deadly shape-changing Part 11!                                          • Detail Turnover Package content
    • IT infrastructure: it has us surrounded!
    • And other new CSV thrillers...                                         III. Setting to Work
                                                                                  • The system inspection
III. Interactive Exercise                                                         • Personnel training
    Participants will band together and bravely develop methods                   • Detailed equipment inspection
    for defeating their own computer validation demons.                           • Systems, equipment, instrumentation physically complete
                                                                                  • Initial operation

          Session 12 8:30 AM – 10:00 PM                                      IV. Regulation and Adjustment
Validation Master Planning                                                        • Adjust to tolerances
Mark Kropp, MD Manager, MannKind Biopharmaceuticals                               • Generate testing data – Avoid IOQ data duplication

I. Writing a General or Specific Master Validation Plan                      V. Performance Testing
    • Generating Guidelines                                                       • Assure operational functionability
    • Composing SOPs                                                              • Cycle development
    • Establishing a Master Validation Plan
                                                                             VI. Close-Out
II. Acquiring a List of User Requirements                                         • Deviations from Commission Plan or Strategy
    • Drafting Functional Specifications                                          • Turnover and Approval
    • Creating Design Specifications
    • Systematically conducting Code Review
                                                                                      Session 14 10:30 AM – 12:00 PM
III. Writing an Installation Qualification                                   Conducting a GAP Assessment
    • Conducting an Operational Qualification                                David R. Dills, Director of Publications, Regulatory & Compliance,
    • Generating an IOQ Final Report                                         Institute of Validation Technology

IV. Performing a Performance Qualification                                   I. Gap Assessment
    • Composing a Final Summary Report                                            • Learn the benefits for conducting an assessment of your vali-
                                                                                    dation program
V. Accomplishing a Network Qualification                                          • Using different approaches: system-wide or a targeted valida-
                                                                                    tion assessment
VI. SDLC and Federal Regulations                                                  • Gap Assessment versus Audit
    • Review of Part 11 and Method of Gap Analysis                                • Prepare, execute and close-out
    • Putting it all together in one MVP                                          • Understand how to facilitate the assessment using a checklist
                                                                                    and looking for red flags
10:00 AM - 10:30 AM - Refreshment Break
                                                                             II. Documentation and Remediation
                                                                                  • Learn what documentation should be looked at: Validation
                                                                                    Master Plan, protocols, summary reports and other objective

         Institute of Validation Technology                  w w w. i v t h o m e. co m                                            218-723-9130
                                                                         7
                                                    Thursday, June 22, 2006
                                              Main Conference 90-Minute Sessions

      evidence
    • How to “fix” the known gaps within your validation program                       Session 16 10:30 AM – 12:00 PM
    • Evaluate and confirm corrective action taken                            PAT Principles Applied to High Purity Water
    • Gap Assessment report: who approves and distribution?                   Systems
    • Trending and surveillance: important tools for post-gap assess-         Bob Livingston, CTO, Arion Water
      ments
                                                                              I. Pharmaceutical Water System Designs
III. Interactive Exercise                                                          • Review pharmaceutical water system designs
    • Attendees will address a “mock”Validation Gap Assessment                     • Common problems
      and are strongly encouraged to bring real-life examples of                   • Provide highly reliable system designs
      their validation activities for group discussion.                            • Provide HP Purified quality water without sanitization or
                                                                                     reliance upon expensive vendor servicing contracts
         Session 15 10:30 AM – 12:00 PM                                       II. Detail Effective Microbial Control Strategies
Case Study for Drug Product Change                                                 • Pretreatment through to Point of Use configurations
Paul Pluta, Ph.D.,Validation Manager, Abbott Laboratories Global                   • Distribution loop designs and sanitization strategies
Pharmaceutical Operations                                                          • Materials of construction, production and storage issues
                                                                                   • Sampling concerns
I. Approach to Process Validation Change Control
    • Regulatory requirements and literature                                  III. PAT Monitoring Strategies and Data Management
    • Background assumptions and terminology                                       • Goal: automated monitoring and operation
    • Change impact evaluation, supporting information, and                        • Water System Design from a “Risk Based” approach
      documentation                                                                • Instrumentation and Data Management
    • Application of change impact evaluation to validation                        • Real Time Data- realities and limitations
      protocol                                                                     • Real Time Release of Product Water Quality

II. Case Studies: Application of Approach to Change                           12:00 PM - Lunch
    Control
    • Material changes
    • Equipment changes
    • Process changes
    • Other changes

III. Interactive Exercise
    Participants will analyze hypothetical problems and develop
    strategies based on risk assessment. Participants are encour-
    aged to propose problems for group discussion.




   HOTEL INFORMATION

   El San Juan Hotel
   & Casino
   6063 Isla Verde Avenue Carolina
   00979, Puerto Rico
   Phone: 866-317-8935
   www.thesanjuanhotel.com
   $$$$ SUPER SAVINGS $$$

   A special room rate has been prearranged for conference
   participants. Call the hotel directly at the above number and
   mention IVT to receive the reduced room rate.


         Institute of Validation Technology                   w w w. i v t h o m e. co m                                        218-723-9130
                                                                          8
                                                    Thursday, June 22, 2006
                                               Main Conference General Sessions

1:00 PM – Chairperson’s Welcome and Opening                                      3:00 PM
Remarks                                                                          Harmonization of Global CSV Regulatory
                                                                                 Requirements
1:15 PM                                                                          Herbert F. Hamilton, Life Sciences and Healthcare Regulatory Practice,
A New Era For Pharmaceutical Process Validation                                  Deloitte & Touche
Miguel Montalvo,Vice President,Validation Compliance, AAC Consulting
Group, Inc.                                                                      As a global company, is it still practical to view FDA computer system
                                                                                 validation requirements as the most stringent? Should your organi-
This session will cover key issues in current Process Validation guide-          zation focus their validation policies and procedures on FDA or man-
lines and requirements. Session highlights will include:                         age separate system development lifecycle methodologies to satisfy
     • Status of the revision to the FDA’s 1987 Process Validation               market-specific requirements? This session will present regulatory
       Guideline                                                                 requirements and challenges for regulatory authorities including
     • Requirements for Risk Assessments                                         FDA, EMEA, MHRA, and PMDA.
     • Impact of the Quality Systems Implementation and the Design                    • Current global regulatory requirements
       for Quality Concepts.                                                          • Harmonization efforts and international standards
     • Continuous Product Quality Verification and PAT Applications                   • Challenges and opportunities working with domestic and
     • Process Analysis of Critical Process Capability and Critical                     international affiliates
       Quality Attributes                                                             • Value-based Validation
     • Continuous Process Improvement                                                 • Steps to harmonize global CSV regulatory requirements and
     • Application of Statistical Tools                                                 enhance your organization’s system development lifecycle to
     • Use/analysis of the Routine Monitoring Data                                      achieve the optimal balance of the cost of validation and the
                                                                                        cost of compliance.
1:50 PM
How Much Documentation is Enough?                                                3:35 PM
Sharon Strause, Industry Consultant, formerly Senior IM Consultant, SAP          Equipment Validation: Determining the True
                                                                                 Requirements for the Entire Program
This session will review an approach to determine how much docu-                 Jason Snyder, Senior Engineer, Diosynth Biotechnology
mentation is necessary in computer system validation.
     • Focus and Documentation                                                   This session will focus on examining the entire equipment program
     • Protocols and Procedures                                                  to ensure you are meeting your needs while using the true require-
     • Guidelines and Approach                                                   ments.There are lots of industry standards and some documents
     • Record Retention                                                          that state the requirements. We will review the best and most effi-
                                                                                 cient way to determine those requirements. The session will discuss
2:25 PM                                                                          various places those standards can be placed as well as who should
FDA’s Latest Compliance Policy Guide (CPG)                                       monitor them.
                                                                                      • Determining basic requirements
Relating to Process Validation
                                                                                      • Evaluate how different aspects and requirements of the vari-
David R. Dills, Director of Publications, Regulatory & Compliance,
                                                                                        ous validations as well as the process can fulfill those needs
Institute of Validation Technology
                                                                                      • How risk assessment can help you reduce your documents and
                                                                                        testing
CPG and Process Validation Requirements for drug products and
Active Pharmaceutical Ingredients subject to pre-market approval, as                  • Evaluate potential issues
well as inspectional trends under CPG, will all be covered during this
session.
     • Latest guidance issued by FDA for Section 490.100 and CPG
       7132c.08
     • Understand policy, enforcement implications and who is
       impacted
     • What are conformance batches and other terminology?
                                                                                    Interested in Exhibiting?
     • Learn what investigators are looking for during pre-approval
       and post-approval                                                            Exhibitor and sponsorship opportunities are
     • Why the CPG references CPGM 7356.002, Q7A (APIs) and                         available for this and other IVT conferences.
       Guidelines of General Principles of Process Validation from
       1987?
                                                                                    Please contact Michele Leyden,Sales Manager
     • Future direction
                                                                                    800-276-4242 (U.S.toll-free)
                                                                                    or 954-567-9402
                                                                                    mleyden@advanstar.com

          Institute of Validation Technology                     w w w. i v t h o m e. co m                                         218-723-9130
                                                                             9
            Thursday, June 22, 2006                                                               Friday, June 23, 2006
       Main Conference General Sessions                                                    Post-Conference Half-Day Workshops

4:10 PM                                                                               7:30 AM – Continental Breakfast
Deviation Reduction for Validation
Crisanta Fasano, Ph.D., Senior Research Scientist, Eli Lilly and Company
                                                                                               Workshop E 8:30 AM – 12:00 PM
This session will address ways to prevent or reduce deviations dur-                   Using Statistics for an Effective Process Validation:
ing process validations. The potential sources of deviations with real                From Development to Monitoring and Process
examples will be discussed. Eliminating deviations due to avoidable                   Optimization
execution errors through proper communication and coordination                        Miguel Montalvo,Vice President,Validation Compliance, AAC
among different functional areas will be covered in detail.                           Consulting Group, Inc.
Documentation, including assessments and risk analysis, will also be
included.                                                                             I. Why Statistical Tools?
     • Learn the common sources of deviations and how to minimize                          • Regulatory references
       or avoid them
     • Understand how knowledge of product and process critical                       II. Understand the Different Tools Available and Their
       parameters help in formulating appropriate acceptance criteria                     Basic Application
     • Understand the planning stage                                                       • Application of statistical tools at different phases
     • Learn the role of development work, process data mining, and                        • Tools for use after process validation
       risk analysis on process validation                                                 • Differences between Attribute data and Variable data
                                                                                           • Determining the best statistical technique
4:45 PM – Close of Day Two
                                                                                      III. Design of Experiments and Their Applications
5:00 PM – Networking                                                                       • Basic requirements of a Design of Experiments
Cocktail Reception                                                                         • Matrices at different levels
                                                                                           • Matrix-size for specific applications or phases in the
                                                                                             product/process life cycle.

                                                                                      IV. Sampling Plans – Attribute Versus Variable Sampling
                                                                                           • Differences between attribute versus variable sampling
    Registration is                                                                        • Application of the ANSI/ASQ Standard for Attribute sampling
                                                                                             plans

    just a click away.                                                                V. Process Capability Studies – Application During
                                                                                         Development and During Actual Process Validation
      www.ivthome.com                                                                      • Process Capability Analysis
                                                                                           • During Process Development - determining parameter ranges
    Now offering online registration                                                       • During Process Validation – determining process capability
                                                                                           • Drawing conclusions
    for all IVT conferences.
                                                                                      VI. Routine Monitoring – Process Control Charts
    These industry events offer the
                                                                                           • Participants will become familiar with:
    opportunity to attend single                                                             - different types of control charts – X-Bar/R chart, p-chart
    workshops or the entire                                                                  - sampling for control charts – sample size and frequency
    program. Attendees                                                                       - how to calculate the limits and apply them to the chart
    can design their                                                                         - draw the data points and make conclusions
    own conference                                                                           - understand trends, shifts.
    by choosing from
                                                                                      VII. Interactive Exercise
    various 90-minute,
                                                                                           Participants will be presented with a set of data and they will
    half-day, and                                                                          evaluate the information, determine the adequate tool and use
    interactive sessions.                                                                  it to analyze the data. At the end of the activity, they will draw
                                                                                           conclusions on the acceptability of the data.

                                                                                      VIII. Toolkit
                                  Visit us at www.ivthome.com                              Article on sample determination for Process Capability.
                                  or email us at registration@ivthome.com
                                                                                           Templates for Process Control Charts documentation and other
                                  for more information
                                                                                           statistical analysis


         Institute of Validation Technology                           w w w. i v t h o m e. co m                                          218-723-9130
                                                                                 10
                                                     Friday, June 23, 2006
                                              Post-Conference Half-Day Workshops

           Workshop F 8:30 AM – 12:00 PM                                                 Workshop G 8:30 AM – 12:00 PM
A Lifecycle Approach to Laboratory Method                                       Applying the IVT Infrastructure Qualification
Validation                                                                      Standard
Rebecca Buede, MS,Validation Consultant, Central Quality, Roche                 Jerry Anderson, Director, Corporate Quality Computer Compliance,
Diagnostics Operations                                                          Watson Pharmaceuticals

I. Application of the Lifecycle Concept to Laboratory                           I. The Case for Qualifying Your IT Infrastructure
   Method Validation Program                                                          • Compliance: Regulatory agency expectations
    • Procedures                                                                      • Business benefits of qualifying infrastructure
    • Lifecycle model description                                                     • The purpose of the IVT Standard
    • Utility and basis for this approach                                             • The IVT Standard and The GAMP Best Practice Guide
    • Inter-relationships between lifecycle stages
    • Inter-relationships between the method lifecycle and others               II. Qualification Foundations
                                                                                      • Qualification vs. validation
II. Laboratory Method Validation Concepts                                             • Initial vs. retrospective qualification
    • Validation approaches                                                           • Good engineering and QA best practices
    • Types of validation exercises                                                   • Hardware and software standards
    • Determination of method type and origin                                         • Qualified staff
    • Selection of analytical performance characteristics                             • Supplier management and configuration management
    • Selection of sample matrix
                                                                                III. Risk Management
III. Development and Planning                                                         • Risk assessment, evaluation, and mitigation
    • Method development and characterization report                                  • Documentation of rationale
    • Establishment of analytical specifications and procedures
    • Use of Impact Assessments to define the analytical method                 IV. Prospective Qualification Methodology
      quality approach                                                                • Document deliverables
    • Validation planning for the analytical laboratory                               • Planning, Design, and Build and Test Phases
                                                                                      • Installation and Verification
IV. Testing and Acceptance                                                            • Operations and retirement
    • Protocol content elements
    • Identification and verification of validation pre-requisites              V. Retrospective Qualification: Practical Application of
    • Verification of test case pre-execution conditions                           the IVT Standard
    • Validation test plan elements                                                   • Understanding your existing infrastructure
    • Designing analytical performance test cases                                     • Deciding what to qualify
                                                                                      • Setting the appropriate standards to meet
V. Implementation to Routine Use                                                      • Qualification approach and deliverables
    • Post-execution review and acceptance of validation results                      • Best practices for making qualification easier
    • Release for use                                                                 • Maintaining the qualified state
    • Implementation action plans and verification                                    • Best practices for keeping costs down over time

VI. Maintaining the Validated State                                             VI. Interactive Exercise
    • Relationship of validation results to laboratory QA and QC                      Participants will discuss strategies for qualifying their own IT
    • Monitoring and surveillance of validated methods                                infrastructure and best practices performed by those who
    • Change management and revalidation                                              have completed qualification.
    • Method retirement/replacement
                                                                                VII. Tool Kit
VII. Interactive Exercise                                                             All participants will receive a copy of the IVT Network
    Participants will be given a laboratory method validation proj-                   Infrastructure Qualification Proposed Standard.
    ect scenario and will be asked to apply the information shared
    during the workshop to identify and sequence lifecycle deliv-
    erables and to develop the content outline of a laboratory
    method validation protocol.




         Institute of Validation Technology                     w w w. i v t h o m e. co m                                          218-723-9130
                                                                           11
                                                     Friday, June 23, 2006
                                              Post-Conference Half-Day Workshops

                                                                                      • Implementing sampling methods
         Workshop H 8:30 AM – 12:00 PM                                                • Selecting test sites - factors to consider
Streamlining and Fast Tracking Your Validation                                        • Routine monitoring
Projects                                                                              • Utilize disinfectants and contamination control
Thomas Dzierozynski,Vice President,Validation Services, Quintiles
Consulting                                                                       III. Validation
                                                                                      • What and how to Validate
I. Validation in the Life Science Industry                                            • Hot Buttons
    • Validation – concepts and definitions                                           • Avoiding common mistakes
    • The impact of compliance and validation on a business                           • Revalidation requirements
    • Cost-Benefit considerations                                                     • Basic Microbiology
    • Life cycle within pharmaceuticals and medical devices                           • Media fills including interventions and aseptic technique
    • Business affect of FDA’s cGMPs for the 21st Century                               observation/documentation

II. Integrated Tools                                                             IV. Operations
    • Existing efficiency drivers – lean / six sigma / ISO – risk man-                • Good aseptic processing techniques
      agement                                                                         • Gowning training and personnel certification
    • Organizational assessment tools                                                 • Special considerations - shutdown
    • Commissioning and validation                                                      Activities/Expansions/Upgrades
    • Industry initiatives                                                            • Training and records keeping - data traceability

III. Integrated Program Management                                               V. Interactive Exercise
    • Establishing validation performance metrics                                     In this exercise, the participants will work on a special project
    • Compliance process simplification                                               involving the reclassification of an existing area. The partici-
    • When and how to establish validation services partnerships                      pants will have to develop an implementation schedule that
    • Common causes of project failures                                               considers FDA submission, a validation strategy and finally nor-
                                                                                      mal operation activities.
IV. Maintaining the Validation Life Cycle
    • Defining and implementing change control and review
    • Validation and the Quality System
                                                                                           Workshop J 1:30 PM – 5:00 PM
    • Structuring calibration and preventative maintenance                       Risk Assessment Strategies and Applying FMEA to
                                                                                 Validation
V. Interactive Exercise                                                          David R. Dills, Director of Publications, Regulatory & Compliance,
    The interactive exercise will cover specific “how to” and “how               Institute of Validation Technology
    not to” themes to help avoid making similar mistakes and to be
    better prepared to deliver validation in a smarter and more effi-            I. Risk Assessment Techniques and Approaches
    cient way.                                                                        • Introduction to various risk assessment tools and strategies
                                                                                      • Why the emphasis on risk-based approaches from pre-market-
12:00 PM – Lunch                                                                        ing to post-marketing?
                                                                                      • Cradle to Grave approaches for risk assessment
                                                                                      • Understand why ISO 14971 is important
         Workshop I 1:30 PM – 5:00 PM
Clean Room Certification, Validation and                                         II. Conducting a Failure Mode & Effects Analysis and
Operations in Aseptic Environments                                                   Impact on Validation
Oscar Ortiz, Project Manager,Validation Services, Quintiles Consulting                • Learn the terminology and how to execute FMEA effectively
                                                                                      • Three types of FMEAs: design, process and system
I. Aseptic Environments                                                               • Identify potential failure modes and rate the severity of their
    • Definition and scope of aseptic processing                                        effects
    • Facility design and environmental consideration                                 • Identify critical characteristics and rank potential design and
    • Determining viable and non-viable considerations                                  process deficiencies
    • Analysis/control of processing environment                                      • Risk Priority Numbers
    • Determine factors to avoid                                                      • Learn why FMEA can help engineers focus on eliminating
    • Developing room classifications                                                   product and process concerns
    • FDA Requirements and Guidance                                                   • Areas where FMEA can be beneficial
                                                                                      • Criticality & Complexity and CCPs
II. Addressing the Principles for Aseptic Processing                                  • Used to justify “statistical risk” chosen and used to limit factors
    • Attributes of clean room management                                               to include in worst case testing

         Institute of Validation Technology                      w w w. i v t h o m e. co m                                           218-723-9130
                                                                            12
                                                     Friday, June 23, 2006
                                              Post-Conference Half-Day Workshops

III. FDA and Regulatory Guidance and Expectations                              V. Interactive exercise
    • Brief overview of recent ICH risk-based documentation                         In this interactive activity, Minitab® will be used to illustrate the
    • ISO 14971 is still well received by industry                                  process of screening and optimizing settings of key factors for a
    • More companies are using PAT and integrating science & risk                   hypothetical process. The group will choose factors to study,
      based regulatory approaches                                                   strategically set levels for those factors, and select a design that
    • Brief update on FDA’s risk-based method for prioritizing cGMP                 will effectively and efficiently reveal the process attributes.
      inspections                                                                   Participants will be able to interpret and adapt to the program
    • Recent warning letters and inspectional trends                                output, striving to optimize the process.

IV. Interactive Exercise
    Attendees will be introduced to a FMEA activity and are strong-                     Workshop L 1:30 PM – 5:00 PM
    ly encouraged to bring real-life examples of their validation              Global Computerized System Validation
    activities for group discussion. Examples of various FMEA activi-          Rachel Burn MSc, BSc (Hons), Member of BCS and ISPE. Head of
    ties for pharmaceutical and medical device manufacturing                   Computer System Quality Assurance,Wyeth Europa
    applications will be addressed.
                                                                               I. Global Computerized Systems (GCS): What Are They?
                                                                                    • Explanation
           Workshop K 1:30 PM – 5:00 PM                                             • Example definitions
Design of Experiments (DOE): Effective and                                          • What they are not?
Efficient Strategies for Process and Analytical
Development and Validation                                                     II. Global Computerized System Options and Factors
Timothy Schofield, Senior Director,Vaccine Biometrics Research, Merck              That Can Influence Your Choice
Research Laboratories                                                               • Possible “flavors of GCS, from “diet” through to “full fat”
                                                                                    • Items for immediate consideration before beginning with a
I. Decision-Making in the Face of Uncertainty                                         GIS
    • Understanding variability                                                     • Factors that can limit GIS options
    • Managing variability
    • Communicating variability                                                III. GCS: High Level Pros and Cons
    • Decision making                                                               • Issues with cost, risk, time and maintenance
                                                                                    • Benefits to the user and the business
II. Multifactor Design Of Experiments (DOE)                                         • Benefits to IT
    • DOE vs. one factor at a time (OFAT) experimentation
    • Screening designs                                                        IV. GCS Validation Strategy
    • Full factorial and fractional factorial designs                               • What is required?
    • Projective properties of Plackett-Burman designs                              • Items for immediate consideration
    • Optimization                                                                  • Core versus local?
    • Other designs                                                                 • Globalization of validation lifecycle activities
                                                                                    • Globalization of supporting activities
III. Using DOE to Gain Process Understanding                                        • What can be done with the right strategy
    • Process optimization
    • Process robustness                                                       V. Interactive Exercise
    • An optimization case study                                                    In this interactive activity, the goal is to maximize the efficiency
    • A robustness case study                                                       and robustness of a GIS Validation Strategy and necessary sup-
                                                                                    porting processes for your selected system.The overall group
IV. Using DOE in Analytical Method Development and                                  will define a selection of key validation and support
    Validation                                                                      activities/deliverable and then, in smaller groups, decide how
    • DOE in development                                                            best to apply them to a selection of different GIS options.
    • DOE in validation                                                             Participants will also discuss any possible additional items,
    • Validation designs                                                            which may be beneficial and appropriate in each case.
    • Using variance component analysis to understand and control
      variability                                                              5:00 PM – End of Conference
    • A development case study
    • A validation case study




         Institute of Validation Technology                    w w w. i v t h o m e. co m                                           218-723-9130
                                                                          13
             Validation Workshop Series - San Juan, Puerto Rico – El San Juan Hotel
                                      June 21 – 23, 2006

  WEDNESDAY, JUNE 21, 2006                    3:00 PM – 3:30 PM                        Main Conference                       FRIDAY, JUNE 23, 2006
                                              Refreshment Break                        90-Minute Sessions
7:30 AM – Registration and                                                             10:30 AM – 12:00 PM              7:30 AM – Continental
Continental Breakfast                         Main Conference                                                           Breakfast
                                              90-Minute Sessions                       SESSION 13
Pre-Conference                                3:30 PM – 5:00 PM                                                         Post-Conference
                                                                                       Reducing Validation Efforts
Half-Day Workshops                                                                                                      Half-Day Workshops
                                                                                       Through Commissioning
8:30 AM – 12:00 PM                            SESSION 5                                                                 8:30 AM – 12:00 PM
                                              CVS and 21 CFR Part 11                   SESSION 14
WORKSHOP A                                                                                                              WORKSHOP E
                                                                                       Using GAP Analysis to
Process Validation: An                        SESSION 6                                Determine Where Your             Statistics in Validation
Implementation Roadmap                        Sample Size Determination and            Validation Program is Most
                                              Sample Selection for Process             Vulnerable                       WORKSHOP F
WORKSHOP B                                    Validation                                                                Analytical Method Validation
Introduction to Risk Based                                                             SESSION 15                       Challenges and Solutions
Computer System Validation                    SESSION 7                                Case Study for Drug Product
                                              Analytical Instrument                    Change                           WORKSHOP G
WORKSHOP C                                    Qualification                                                             Applying the IVT Infrastructure
Introduction to Cleaning                                                               SESSION 16                       Qualification Standard
Validation                                    SESSION 8                                PAT Principles Applied to High
                                              Effective Elements of a                  Purity Water Systems             WORKSHOP H
WORKSHOP D                                    Successful Validation Program                                             Streamlining and Fast Tracking
Strategies for Effective Design                                                        12:00 PM - Lunch                 Your Validation Projects
and Qualification of                          5:00 PM – Close of Day One
Pharmaceutical Facility and                                                            Main Conference                  12:00 PM – Luncheon
Utility Systems.                                                                       General Sessions
                                                 THURSDAY, JUNE 22, 2006                                                Post-Conference
12:00 – Lunch for                                                                      1:00 PM – Chairperson’s          Half-Day Workshops
Pre-Conference Workshop                       7:30 AM – Continental                    Welcome and Opening              1:30 PM – 5:00 PM
Participants                                  Breakfast                                Remarks
                                                                                                                        WORKSHOP I
12:00 – Main Conference                       Main Conference                          1:15 PM
                                                                                                                        Clean Room Certification,
Registration                                  90-Minute Sessions                       A New Era for Pharmaceutical
                                                                                                                        Validation and Operations in
                                              8:30 AM – 10:00 AM                       Process Validation
                                                                                                                        Aseptic
Main Conference
90-Minute Sessions                            SESSION 9                                1:50 PM
1:30 PM – 3:00 PM                                                                      How Much Documentation is        WORKSHOP J
                                              Developing Acceptance Criteria                                            Risk Assessment Strategies and
                                                                                       Enough?
SESSION 1                                                                                                               applying FMEA to Validation
                                              SESSION 10                               2:25 PM
Adequate and Principal                        Auditing Validation Programs:
Implementation of Change                                                               FDA’s Compliance Policy Guide    WORKSHOP K
                                              What do We Look For, and                 (CPG) Relating to Process        Design of Experiments (DOE):
Control Management Before,                    When?
During and After Validation                                                            Validation                       Effective and Efficient Strategies
                                                                                                                        for Process and Analytical
                                              SESSION 11                               3:00 PM                          Development and Validation
SESSION 2
                                              Nightmare on Validation Street!          Harmonization of Global CSV
Validation Training – How Do I                And Other Horror Stories:                Regulatory Requirements
Do It?                                                                                                                  WORKSHOP L
                                              Computer Validation                                                       Global Computerized System
                                              Compliance Issues                        3:35 PM                          Validation
SESSION 3                                                                              Equipment Validation:
Microbial Control for Regulated               SESSION 12                               Determining the True             5:00 – End of Conference
Manufacturing Facilities and                                                           Requirements for the Entire
                                              Validation Master Planning
Equipment: Disinfectant                                                                Program.
Selection, Application and                    10:00 AM – Refreshment
Validation Issues                             Break                                    4:10 PM
                                                                                       Deviation Reduction for
SESSION 4                                                                              Validation
FDA’s Systems-Based
                                                                                       4:45 PM – Close of Day Two
Inspections of Production and
Process Control: Setting Up a
                                                                                       5:00 PM – Networking
Compliant System
                                                                                       Cocktail Reception



         Institute of Validation Technology                            w w w. i v t h o m e. co m                                     218-723-9130
                                                                                  14
  VALIDATION WORKSHOP SERIES • June 21 - 23, 2006 • San Juan, Puerto Rico • El San Juan Hotel & Casino
   Complete this registration form, include payment in U.S. funds, and send to:
                                                                                                                            For hotel information see page 8.
   Advanstar/Institute of Validation Technology • PO Box 6004, Duluth, MN 55806-6004
   888.524.9922 (U.S. only) or 218.723.9130 (U.S. or international) • Fax: 218.723.9308 • E-mail: Registration@ivthome.com • www.ivthome.com

              REGISTER ONLINE AT:                                                              You MUST mark the sessions and workshops you will be attending.
              http://www.ivthome.com                                                           Fax, E-mail, Mail, or Call Us Today. Payment is required at time of registration.
                                                                                               Registration Form: Print Clearly or Attach Business Card.
                                                                                                                                               Customer ID:
    Please choose one breakout session in each timeframe.                                      Enter Customer ID from Mail Panel :

Wednesday, June 21, 2006                                                                       Name ________________________________________________________________
Pre-Conference Half-Day Workshops                                                                       FIRST                                        LAST

   8:30 AM – 12:00 PM .......................................................... $795 USD      Title: _________________________________________________________________
      A■       B■          C■                 D ■(Choose one)
                                                                                               Organization: __________________________________________________________
   ■ Wednesday - Thursday, June 21 - 22, 2006
       MAIN CONFERENCE: General Sessions and                                                   Mailing Address:________________________________________________________
       Inclusive Interactive Sessions: ..............................$1995 USD
   Wednesday, June 21, 2006                                                                    City: _________________________________________________________________
   Main Conference 90-Minute Interactive Sessions:
   1:30 PM – 3:00 PM                                                                           State:__________ Zip/Postal Code:_________________________________________
    1■       2■       3■       4 ■ (Choose one)
                                                                                               Country: ______________________________________________________________
    3:30 PM – 5:00 PM
     5■       6■                   7■             8 ■ (Choose one)                             Telephone: (         ) _____________________________________________________
   Thursday, June 22, 2006
   Main Conference 90-Minute Interactive Sessions                                              Fax: (       ) ___________________________________________________________
    8:30 AM – 10:00 AM
    9■        10 ■     11 ■    12 ■ (Choose one)                                               E-mail: _______________________________________________________________
                                                                                                        Please include for confirmation of registration. Allow three days for processing.
    10:30 AM – 12:00 PM
    13 ■     14 ■       15 ■                      16 ■ (Choose one)
                                                                                               Payment method: ■ VISA ■ MC ■ AMEX ■ Check Payable to Advanstar/IVT

Friday, June 23, 2006                                                                          Credit Card #: __________________________________________________________
Post-Conference Half-Day Workshops
   8:30 AM – 12:00 PM............................................................$795 USD      Exp. Date: _____________________________________________________________
   E■        F■        G■                   H ■ (Choose one)
    1:30 PM – 5:00 PM...............................................................$795 USD   Cardholder’s Name (PLEASE PRINT): _____________________________________________
    I■        J■          K■                   L ■ (Choose one)
                                                                                               Signature: _____________________________________________________________


    ■ The Ultimate Passport $2595 USD                                         SAVE
    Attend the entire event at this best value price.                        OVER              COST TOTALS: VALIDATION WORKSHOP SERIES
    The Passport Includes:                                                   $1700             Wednesday, June 21, 2006
    • One Pre-Conference Workshop
    • Full Main Conference Wednesday through Thursday                                          Pre-Conference Workshops A – D                         $795 USD          $ _____________
    • Two Post-Conference Half-Day workshops
                                                                                               Wednesday – Thursday, June 21 - 22, 2006
    • Networking and Cocktail Reception on Thursday
                                                                                               Main Conference includes General
    Passport registrants must check the boxes of the                                           Sessions and Interactive Sessions 1 – 16 $1995 USD                       $ _____________
    workshops and sessions that they wish to attend!
                                                                                               Friday, June 23, 2006
                                                                                               Post-Conference Half-Day
✹ Multiple Registrations: Send three attendees and the fourth is FREE!                         Workshops E – H                                        $795 USD          $ _____________
✹ Early Bird Discount: Register early and send in payment before April 25,2006
                        and receive a 10% discount!                                            Friday, June 23, 2006
                                                                                               Post-Conference Half-Day
Method of Payment: Please note that payment is required in advance of the confer-
ence. Please make checks (in U.S. funds drawn on a U.S. bank) payable to                       Workshops I – L                                        $795 USD          $ _____________
IVT/Advanstar Communications. Confirmation of your registration will be sent. Full
payment must accompany registration form. Registrations received without payment               OR
will not be processed.
                                                                                               The Ultimate Passport                                $2595 USD           $ _____________
Cancellations/Substitutions: Your registration form may be transferred to a member
of your organization at any time. Requests for cancellations (by mail or fax) must be          SUB TOTAL                                                                $ _____________
received by June 6, 2006 in order to receive credit for attending another IVT event.
Please be aware that cancellations will not be accepted after that date. All cancellations     ✹Early Bird Discount - 10%                                               $ _____________
are subject to a $325.00 processing fee. IVT reserves the right to cancel an event. IVT is
not responsible for any airfare, hotel, or other costs incurred by registrants. Speakers       TOTAL Enclosed                                                           $ _____________
subject to change without notice.
                                                               Federal Tax ID # 592757389
                                                                                                                                                                                            #873606
                               Puerto Rico’s Largest and Most Comprehensive Validation Event!



         Validation Workshop Series
         June 21 - 23, 2006 • San Juan, Puerto Rico • El San Juan Hotel & Casino

Hear from Validation Experts from 21 Pharmaceutical,
Biotechnology, Manufacturing and Allied Companies…
• AAC Group                                           • McNeil Consumer Healthcare
• Abbott Laboratories                                 • Merck & Co., Inc.
• Arion Water, Inc.                                   • Monarch Quality Systems Solutions             CREATE-
• AstraZeneca                                         • Paciv, Inc.                                 YOUR-OWN
                                                                                                  CONFERENCE:
• Boston Scientific                                   • Quintiles Consulting
                                                                                                 CHOOSE FROM
• Deloitte & Touche LLP                               • Roche Diagnostics Corporation
• Diosynth Biotechnology RTP
• Eli Lilly and Company
                                                      • STERIS Corporation
                                                      • Watson Pharmaceuticals
                                                                                                       35
                                                                                                  INTERACTIVE
• ISS Corporation                                     • Wyeth, Inc.                              WORKSHOPS,
                                                                                         EFORE
• Institute of Validation Technology                                           REGISTER B           EXPANDED
                                                                                            06
• IPR Pharmaceuticals                                                           APRIL 25, 20         SESSIONS,

                                                                               SAVE 10%!
                                                                                                 AND GENERAL
• MannKind BioPharmaceuticals                                                                        SESSIONS




                                              Customer ID:
         PO Box 6296
    Duluth, MN 55806-6296
             USA

If addressee is no longer at this
address, please forward to:
■ Production/Manufacturing
■ Quality Assurance/Quality Control
■ Regulatory

■ Research and Development

■ Lab Manager

■ Validation Department

■ Statistics

■ Biometrics

								
To top