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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 • firstname.lastname@example.org 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 email@example.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 firstname.lastname@example.org 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. 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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