Corrective And Preventive Action - CAPA by odq14517


									               FDA Warning Letter Excerpt: “... failed to establish procedures to verify, validate
            and implement corrective and preventive actions and ensure that relevant information is
                                    submitted for management review...”

            CORRECTIVE AND
                   TER by
             REGIS 8th and

             August ive a
              $300 d

                                                   September 25-26, 2006 • Tremont Marriott • Boston, MA
                                                            Develop Practical Approaches to Implement,
                                                       Maintain and Manage a Compliant CAPA System


                        WYETH                                   JOHNSON & JOHNSON
          Implementing Execution Excellence                Lessons Learned from Implementation
            to Improve CAPA Effectiveness                      of a World-Class CAPA System

 UPDATE          GE HEALTHCARE                                        PDL BIOPHARMA
             Emergent Regulations Related                    Strategies for Successful Evaluation
               to Root Cause Analysis                                 of a CAPA System
                                              9 CASE STUDIES FROM
                                             MAJOR PHARMACEUTICAL
            SPARTA SYSTEMS, INC.                                 TAP PHARMACEUTICAL                     SESSION

          Key Success Factors for Implementing                      PRODUCTS, INC.
              a Global Electronic Quality                    Trending and Analysis of Data from
                 Management System                              CAPA and Complaint Systems

                     SDLS CORP.                                  AMADEUS SOLUTIONS
                                                               Successful Training Strategies to
                   How to Effectively
                                                                  Ensure an Optimal CAPA
                Validate a CAPA System                               System Deployment

                                                                                       …..AND MANY MORE
 REGISTER NOW! Call 813-655-7788 or email: or go to:

                                Organized By: SWE Enterprises • P.O. Box 23202 • Tampa, Florida 33623
                                Telephone: 813-655-7788 • Fax: 413-480-9953 • Website:        1
                                        FDA Warning Letter Excerpt: “... failed to established procedures to analyze and
                                          document quality data to identify and investigate existing or potential causes
                                                   of non-conforming products or other quality problems.”

                          DAY ONE                                        12:00 LUNCHEON
                 MONDAY, SEPTEMBER 25, 2006
                                                                                 IN-DEPTH SESSIONS ON CAPA
                                                                                AND MEDICAL DEVICE INDUSTRIES
               OPENING REMARKS
                                                                         CASE STUDY

                                                                         1:00     LESSONS LEARNED FROM IMPLEMENTATION
               IMPROVE CAPA EFFECTIVENESS                                         OF A WORLD-CLASS CAPA SYSTEM
                                                                                  Miguel Avila, Worldwide Director of Quality
      9:00     WORKSHOP BEGINS                                                    CORDIS CORPORATION, A JOHNSON &
               John A. Shaeffer, Training Consultant
                                                                                  JOHNSON COMPANY
 RECENT FDA    Amy M. Peterson, Sr. QA Specialist
               WYETH                                                     This session will address the process and software challenges in
      This workshop offers an explanation for why procedure related      meeting the regulatory and business requirements for a World-
      events dominate the top ten FDA audit findings and why typical     Class Corrective and Preventive Action (CAPA) System. The
      industry CAPA (Corrective & Preventive Action) systems are         presentation will focus on the following areas:
      not having the desired impact. Execution Excellence will fur-
      ther explain steps organizations can take to improve CAPA            •   Aligning processes
      effectiveness, including procedure related events and inadver-       •   Meeting regulatory requirements
      tent errors. Execution Excellence methodology has been               •   Leveraging technology
      proven effective in regulated industries over the last 15 years.     •   Applying risk management
      This workshop will examine:                                          •   Addressing cultural changes

        • A quick way of predicting corrective action effectiveness      CASE STUDY
          and CAPA program effectiveness
        • The typical organizational progression in implementing a       2:00     CHALLENGES FOR MEDICAL DEVICE
          CAPA system                                                             COMPANIES TO IMPLEMENT CAPA AND
        • How common solutions are really common mistakes in a                    UTILIZE A CAPA SYSTEM
          CAPA system                                                             Sue Jacobs, President
        • Typical reactions to events and how they lead to
                                                                                  QMS CONSULTING, INC.
        • Top 10 FDA citations and solutions
                                                                         Greater than 50% of FDA Warning Letters and 483 citations
        • 20 years of lessons learned implementing CAPA
                                                                         were CAPA related in 2005. Many firms are facing similar
        • Principles, application, and benefits of the Execution
                                                                         challenges, aging CAPAs, failed effectiveness checks, an inade-
          Excellence Model
                                                                         quate procedure, CAPA system too complex, lack of manage-
                                                                         ment support. This session will discuss these challenges and
      About the workshop leaders: John A. Shaeffer from Wyeth            more and provide strategies and tips on how to deal with them.
      Biotech has over 28 years in industrial operations spanning
      both the nuclear and pharmaceutical/biotechnology industries.
                                                                           •   Conflicting priorities and competing resources
      He has designed, produced and implemented manufacturing,
                                                                           •   Dealing with aging CAPAs
      quality, engineering, management and training systems using
                                                                           •   Why effectiveness checks fail and what to do about it
      Execution Excellence principles. John also has developed
                                                                           •   Unique challenges for global manufacturers
      CAPA and CAPA effectiveness measurement systems and has
      experience using Six Sigma and Lean Manufacturing tools.
                                                                         2:45     AFTERNOON BREAK - 7TH INNING STRETCH
      Amy M. Peterson, MS is a Sr. QA Specialist for Wyeth
      Biotech and has over 11 years of pharmaceutical industry expe-
      rience. Amy has designed, implemented and evaluated CAPA
      and CAPA effectiveness measurement systems. Her back-
      ground also includes evaluating and improving quality and
      manufacturing processes using principles and tools from Six
      Sigma, Lean Manufacturing and Execution Excellence.

         REGISTER NOW! Call 813-655-7788 or email: or go to:                                         2
FDA Warning Letter Excerpt: “... failed to establish and maintain procedures for implementing corrective and
                                               preventive actions (CAPA) …”

  CASE STUDY                                                         5:15     INTERACTIVE PANEL DISCUSSION:
                                                                              CURRENT ISSUES IN FDA CITATIONS
  3:00      IMPLEMENTING A COMPUTERIZED                                       REGARDING CAPA SYSTEMS
            CAPA SYSTEM
                                                                              INCLUDING ALL DAY ONE SPEAKERS
            Phil Lofty, Manager
            ALLERGAN                                                   • Current Industry CAPA Practices
                                                                       • Lessons Learned from Implementation and Maintenance
  This session will address strategies for implementing a comput-        of a CAPA System
  erized CAPA System with many diverse locations and the orga-         • FDA 483’s and Warning Letters
  nizational benefits of a centralized system. Defining needs and      • Question and Answer
  requirements that all locations can agree on is a challenging
  task, vendor selection and streamlining the use between the        5:45     END OF DAY ONE
  locations. The following areas will be examined:
                                                                                           DAY TWO
    •    Definition of Needs                                                     TUESDAY, SEPTEMBER 26, 2006
    •    Selection of Supplier
    •    Harmonization of Sites                                      7:30    BREAKFAST
    •    Design to Delivery
                                                                     8:30    CHAIRPERSON’S WELCOME
            TO ROOT CAUSE ANALYSIS                                          EXTENDED SESSION ON CAPA TRAINING
            Dr. Sandy Weinberg, Senior Director,
 FDA                                                                 8:45     SUCCESSFUL TRAINING STRATEGIES
            Fast Track Vaccines, GE HEALTHCARE
                                                                              TO ENSURE AN OPTIMAL CAPA
  This session discusses the latest FDA (and other regulatory                 SYSTEM DEPLOYMENT
  agency) guidelines that apply to the use and interpretation of              Amy L. Carlson, Senior Product Manager
  Root Cause Analysis. Issues include:                                        AMADEUS SOLUTIONS, INC.

    • Risk Analysis                                                  Many organizations have invested in software solutions in order
    • Use of Predicate Data in Analysis                              to more effectively identify and monitor corrective and preven-
    • New FDA philosophy on study support                            tion actions. Although the effectiveness of these solutions is, in
                                                                     part, controlled by their functionality and flexibility, the train-
  Lastly, these emergent issues are applied to a case study of       ing experience itself can significantly impact the solution effec-
  Root Cause Analysis in bio-defense vaccine testing.                tiveness. Specifically, the quality and execution of the training
                                                                     can influence user acceptance, user efficiency, data quality,
           ADDED PHARMACEUTICAL CASE STUDY                           compliance process efficiency, and many other areas. Whether
                                                                     organizations utilize instructors from vendors, other third par-
  CASE STUDY                                                         ties, or use a train-the-trainer methodology, there are several
                                                                     key elements that must be considered in the training plan and
  4:30       TRENDING AND ANALYSIS OF DATA FROM                      execution. These elements and case examples will be provided.
             CAPA AND COMPLAINT SYSTEMS                              Participants will learn:
             Keith Scharringhausen, Senior Complaint Analyst           • Elements of a good training plan
             TAP PHARMACEUTICAL PRODUCTS INC.                          • Key success criteria and pitfalls in developing
                                                                         a training plan
   Trending and Analysis of CAPA and Complaint data is a criti-        • User profiling and training customization
  cal part of a GMP Quality program. Yet the best practices for        • Various training methods and results from case examples
  trending this data are often murky and undefined. With an            • Creative ways to reduce training costs and enhance
  understanding of the statistics that define the most commonly          learning retention
  used trending rules we can evaluate our curent practices and
  determine the best application and organization of this data for
                                                                     10:15 MID-MORNING BREAK
  routine and special trending and analysis.

    • Trending rules and statistics for CAPA and Complaint data
    • Examine common mistakes in setting up trending and
      analysis of this data
    • Evaluate best methods for analyzing this data and
      investigating potential trends

         REGISTER NOW! Call 813-655-7788 or email: or go to:                                        3
CASE STUDY                                                           requirements are considered in the presentation including
                                                                     structure, test development, use of vendor protocols, 21 CFR
10:30 STRATEGIES FOR SUCCESSFUL EVALUATION                           Part 11, network infrastructure qualification and Business
      OF A CAPA SYSTEM                                               Continuity Planning. The presenter will discuss different effi-
      Gregg Bell, Associate Director of Validation                   ciencies in the validation effort, impact and the pro's and con's
                                                                     associated with them. Lastly, the maintenance aspects of a vali-
                                                                     dated CAPA system in production will also be addressed, with
                                                                     recommendations to minimize impact and provide high service
This session will explore the primary criteria to be considered
                                                                     to the user community.
and evaluated for the selection of CAPA system and software
vendors, with a review of key elements of the selection process.
                                                                     CASE STUDY
Topics to be covered include:

  • Key elements of a Vendor Selection Process                       2:15    KEY SUCCESS FACTORS FOR
  • Vendor Selection Criteria and Evaluation                                 IMPLEMENTING A GLOBAL ELECTRONIC
  • Vendor Selection – Case Examples                                         QUALITY MANAGEMENT SYSTEM
                                                                             Steven R. Cagle, Vice President
CASE STUDY                                                                   SPARTA SYSTEMS, INC.

11:30 TURNING CAPA INTO PACA GLOBALLY:                               While most companies are implementing electronic methods
      THE MOVE FROM CORRECTIVE TOWARDS                                for managing data, those with foresight recognize that
      PREVENTIVE ACTION                                              implementing a QMS program requires key functional and
      Miguel Avila, Worldwide Director of Quality                    architectural capabilities to transform their tracking systems
                                                                     into proactive systems. This presentation will discuss key
                                                                     success factors for implementing an electronic Quality
                                                                     Management System across a global organization and address
                                                                     important aspects that go beyond basic CAPA tracking. The
This session will address the regulatory and business implica-       presenter will utilize actual customer case studies to highlight
tions of addressing corrective and preventive actions in order       lessons learned and best practices of implementing a global
to focus on potential problem detection and prevention. The          quality management system.
presentation will focus on the following areas:
                                                                     3:15    AFTERNOON BREAK
 •   Inputs and Triggers
 •   Six Sigma
                                                                     CASE STUDY
 •   Root Cause Analysis
 •   Risk Management
 •   Preventive Actions                                              3:30    DEVELOPING OR REFINING EFFECTIVE
                                                                             WORK FLOW PROCESS FOR A
12:15 LUNCHEON                                                               CAPA SYSTEM
                                                                             Sue Jacobs, President
                 TEN KEY FACTORS TO                                          QMS CONSULTING, INC.
                                                                     This session will discuss best practices for CAPA using recent
                                                                     FDA Warning Letter examples to emphasize key elements of
                                                                     the CAPA process. A detailed CAPA process work flow will be
                                                                     explained detailing the critical steps of the process.
         CAPA SYSTEM                                                  • Techniques for establishing action limits
         Mats Bergkvist, President                                    • When to use basic quality tools
         SDLS, CORP.                                                  • How to apply risk management
                                                                      • Closing CAPAs -- a two-step approach
The presentation will discuss experiences validating computer-        • How to conduct effectiveness checks
ized CAPA systems. The FDA validation requirements are                • Strategies for achieving regulatory compliance for
well-known and the process well-defined but the impact on the           CAPA documentation
organization is usually significant. The presentation will discuss    • Tips for monitoring the effectiveness your organizations
ten factors to expedite the validation effort and coordinate it         CAPA program
with the concurrent implementation effort. The end result will
be high end-user satisfaction and minimizing the overall project     4:30     CLOSE OF CONFERENCE
impact. All aspects of the CAPA systems impact and validation

     REGISTER NOW! Call 813-655-7788 or email: or go to:                                          4
                                                         CORRECTIVE AND PREVENTIVE ACTION
                                                                 September 25-26, 2006
    SWE ENTERPRISES, Inc.                                     Tremont Marriott • Boston, MA
    Pharmaceutical Conference Division
    PO Box 23202
    Tampa, FL 33623

                          TER by
                    REGIS 8th and
                    August ive a
                     $300 d

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