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21 CFR Part 11 an Industry Perspective
21 CFR Part 11 an Industry Perspective
21 CFR Part 11 an Industry Perspective
Industry experts discuss current inspection findings, expectations for GMP and quality systems, the quality of the supply chain by adequate qualification of vendors and contract manufacturers, expectations of management, and CDERs Part 11 inspectional assignments. At the conclusion of this course, participants will be able to:
  • Understand the need for record integrity and controls
  • Understand GAMP Guidance - practical tools and help
  • Understand how to prepare for Part 11 inspection

  • Speaker Biography
    Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations in this field. At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated life-science industries. He assisted the FDA with its re-examination of 21 CFR Part 11, and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He was the technical content expert for the FDA's ORA Virtual University on-line training modules on computerized systems validation and compliance. He received the FDA Group Recognition Award for work on Part 11. Wyn is the editor of ISPE's GAMP5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, and is a member of the ISPE GAMP Global Steering Committee, GAMP Editorial Board, and the GAMP Europe Steering Committee. Wyn is the lead GAMP and Part 11 trainer and course developer for ISPE and has extensive experience in all aspects of computer systems validation and compliance. Wyn received the 2006 ISPE Professional Achievement Award, which honors an ISPE Member who has made a significant contribution to the pharmaceutical manufacturing industry.

    Discounted member price: 49.00
    Your price: 149.00
    You could save 67.1%
    This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

    ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

    Approximate Course Duration: 60 minutes (this is a self-paced course)

    *NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

    ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 49.00 / € 45.00
    Non Member Price: $ 149.00 / € 136.00

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