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Complying with Part 11 - Risk Management: Applying the GAMP®
Complying with Part 11 - Risk Management: Applying the GAMP®
Complying with Part 11 - Risk Management: Applying the GAMP® Good Practice Guide Electronic Records and Signatures Principles

Applying the GAMP® Good Practice Guide: A Risk Based Approach to Compliant Electronic Records and Signatures as a resource, this course will give participants a practical introduction to the 21 CFR Part 11 regulations, which affects many aspects of computerized systems in the pharmaceutical industry.

The course will present an overview of Part 11 expectations including FDA's current interpretation.This will be followed by a detailed analysis of Part 11 requirements, a discussion of electronic records and signatures, and key industry issues.

The recently revised EU GMP Annex 11 and Chapter 4 (which have been adopted for international use by PIC/S) are also covered. As well as the European and international expectations for electronic records and signatures, the general requirements for computer systems validation and compliance as described in Annex 11 will be explained in detail.

A central element of this course will be the GAMP risk management based approach. The GAMP Good Practice Guide provides timely and much needed direction on meeting regulatory expectations for compliant electronic records and signatures. The Guide describes how a risk management approach may be used to ensure the compliance of regulated electronic records and signatures, through the application of appropriate controls commensurate with the impact of records and the risks to those records.

Approximate Course Duration:

2 Days (this is a self-paced course)
NOTE* You will have 14 calendar days to access and complete this course from time of purchase.

Immediately apply the course learning objectives with pre and post assessments, downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all web links discussed.

Module 1 FDA Guidance Part 11 Scope and Application
  • Understand the FDA interpretation of 21 CRF part 11 as defined in the Scope and Application Guidance.
  • Explain the concept of narrow scope.
  • Provide an overview of the nature and role of predicate rules.
  • Module 2 European Requirements Annex 11 and Chapter 4
  • Complete an overview of European and International requirements for electronic documentation.
  • Review detailed requirements for revised EU GMP Annex 11 on Computerized Systems.
  • Outline European and international expectations for electronic signatures.
  • Module 3 The Requirements of 21 CFR Part 11 Records, Subpart A and B
  • Review FDA’s intentions and objectives for Electronic Recordkeeping.
  • Recognize the Scope and Key Concepts of Part 11.
  • Understand the detailed requirements for Electronic Records.
  • Module 4 The Requirements of 21 CFR Part 11 Records, Subpart C
  • Review the general provisions of 21 CFR Part 11.
  • Understand the detailed Part 11 requirements for electronic signatures.
  • Understand good practice for applying electronic signatures.
  • Module 5 A Risk Management Approach to Compliant Electronic Records and Signatures
  • Gain an overview of the GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.
  • Understand the five step process described in the guide.
  • Review what a risk-based approach means in practice.
  • Attendance Suggested for:
  • Quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, MIS professionals.
  • All levels of management who need a fundamental understanding of the 21 CFR Part 11 regulation, and risk management approaches to achieving electronic record and signature compliance.
  • Community of Practice (COP)
  • This training course is of particular interest to existing and future members of the ISPE GAMP Community of Practice (COP).

  • Instructor Biography

    Sion Wyn is an acknowledged expert in computer system validation and compliance and international regulations in this field. He assisted the FDA with its re-examination of 21 CFR Part 11, and is a member of the team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He is the technical content expert for the FDA's ORA Virtual University on-line training modules on computerized systems validation and compliance. He has 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 Council, GAMP Editorial Board, and the GAMP Europe Steering Committee. He has extensive experience in all aspects of computer systems validation and compliance, including managing validation projects, validation planning, specification and testing of systems, performing site and system compliance audits, writing SOPs, performing 21 CFR Part 11 assessments, and supplier audits. Wyn's expertise as a specialized computer validation consultant covers all stages of the lifecycle approach to validation of computerized systems and most system types including ERP, manufacturing execution, electronic document management, EBRS, process control and monitoring, environmental monitoring, manufacturing equipment, and laboratory systems. At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated life-science industries. Wyn received the 2006 ISPE Professional Achievement Award, which honors an ISPE Member who has made a significant contribution to the pharmaceutical manufacturing industry.

    Continuing Education Credits:

    After successful completionof this course the student will be awarded 1.30 CEU's

    Discounted member price: 600.00
    Your price: 700.00
    You could save 14.3%

    Member Price: $ 600.00 / € 465.00
    Non Member Price: $ 700.00 / € 540.00

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