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Complying with Part 11 - Risk Management
Complying with Part 11 - Risk Management
Complying with Part 11 - Risk Management
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.

Course Modules/Learning Objectives

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.
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.
Discounted member price: 400.00
Your price: 500.00
You could save 20.0%
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.

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.

ISPE CEUs: 1.20 ISPE CEUs will be awarded upon successful completion of grading requirements

Member Price: $ 400.00 / € 365.00
Non Member Price: $ 500.00 / € 440.00