Complying with Part 11 - Risk Management: Applying the GAMP® Good Practice Guide Electronic Records and Signatures Principles (T08)
Using the GAMP® Guide: Records and Data Integrity as a resource, this course will give participants a practical introduction to the 21 CFR Part 11 regulation, which affects all aspects of computerized systems in the pharmaceutical industry and up-to-the-minute information on current FDA interpretations. Taught through classroom presentations, workshop sessions, and team exercises, the course will present an overview of Part 11 including its objectives, benefits, and potential problems. This will be followed by a detailed analysis of Part 11 requirements, a discussion of electronic records and signatures, and key industry issues.
Updates to this course include:
- Recently announced FDA Part 11 Inspection Assignments
- EU regulatory expectations as reflected in the draft revised Annex 11
- This course is also available online: Online Course: Complying with Part 11 – Risk Management
What You Will Learn
A central element of this training course will be an explanation of the GAMP approach to 21 CFR Part 11 compliance, as well as compliance with other international regulations covering electronic records and signatures. The GAMP Records and Data Integrity Guide provides timely and much needed direction on meeting current 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.
Resources and Activities
- Pre-Course Work Materials
- Interactive Exercises
- Learning Assessments
- ISPE GAMP Guide: Records and Data Integrity
- Background to 21 CFR Part 11
- Final Guidance
- Current FDA Interpretation
- Requirements of 21 CFR Part 11
- 21 CFR Part 11 Practical Examples
- GAMP Records and Data Integrity Guide
- Examples of the Application of Risk Management Principles
- International ER&S Regulations and Guidelines
- Revised EU Annex 11 and Chapter 4 - EU expectations for ER&S
- 21 CFR Part 11 Definitions
Who Should Attend
- 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.
Additional Course Details:
- Interpret the 21 CFR Part 11 regulation
- Be prepared for Part 11 inspections
- Discuss international regulatory expectations for use and control of electronic records and signatures in computer systems used in the pharmaceutical and related life sciences industries
- Apply Part 11 to specific systems and cases
- Describe the GAMP risk management approach to Part 11 compliance
- Understand Part 11 key issues
- Apply lessons learned to systems within their own organizations
Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE GAMP® Community of Practice (COP).