Introduction to Annex 11 Computer Qualification
Description
This Computer Qualification Annex 11, document applies to all forms of computerization used in connection with regulated activities, including process control, documentation control and data-processing systems. Computer Qualification Annex 11 also covers development, selection, validation and use of systems. For documentation, the requirements of GMP Chapter 4 shall also be considered.
Why should you participate
- At the end of this webinar, you will learn:
- What is the GMP Annex 11 for computerized systems guidelinesKey terminology fundamental for understanding Annex 11
- All forms of computerized systems used as part of GMP regulated activities this Annex 11 is applied to
- How to acheive compliance by walking through the detailed requirements of Annex 11 and exploring approaches and processe;
- How the requirements of Annex 11 are similar to Part 11, and where they differ.
Who should attend
- Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations
- Computer system vendors or consultants, engineering contractors, and validation service companies
Learning Objectives
- Annex 11 history and background
- Scope of Annex 11 – which companies must comply
- Annex 11 requirements and approaches for compliance
- Comparison of Annex 11 vs. Part 11
- Related guidance documents and standards
Education Approach
- The course sessions are illustrated with examples based on case studies
- Practical exercises include examples and discussions
