Change Control - Inspectors Expectations for GMP Compliance
- Essentials for SOP on Change Control
- Internal & external Changes
- PQS Interfaces
- EU requirements
- Change in Quality-Culture?
How to handle Changes in US
- 21 CFR 314.70
- Changes to an approved NDA and ANDA
- Examples (PAS, CBE, AR)
- Annual Report
- Comparability Protocol (US) vs. Change Management Protocol (EU)
Change Control Management; General Points to Consider: How to manage it, who‘s involved and when does it apply
- Identification and classification of changes
- Risk and impact analysis of changes
- Change control as management tool
- Management of changes with suppliers and contractors
Interactive Session: How to implement a comprehensible Change Control System in your Company
- EU Variation Procedure
- Change Control Handbook
- SOPs
- Change Control Protocol
- Forms
with practical advice how to implement and use them
What’s a Change and how to proceed
- Technical changes: Change Control or not
- How to deal with software updates
- Risk Analysis in Change Control
- Classification of Changes
- How to document changes
Change Control in the context of Product Lifecycle Management:
- Product Development Strategies and Change Control
- Post Approval Change Management/ Comparability Protocols / Established Conditions (ECs)
- ICH Q 12 Product Lifecycle Management
Workshops
Interactive exercises to examine and evaluate some real examples of various changes:
- Manufacturing process
- Cleaning process
- Analytical process
- Microbiological testing
- IMPD
- Manufacturer’s Authorisation