About Course
Manage changes the way modern regulators expect. This course places change management inside the Pharmaceutical Quality System (ICH Q10), clarifies what is in scope and how to handle grey areas, and shows how to classify changes using risk. You will follow the change process and its governance, carry out a structured impact assessment, plan the regulatory strategy for variations and post-approval changes (including ICH Q12), and decide what comparability and validation work is needed. Dedicated modules cover computerized systems, sector-specific considerations, and how to prove a change was effective and defend it during inspection. A final assessment and a certificate of completion are included.
Course Content
Module 1: Change Management in the Pharmaceutical Quality System
Module 2: Scope and Grey Areas
Module 3: Risk-Based Change Classification
Module 4: The Change Process and Governance
Module 5: Impact Assessment
Module 6: Regulatory Strategy for Changes
Module 7: Comparability and Validation
Module 8: Changes to Computerized Systems
Module 9: Sector-Specific Considerations
Module 10: Effectiveness Checks and Inspection Readiness
Final Assessment
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