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.
How an effective PQS works end-to-end: management responsibility, resources, manufacturing operations, deviations, change control, audits, KPIs, CAPA and continual improvement.
نظام الجودة الدوائي — دورة فيديو تفاعلية بتعليق صوتي إنجليزي ونصوص ثنائية اللغة (إنجليزي / عربي).
Course modules
- Management Responsibility
- Resource Management
- Manufacturing Operations
- Evaluation I: Deviations, Changes and Audits
- Evaluation II: KPIs, CAPA and Improvement
Instructor: Rafat Alghubari — GxPeria Founder & MD.
For education only — always follow the official guidance and your site procedures.