Featuring PIC/S GMP Fundamentals in vivid comparison with WHO-GMP
【Lecture-1】 PIC/S Fundamentals and comparison with WHO-GMP
【Lecture-2】 Principles of Pharmaceutical Quality System (PQS)
【Lecture-3】 Principles of PQS – the concept of Quality-by-Design (QbD)
【Lecture-4】 EU-GMP Annex 15 – a new concept of validation
【Lecture-5】 Documentation for Qualification
【Lecture-6】 Lean Commissioning and Qualification – an innovative execution management
【Workshop】 “PQS Activities” – Quality Risk Management (QRM), Corrective Action &
Preventive Action (CAPA), Out-of-Specification (OOS) and Management Review
【Lecture-7】 Preparation for PIC/S Inspection
Panel Discussion
