• 27/05/2021

Portfolio Description

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