Revised ICH Q9 (R1) Quality Risk Management Guideline | Jan 2023 скачать в хорошем качестве

Revised ICH Q9 (R1) Quality Risk Management Guideline | Jan 2023

ICH Published revised Q9 Guidance as Ver (R1) on 18-Jan-2023. This presentation is aimed at understanding this revised version specifically with reference to the changes. A detailed full explanation of concepts of Quality Risk management with practical example can be visited at: This revised version specifically has 4 major changes as below: 1. Formality in QRM approach 2. Risk based decision making 3. Minimizing subjectivity 4. Evaluation of risk related to Product availability & supply chain The tools of risk assessment like Failure mode effect analysis (FMEA), Failure mode effect & criticality analysis (FMECA), HACCP remains the same. This version also considers details related to State of control of manufacturing process, controls related to facility and equipment as well as control of outsourced activities. Your queries: Revised ICH Q9 guidance ICH Q9 updated guidance Quality Risk Assessment Risk Management ICH Guidelines ICH Quality Guidelines ICH Guidelines for Pharmaceuticals #ich #ICHGuidelines #ICHQ9 #riskmanagement About the Channel: The channel provides details of pharmaceutical guidelines, important updates on pharmaceuticals and other professional topics like interview preparation, personality development etc. Contact us at: [email protected]   / proftalks1680     / 13995930   Subscribe to our channel for more informative videos:    / @proftalks1680