QUALITY RISK MANAGEMENT AND IMPACT ASSESSMENT IN PHARMACEUTICAL

This two (2) days course will cover Quality risk management, and its assessment. Different assessment tool will be discussed and their implementations. Specific examples will be discussed on each tool. Impact assessment and its application. The relationship between risk assessment and impact assessment Reference: Annex 1 Manufacture of Sterile Medicinal Products 2023 ISPE Guide: Risk Based Manufacturing of Pharmaceutical Products ISPE Guide: Sterile Product Manufacturing PDA Technical Report No. 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems PIC/S PI038-2 1 January 2021 AIDE-MEMOIRE, Assessment Of Quality Risk Management Implementation WHO: Deviation Handling and Quality Risk Management ICH guideline Q9 on quality risk management, September ISPE Guide: Science and Risk-Based Approach for delivery of facilities, systems and equipment PDA Technical Report No. 54-6: Formalized Risk Assessment for excipients WHO Technical Report Series No. 981, 2013 Annex 2, WHO guidelines on quality risk management.

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