This training course will cover the selection and application of various quality risk assessment tools. Different case studies from drug substance manufacturing, packaging, and labeling will be used to demonstrate appropriate selection and effective application of the various tools.
Attendees will also get hands-on practice with the more detailed and structured risk assessment tools - PHA, FMEA and FTA. In each of the application case studies, all stages of the QRM process will be covered including identification of risks, risk controls, estimating residual risks, practicing documentation and communication of outcome to management, and obtaining approval from decision makers.
Participants will also receive a free copy of:
- PDA Technical Report No. 54-2: Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling
- PDA Technical Report No. 54-4: Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances
This training course is part of PDA's QRM Application Track. Participants enrolling in this training course must have completed one of the following PDA training courses:
- PDA 529/529.1 Technical Report No. 54: Foundations of Quality Risk Management
- Any offerings of the prior PDA training course, Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
Additionally, participants should have read PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.