This training course will cover the application of various quality risk assessment tools and considerations for tool selection. Different case studies from drug substance manufacturing and packaging and labeling will be used to demonstrate 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.
This training course is part of PDA's QRM Application Track. For more information on PDA's QRM Certificate Program, please visit the "PDA Quality Risk Management Training Courses" page below.
Participants enrolling in this training course must have completed one of the following PDA training courses:
- 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 (TR 54): Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.