To control risk, decisions must be made as part of the Quality Risk Management (QRM) process. Risk-based decision-making tends to be more dynamic and less structured than the other steps of the QRM process. A decision-maker’s role in the QRM process is critical for timely, effective and ongoing management of risks.
This training course will provide you with the ability to interpret the appropriateness and adequacy of risk control mechanisms. You will also explore the overall concepts of risk-based decision-making including risk tolerance, its impact on the success of risk management, and how to manage diversity in risk tolerance across your organization. This training course will strengthen learners’ competencies to identify and assess the results of a QRM exercise in order to enable robust risk-based decisions and enable success of QRM activities.
This training course is part of PDA's QRM Decision Maker 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.