PDA 531.1 Technical Report No. 54-2 and 54-4: Practical Application of Quality Risk Assessment Tools

This live eLearning 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 exposure to a variety of methods with an in-depth discussion into the more structured risk assessment tools – PHA, FMEA, and FTA. The class attendees will be assigned to small, virtual teams to gain hands-on practice with the tools. 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. The teams will share back to the class the key learnings to reinforce the content.

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

PREREQUISITES

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.

1. Apply the formality spectrum concept for risk assessment tools
2. Explain why and how tool selection is important in ensuring the right outcomes and decisions from a QRM application
3. Examine considerations when selecting the appropriate risk assessment tool
4. Demonstrate where and how application of simple risk assessment tools such as checklists, simple decision trees, technical assessments etc. can be used as alternatives to more detailed risk assessment tools such as PHA, FMEA, FTA
5. Use structured risk assessment tools such as PHA, FMEA and FTA