Practical Application of Quality Risk Assessment Tools Training Course (PDA 531)

OVERVIEW

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

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:

• Fundamentals of Quality Risk Management Training Course (PDA 529)
• Any offerings of the prior PDA training courses, PDA 529/529.1 Technical Report No. 54: Foundations of Quality Risk Management or Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations

LEARNING OBJECTIVES

Upon completion of this event, the attendee will be able to:

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

WHO SHOULD ATTEND

This event is intended for professionals who apply quality risk management tools related to chemistry, manufacturing and controls, process development and process engineering and management.

RELATED EVENTS

Quality Risk Management Events