PDA West Chapter is offering a hands-on workshop that gives you ample time to practice what you learn and will cover the following topics:
- Examples of Sources of Failures
- FDA Expectations for Investigations
- Documentation Guidelines
- Writing Deviations – Problem Definition/Impact Assessment (Risks/Liabilities)/Material Disposition
- Group Activity - Break into groups to write an effective problem definition and do Impact Assessment (topics to be given will include API issue, Drug product issue, temperature excursion, labeling issue, shipping issue, complaints
- Performing Root Cause Analysis - Review different methods for RCA (5 Whys, Fishbone/FMEA Analysis/Brainstorming, Pareto Charts/Trend Charts)-Spokesperson for each group to present their work to the audience for critique/improvement.
- Group Activity - Continue with the problem definition to do a RCA- Spokesperson for each group to present their work to the audience for critique/improvement.
- Developing an effective CAPA plan for the same scenario above
- Group Activity-Continue with the investigation to do a CAPA- Spokesperson for each group to present their work to the audience for critique/improvement.
After the completion of this course, you will be able to:
- Improve your ability to write a clear, concise deviation report
- Perform a thorough investigation
- Write an effective CAPA plan
- Minimize regulatory liability by appropriately documenting findings
- Enhance your understanding of what the FDA expects to see from a deviation/CAPA reporting system