In House Training Course

Effective investigation and CAPA

(0.5 Day)

Who will benefit from this training : Production Staff / Chemists / QC Lab staff / QA

Introductions

Why must we investigate? 

What must we investigate?           (The role of CAPA in Continuous Improvement)

What are FDA/ MHRA looking for?

Examples of Investigative techniques

              Kepner Tregoe (Problem Solving)

              Five Whys (? ? ? ? ?)

What needs to be documented in an investigation and why?

Methods of gathering information (why and how) e.g. interviewing personnel, reviewing batch documentation

Assessing the impact on other areas, processes etc  - why and how

Importance of closing out investigations / implementing CAPA in a timely manner

Coffee / Tea

Workshop:

•  Production
• Laboratories

 Avoiding Typical Shortcomings

Why put effort into CAPAs?

What goes wrong with investigations?

Avoiding CAPA pitfalls

Q&A

Roundup / Summary

This training could be used in conjunction with other courses available, please contact us if you would like help in putting a programme together

Course Speaker

Dr David Inglis