In House Training Course

CAPA in the Pharmaceutical Industry

Programme for One-Day Seminar

Introductions and Outline of Programme

Basic understanding of CAPAs

• Where / when are CAPAs required?
• FDA / 21CFR requirements for CAPAs and CAPA management (21CFR Part 820.100)

Common misconceptions about CAPAs

Coffee/Tea Break

Workshop

• Sources of data (trending, etc)
• Classification the Severity of the deviation or incident

Principles of Critical Deviation Management (CDM)

Lunch

FDA inspection of CAPA sub-system

Workshop:

• Practical management of CDM
• CAPAs from complaints / returns / recalls

Coffee/Tea Break

How to Avoid Too Many CAPAs (applications of Risk Assessment)

Responsibilities, Tracking and Close Out of CAPAs

Questions and Answers

N.B.        This course runs two workshops in parallel at each “Workshop” session. 

There are two more workshops available (API Production and Laboratories).  If these are added and all six workshops are included in series, this can be run as a highly “practice-orientated” two-day course.

Speaker

Dr David Inglis