This CAPA session will discuss these common pitfalls and share best practices, strategies and techniques on how to deal with CAPA system in relation to Warning Letters and 483 citations. In 2005 greater than 50% of FDA Warning Letters and 483 citations were CAPA related.
Many firms face similar challenges; aging CAPAs, failed effectiveness checks, an inadequate procedure, an ineffective method for prioritization, CAPA system too complex, and lack of management support. This session will discuss these common pitfalls and share best practices, strategies and techniques on how to deal with them.
What Attendees will Learn:
FDA Inspection trends related to CAPA,
Common CAPA pitfalls and how to avoid them,
How to overcome conflicting priorities and competing resources,
How to deal with aging CAPAs,
Why effectiveness checks fail and what to do about it,
Tips on how to escalate issues for management support,
Integrating risk management to leverage positive results,
Unique challenges and expectation for global manufacturers.
Many firms face similar challenges; aging CAPAs, failed effectiveness checks, an inadequate procedure, an ineffective method for prioritization, CAPA system too complex, and lack of management support. This session will discuss these common pitfalls and share best practices, strategies and techniques on how to deal with them.
What Attendees will Learn:
FDA Inspection trends related to CAPA,
Common CAPA pitfalls and how to avoid them,
How to overcome conflicting priorities and competing resources,
How to deal with aging CAPAs,
Why effectiveness checks fail and what to do about it,
Tips on how to escalate issues for management support,
Integrating risk management to leverage positive results,
Unique challenges and expectation for global manufacturers.
Who Will Benefit:
- CAPA Managers
- Quality professionals
- Regulatory professionals
- Operations and Engineering personnel
Course Provider
Sue Jacobs,
