Corrective & Preventive Actions CAPA
Overview:
While the FDA understands that things don’t always go according to plan, they fully expect you to have a program that effectively resolves discrepancies and eliminates the possibility of recurrence (Corrective Action), as well as a program that identifies potential discrepancies/product problems and addresses them prospectively (Preventive Action).
This topic includes developing CAPA and deviation systems, root cause analysis and investigation documentation. In addition, best practices when handling recalls will be discussed, both in terms of internal systems and notifying and working with regulatory agencies. Examples/case studies include how to investigate a product problem, determining if a market withdrawal or recall is needed for the situation, and how to document the situation.
Instructional methods include: Lecture format, with questions/answers/discussion throughout.
How you will benefit:
By the end of the course, participants will gain the following:
- What corrective and preventive action, deviations, and investigations are
- What the regulatory requirements are
- How to document unexpected situations accurately and completely
The attendees will write their own corrective action plans and compare their ideas with the class.
Course Outline:
1) CAPA
- Why do I need a CAPA system?
- What makes a CAPA system effective?
- The CAPA Process
- The CAPA Form
- Records!
- Computer-assisted CAPA
2) Deviations and Investigations
- What is a deviation?
- Process deviations
- Floor redlines
- Validation failures
- What do I do about a deviation?
- What’s an effective investigation?
- How do I document my investigation?
3) Recalls
- What is a recall?
- What are corrections & removals?
- What do I do if I have to recall product?
Length of class: 3 - 4 hours, depending on amount of class participation
Who Should Attend:
Anyone who is involved in corrective/preventive action and/or recall activities: R&D personnel, manufacturing personnel, QA/RA personnel.