Ensure Compliance and Quality in Medical Device Manufacturing
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CAPA in the Medical Device Industry
Length of Course
1 Day
Deliver Method
Classroom
Materials
Each participant will receive a training manual
Certificate of Completion
A certificate of completion will be issued on successful course completion.
Level of Difficulty
Beginner (no knowledge at all of the topic).
Corrective and Preventive Action (CAPA) continues to be one of the top two causes of 483s from the FDA. One of the main causes of companies receiving a CAPA 483 from the FDA is failure by the company to fully understand the FDA’s expectations of a well run CAPA system. This course provides delegates with a comprehensive understanding of the FDAs expectations while also explaining the European requirements for CAPA.
By attending this course delegates will obtain the tools and skills necessary to implement a CAPA system that not alone meets FDA and European requirements, but also brings about real improvement in the company’s product and Quality System performance. Practical exercises will be completed throughout the day covering real life situations so that delegates can be confident of implementing CAPA requirements to the FDA’s satisfaction when they return to the workplace.
The course covers the Seven CAPA Steps approach to fulfilling the CAPA related requirements of 21 CFR part 820, 21 CFR Part 211, ISO 13485, ICH Q10 and, FDA and European Guidance Documents.
On completion of this training, participants will be able to:
- Implement the Seven CAPA Steps approach.
- Meet FDA and European expectations when completing CAPAs.
- Conduct thorough Investigations into the causes of failure.
- Distinguish between Correction and Corrective Action.
- Distinguish between Corrective Action and Preventive Action.
- Generate Corrective Actions that truly address the Root Causes of failure.
- Write SMART Effectiveness Checks criteria.
- Assess the Effectiveness of Corrective Actions.
- Assess the Overall Effectiveness of a CAPA system
Personnel in the Pharmaceutical/Medical Device/Healthcare sectors involved in any part of a CAPA system; these may include Operators, Technical Staff and Management from Production, Quality, Engineering or Support Functions.