How CAPA and complaint handling should interact in Medical Device - Simplification of the processes is often needed to preserve their effectiveness
Instructor:
Nicolaas Besseling
Product ID: 701314
Training Level: Intermediate to Advanced
- Duration: 60 Min
FACT: Corrective and Preventive Action (CAPA) is one of the areas cited most frequently in FDA's observation reports (483's) and warning letters. Many companies have deficiencies in both procedures and execution. One reason is that CAPA and complaint handling are interwoven, complex areas that need to be thought out and codified carefully. If a company's (quality) management does not fully understand the intricacies involved, chances are that either one or both of those processes quickly will become non-compliant. Unneeded complexity of the SOP's governing these areas can have a negative impact on the effectiveness of the CAPA and complaint handling processes.
Every medical device company must have procedures in place for complaint handling and corrective and preventive action (CAPA). CAPA and Complaint Handling are discussed in relation to one another and when to use one versus the other. The documentation requirements will be discussed. Differences between the FDA's approach and the ISO approach are mentioned.
Areas Covered in the seminar:
- Complaint handling: flow chart and requirements.
- What feeds CAPA?
- How complaints and CAPA interact.
- Service operations and complaints/CAPA.
- CAPA responsibilities.
- CAPA documentation trail.
- Manual or computerized systems?
- Complexity is the enemy.
Who will benefit:
This webinar aims to end some of the confusion around complaint handling and CAPA, and will benefit:
- Regulatory and QA managers and personnel
- Test and Service managers and personnel
- IT managers of companies with automated systems
- Senior management
Nicolaas Besseling,, MSEE, is the founder and President of BesTech Consulting Services, specializing in Quality Systems and Regulatory Affairs for medical device companies. Mr. Besseling has over 35 years experience in the medical device industry, as design manager and regulatory specialist. He implements quality systems, using standard operating procedures (SOP's) that he has developed over years of working with small and medium sized companies. He also specializes in risk management and design control.
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