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How CAPA and complaint handling should interact in Medical Device - Simplification of the processes is often needed to preserve their effectiveness

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This CAPA training/webinar for Medical device will guide you how CAPA and complaint handling should interact in Medical Device and it will mention the Differences between the FDA's approach and the ISO approach.

Speaker
Instructor: Nicolaas Besseling
Product ID: 701314
Training Level: Intermediate to Advanced

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:

Who will benefit:

This webinar aims to end some of the confusion around complaint handling and CAPA, and will benefit:

Instructor Profile:

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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Training Options Training Duration = 60 Min
$299.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$500.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days