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
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.

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: May-2009

Training CD / USB Drive

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CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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

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.

Follow us :
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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