ComplianceOnline

CAPA systems in Post Marketing Surveillance

Instructor: Marta L Villarraga
Product ID: 700451
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
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

Customer Care

Fax: +1-650-565-8542

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Read Frequently Asked Questions

This CAPA systems webinar will guide you through the role of Corrective and Preventive Actions (CAPA) systems will be discussed within the context of risk management practices.

The FDA’s Investigations Operations Manual (2006) notes: "How firms identify the causes of medical device recalls and corrective action activities is essential to the analysis of medical device failures and the determination of the effectiveness of the medical device GMP program."In the context of post-marketing surveillance, internal preparations for a recall need to be on your immediate list of concerns. Recalls can be very disruptive to a company, but preparation in advance can make a significant difference in minimizing this disruption. The FDA’s Investigations Operations Manual (2006) notes: "How firms identify the causes of medical device recalls and corrective action activities is essential to the analysis of medical device failures and the determination of the effectiveness of the medical device GMP program." The role of Corrective and Preventive Actions (CAPA) systems will be discussed within the context of risk management practices.

Areas Covered in the seminar:

  • Why are CAPA systems important?
  • What role do they have within risk management?
  • How do CAPA programs play a role in potential or ongoing recalls

Who will benefit:

This presentation will provide an overview of Corrective and Preventive Actions (CAPA) systems and give a review of what FDA inspectors are looking for when they review CAPA systems. The focus will be on how to identify existing and potential problems. The employees who will benefit include:

  • Engineering staff in design and manufacturing
  • Health professionals who interface with physician or patient users
  • QA managers and personnel
  • Regulatory Affairs managers and personnel

Instructor Profile:

Marta L. Villarraga, Ph.D. is a Principal Engineer at Exponent, Inc, a scientific and engineering consulting firm. Dr. Villarraga concentrates her practice in failure analysis of medical devices in the areas of product liability, intellectual property, regulatory compliance, quality control and manufacturing compliance. She has assisted companies with root cause analyses prior to a recall or as part of the investigation following a recall being announced. Dr. Villarraga is also a reviewer for various scientific journals. She has also published a number of scientific articles and frequently presents at national conferences. She recently contributed to various chapters in the book "Bringing your Medical Device to Market," including one on medical device recalls. She also holds adjunct faculty appointments at various local and regional universities where she often lectures.

Follow us :
ComplianceOnline Medical Device Summit 2017
FDA's New Import Program for 2017 - Strict Precision

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.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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