Setting up a QSR Compliant CAPA System

Speaker

Instructor: Sue Jacobs
Product ID: 700130
Training Level: Advanced

Location
  • Duration: 60 Min
In this CAPA training learn how to utilizing multiple data sources to detect actual and potential nonconformities.
RECORDED TRAINING

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$500.00
1 USB is for usage in one location only. info CD/USB and Ref. material will be shipped within 15 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

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Read Frequently Asked Questions

Establishing a CAPA system is a requirement of the FDA quality system regulation for medical devices. This Webinar will discuss the key elements of an effective CAPA system, what needs to be addressed in written procedures, and CAPA documentation.

What Attendees will Learn

  • What are the elements of an effective CAPA system,
  • Understand the difference between corrective action and preventive action,
  • Strategies to analyze multiple data sources to identify product, process and quality system problems,
  • Techniques to establish action limits for CAPA,
  • When to use basic quality tools,
  • Strategies for achieving regulatory compliance for CAPA documentation.

Who Will Benefit:

  • CAPA Managers
  • Quality professionals
  • Regulatory professionals
  • Operations and Engineering personnel

Instructor Profile:

Sue Jacobs, is the Principal Consultant for QMS Consulting, Inc. specializes in US FDA compliance with medical device quality and regulatory requirements. Ms. Jacobs has more than 19 years experience in the medical device industry. She assists manufacturers and suppliers in developing and maintaining compliant quality system programs. She has served as a quality system expert witness on behalf of the US Food and Drug Administration. Ms. Jacobs is serving on the Board of Directors for the American Society for Quality (ASQ). She participated in FDA/Industry Grassroots Task Force meetings which implemented the program to pre-announce FDA inspections, annotate FDA Form 483s, and send close out letters after inspections. She also was a member of the Advisory Committee that wrote AdvaMed’s Points to Consider When Preparing for a QSIT Inspection. Ms. Jacobs is a member of the Regulatory Affairs Professional Society (RAPS), faculty member for AAMI’s GMP and Industry Practice Course and frequent speaker at educational programs for AdvaMed MTLI, MD&M, FOI Services and Management Forum Ltd.

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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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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