ComplianceOnline

Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

Instructor: Jeff Kasoff
Product ID: 700322
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2017

Training CD

$349.00
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

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Read Frequently Asked Questions

This webinar will provide valuable assistance to all regulated companies; a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

Why Should You Attend:

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings.

This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Additionally, the application of risk management to a CAPA program will be reviewed, and a specific risk management system detailed.

This session will cover all the items listed above, and more. If you want to improve your CAPA system, you cannot afford to miss this.

Areas Covered in the Webinar:

  • Applicable Regulations, INCLUDING ISO13485:2016 CHANGES
  • Contents of Procedure(s)
  • Definitions
  • Quality Data and Recommended Practices for Inclusion in CAPA
  • Elements of a CAPA program
    • Detection of nonconformance
    • Identification of cause (Investigation)
    • Review of Investigation
    • Determination of Corrective/Preventive Action
    • Performance of Corrective/Preventive Action
    • Implementation of Corrective/Preventive Action
    • Effectiveness of Corrective Action
  • Summary

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies, a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • CAPA Coordinators
  • Executive Management
  • R&D management
  • Regulatory management
  • QA management
  • Consultants
  • Quality system auditors
Instructor Profile:
Jeff Kasoff

Jeff Kasoff
Director of Quality, Medivators

Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of site quality system compliance, including the CAPA program, and has established and overseen document control systems. Jeff is also the liaison with FDA and notified body auditors. In his previous position, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996, and his Quality Management Certification in 2013.

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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.

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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