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Recorded Webinar

FDA Medical Device Regulation – Effective Corrective and Preventive Action Processes

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

While the FDA and ISO auditors understand that things don’t always go according to plan, they expect you to have a program that effectively resolves nonconformances and eliminates the possibility of recurrence (Corrective Action), as well as a program that identifies potential nonconformances/product problems and addresses them prospectively (Preventive Action). The CAPA process is the heart of your quality system, provides insight into how effective your quality system is, and it is part of every regulatory inspection or audit.

This one-hour overview covers the FDA’s CAPA regulations, how to develop an effective CAPA system, and how to document root cause analysis and investigations.

The presentation will cover the following areas:

  • Why do I need a CAPA system?
  • What makes a CAPA system effective?
  • The CAPA Process
  • CAPA Forms and Records
  • Common CAPA Pitfalls
  • Computer-assisted CAPA


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