CAPA - BulletProof Per ISO13485: 2016

This webinar shall provide insight of how to establish CAPAs that shall provide the organization the confidence that the organization is mature enough to handle its own failures and avoid future nonconformities.

Yuval Shapiro
Instructor:
Yuval Shapiro
Date:
Thursday, September 12, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 502722

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
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Overview:

FDA, EU Notified Bodies and other regulatory authorities investigate the capability of organizations to identify processes that require corrective and preventive actions.

Organizations should provide evidence that they have the required means and abilities to analyze failures and nonconformities, then set up corrections, corrective actions and corrective actions on duly manner.

This webinar shall provide insight of how to establish CAPAs that shall provide the organization the confidence that the organization is mature enough to handle its own failures and avoid future nonconformities.

Why should you Attend:

  • When CAPA is required
  • How to manage CAPA
  • The best approach to document
  • How to manage a CAPA

Areas Covered in the Session:
  • What are corrections, corrective actions and preventive actions
  • How to document CAPAs
  • Tools to identify root-causes
  • Pitfalls in managing CAPAs

Who Will Benefit:
  • Quality Manager
  • Quality Engineers
  • Engineering Managers
  • R&D Manager


Speaker Profile
Yuval Shapiro is the founder of QWV - Quality with Value, QA or RA Services. An expert for products and companies primarily related to medical devices that meet the real needs of their clientele. Substantial experience gained in various multi-discipline technology industries (Military, Telecom & Medical Devices), and give a high value contribution to quality and reliability projects related to the medical device and telecom industries.

More than 20 years of experience in QA; including MD and D RA and QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). More than 20 years of experience in QA; including MD&D RA & QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH and S Systems; QA or RA representative in R and D Projects. Risk Analysis as per ISO14791 & ISO31000. EMC & Safety Certifications.




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