Mr.Yuval Shapiro

Area Of Expertise : QA/RA /Quality Management Systems, Production Process Validations, Cost of Quality, EU 2017/745 MDR
27 Years Of Experience
Training Industry : Life Sciences

Quality Assurance & Regulatory Affairs Expert for products and companies primarily related to medical devices and telecom that meet the real needs of their clientele. Substantial experience gained in various multi-discipline technology industries (Medical Devices, Telecom & Military), and give a high-value contribution to quality and reliability projects related to the medical device and telecom industries.More than 25 years of experience in QA; including MD&D RA & QA (EU-MDD/MDR, 510k);QMS (21CFR - Part820, ISO13485, MDSAP, TL9000, ISO9001). EH&S Systems; QA/RA representative in R&D Projects; Risk Analysis as per ISO14791& ISO31000; EMC & Safety Certifications Supply Chain QA & Supplier QA; CAPA; Training; Six Sigma; Process Validation; 5S and Lean Production; Configuration Control.

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Recorded Webinar

Bulletproof CAPA Process: How to do it Right?

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 t ...

  • Basic & Intermediate
  • 60 Mins