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Author: Sanjay Dhal

Quality and Regulatory Management Professional with more than 20 years experience in Quality System, Quality Engineering, Supplier Quality Management, Regulatory Compliance and Operational Excellence in the Life Science industry. Strong knowledge and expertise in the FDA Regulations including 21 CFR 820, 21 CFR 210, 21 CFR 211, 21 CFR Part 11 compliance requirements. Sanjay has been a trusted advisor for many Medical Technology and Life Science companies. Sanjay is a recognized leader in the QMS area and holds following certifications from American Society of Quality (ASQ). * Certified Six Sigma Black Belt (CSSBB), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA)
February 13, 2020

Simple Guide for Corrective and Preventative Action (CAPA)

The following section describes a sample SOP (standard operating procedure) for corrective and preventive actions (CAPA) in your Quality Management System (QMS). Please contact us...

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by Sanjay Dhalin Blog 0
February 12, 2020

Simple Guide for ISO13485 Auditing

This document provides simple guidance and details you would need to set up your internal auditing process to comply with the ISO13485 standard and FDA...

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by Sanjay Dhalin Blog 0

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Recent Posts

  • Corrective and Preventative Action (CAPA) Software June 30, 2023
  • What is Design Control of Medical Devices May 29, 2023
  • Medical Device Quality Risk Management December 25, 2022
  • QMS Software for ISO13485 December 24, 2022
  • Top 10 Factors for Selecting QMS Software for Pharma Companies March 19, 2022

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