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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)
June 30, 2023

Corrective and Preventative Action (CAPA) Software

It is challenging to manually manage Corrective and Preventative Action (CAPA) process with paper based or Excel file system. Here are some of the key...

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by Sanjay Dhalin Blog 0
Design control of Medical Device
May 29, 2023

What is Design Control of Medical Devices

The Design Control of Medical Devices includes but not limited to creation, change and reviews of design data, including but not limited to, design input...

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by Sanjay Dhalin Blog 0
December 25, 2022

Medical Device Quality Risk Management

https://www.slideshare.net/SanjayDhal/risk-management-in-qms-and-new-products-design-npd   By adding quality risk management into your processes, especially at the design and planning phase, you can take actions to ensure that anticipated...

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by Sanjay Dhalin Blog 0
QMS Software Pharma
March 19, 2022

Top 10 Factors for Selecting QMS Software for Pharma Companies

TOP 10 FACTORS TO CONSIDER FOR SELECTINGQMS SoftwareFor Pharma and Life Science CompaniesThere are many challenges involved when selecting and implementing a Quality Management System...

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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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