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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)
Document Change Control
May 15, 2021

Top 5 issues with Document Change Control

QMS Document change control is resource intensive, time consuming, prone to audit findings, here are our top 5 findings. 1. For Document Change Control, approval...

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by Sanjay Dhalin Blog 0
Why do we need Quality Risk Management in QMS?
June 23, 2020

Why do we need Quality Risk Management in QMS?

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
21 CFR Part 11
February 13, 2020

Calibration and Asset Management in Bio-Med applications- Part11 Compliance

The Cal.ibration and Asset Management  is one of the key requirements for ISO9001, ISO13485 and other ISO standards. Effective Calibration Management is one of the...

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by Sanjay Dhalin Blog 0
February 13, 2020

How To Select a Better Calibration Software, Preventative Maintenance and Asset Management System

If you are running a Calibration, Preventative Maintenance Management, Asset Management operation with paper based or Excel spreadsheets, it may be taking lot of your...

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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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