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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)
QMS Software Pharma
March 19, 2022

Top 10 Factors for Selecting QMS Software for Pharma Companies

TOP 10 FACTORS TO CONSIDER FOR SELECTING QMS Software For Pharma and Life Science Companies There are many challenges involved when selecting and implementing a...

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by Sanjay Dhalin Blog 0
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

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Recent Posts

  • Top 10 Factors for Selecting QMS Software for Pharma Companies March 19, 2022
  • Top 10 Factors for Selecting QMS Software for Medical Device September 24, 2021
  • Top 5 issues with Document Change Control May 15, 2021
  • Supplier Quality Management – How to do this? August 16, 2020
  • Internal Audit Management, Policy and Procedure July 29, 2020

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