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Drug regulatory and guidelines

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Data Integrity (Part-III) (Some Major Observations)

Posted by By Palash Das December 23, 2015Posted inDrug regulatory and guidelines, QMS, Quality Assurance
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Data Integrity Part-II (Laboratory)

Posted by By Palash Das December 22, 2015Posted inDrug regulatory and guidelines, QMS, Quality Assurance
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Data Integrity -Part-I

Posted by By Palash Das December 22, 2015Posted inDrug regulatory and guidelines, QMS
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Regulatory expectation and guidance on Pharmaceutical market complaints

Posted by By Palash Das October 29, 2015Posted inDrug regulatory and guidelines
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When the FDA Inspector visits your firm, What are the Chances of a Really Bad Outcome?

Posted by By Palash Das May 24, 2015Posted inDrug regulatory and guidelines
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Major USFDA warning Letters observation from 2000

Posted by By Palash Das February 5, 2015Posted inDrug regulatory and guidelines, News Updates
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Selection of Glass Vial Sterile Injectable product

Posted by By Palash Das March 21, 2014Posted inDrug regulatory and guidelines, News Updates
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Guidance to Qualification and Validation towards Global Pharmaceutical Practice

Posted by By Palash Das November 7, 2013Posted inDrug regulatory and guidelines, Quality Assurance, Validation
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CFR – Code of Federal Regulations Title 21

Posted by By Palash Das August 17, 2013Posted inDrug regulatory and guidelines, Quality Assurance
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Guidelines for viable & non -viable counts in gmp areas (As per WHO,2011)

Posted by By Palash Das April 24, 2013Posted inDrug regulatory and guidelines, News Updates, Quality Assurance, Validation
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