Data Integrity Part-II (Laboratory) Posted by By Palash Das December 22, 2015Posted inDrug regulatory and guidelines, QMS, Quality Assurance
Data Integrity -Part-I Posted by By Palash Das December 22, 2015Posted inDrug regulatory and guidelines, QMS
Management of Corrective and Preventive Action (CA-PA) Posted by By Palash Das November 30, 2015Posted inQMS, Quality Assurance
Discussion for establishment of risk based approach on airflow visualization in cleanrooms Posted by By Palash Das November 21, 2015Posted inValidation
Popular methods of Risk Assessment (Part-II) Posted by By Palash Das November 18, 2015Posted inQMS, Quality Assurance28 Comments
Popular methods of Risk Assessment (Part I) Posted by By Palash Das November 17, 2015Posted inQMS, Quality Assurance
Where should airflow velocity measurements be taken, with respect to a filling line or other aseptic processing areas? Posted by By Palash Das September 8, 2015Posted inValidation3 Comments
Application of near infrared spectroscopy to the analysis and fast quality assessment Posted by By Palash Das June 25, 2015Posted infnd and production
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