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Investigations are an inevitable aspect of any manufacturer’s or wholesaler’s operations; while every company attempts to put in place a perfect systems and processes it is impossible to predict every potential failure mode and totally prevent incidents from happening This presentation, I will share some common issues that the inspectorate often sees during inspection at companies of all sizes and of all operating models, so you can consider your own company’s systems and practices and improve investigation outcomes. The concepts outlined in this post are equally applicable to deviations, customer complaints and several other Pharmaceutical Quality System (PQS) activities. Investigate a faulty Investigation ! (Part 1 ) • 483 or warning letter due to Inappropriate... This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc. Core Technical Skill: Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing Follow me, Read my blog Pharmaceutical resource and educational services at: https://pres.net.in/blog/ Follow me at LinkedIn : / palashchandradas Follow me at Twitter : / palash_das Follow me at Instagram: / pharmacistpalash Join Me, Admin and Member of "Global Federation of Pharmaceutical Industrial Association" Free joining link : / onlinepharma Share your queries and concern at mail2uscgmp@gmail.com