Part1-Sterility Assurance assessment considering EU Annex1(draft)

Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S. 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 [email protected] Disclaimer: This information has no link with Baxter or Baxter product/process or any information or anything that could identify company’s, colleague’s, vendor’s, patient’s, investor’s, or stakeholder’s personal information”.