Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production скачать в хорошем качестве

Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production

This presentation will guide you how to gained knowledge and flow of investigation for OOS. 1. Out of Specification Guidance- https://mhrainspectorate.blog.gov.uk/... 2. Out-of-specification investigations- https://www.gov.uk/government/publica... 3. Investigating Out-of-Specification Test Results for Pharmaceutical Production- https://www.fda.gov/regulatory-inform... 4. Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production https://www.fda.gov/media/71001/download 5. OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT- edqm.eu/sites/default/files/medias/fichiers/OMCL_Network/Find_information_on/Quality_Management_Documents/omcl_evaluation_and_reporting_of_results_-_annex_1a_model_template_for_failure_investigation_of_oos_results.pdf 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]