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Slide 1 Good Documentation Practice The 1972 Devonport, UK, incident resulted in at least five deaths when drug products designed to be sterile became contaminated and recipients…

Documents Guidelines for Pharma Industry

Guidelines for Pharma Industry Pharmaceutical validation In pharmaceutical manufacturing industry Validation is very important part of Quality assurance and in Good manufacturing…

Health & Medicine Drug Utilization in a regulated Enviorment

1. Tracking drugs across the supply chain in a regulated environment. Alok Anand [email protected] 0091 9560639947 DRUG UTILIZATION ABSTRACT: Tracking drugs across the…

Health & Medicine Marketing Authorization procedures & premarket requirements sea countries

1. Marketing Authorization procedures & Premarketing requirements of Drug Product Registration in SEA countries Srinivasa Rao Moturi M.Pharm Regulatory Affairs Manager,…

Education Monograph devlopement manish

1. Prepared By, Manish Mudaliar M.Pharm, Semester-III Dept. of QARA LJ Institute of pharmacy 1 2. Indian Pharmacopoeia Commission (IPC) • Vision ▫ The IPC is committed…

Education pharmacopoeial standards

1. pharamacopoeial standardsRAGHAVA REDDY.KRATNAM INSTIUTE OF PHARMACYNELLOR EANDHRA PRADESH12/30/20101 2. Why we need standards ?How we can frame the standards ?What is…

Health & Medicine Drug Quality and Security Act

1. TAM13295 S.L.C. 113TH CONGRESS 1ST SESSION S. ll To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security,…

Documents FARM-Africa: a New Model of Livestock Services Delivery

1. FARM-AfricaOur strategyWork in 5 eastAfrican countries Scale up, share and disseminate3 areas of focusDevelop as models of good practicePastoral DevelopmentCommunity Forest…

Documents 1 Drug Quality in the 21 st Century Janet Woodcock, M.D. Director, Center for Drug Evaluation and...

Slide 11 Drug Quality in the 21 st Century Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research May 11, 2010 Slide 2 Background of FDAs Pharmaceutical Quality…

Documents FDA Compliance and Regulatory Symposium Understanding the FDAs Latest cGMP Guidances: Opportunities....

Slide 1FDA Compliance and Regulatory Symposium Understanding the FDAs Latest cGMP Guidances: Opportunities and Pitfalls Claudio Pincus, President, The Quantic Group R. Owen…