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Quality Assurance Workbook for Pharmaceutical Manufacturers presents strategies for setting up and maintaining a quality management system that meets the rigors of regulatory compliance guidelines. This book shows you how your facility, through carefully planned processes, implemented at an early stage, can achieve and maintain a high production standard.
The book starts with management - outlining roles and defining responsibilities in quality assurance - and goes through the setup of contracts, documentation requirements, product identification and traceability, conducting self inspections and internal audits and, training.
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Michael Jahnke, PhD is Head of Quality Assurance at Wülfing Pharma GmbH, a contract manufacturer of sterile and non-sterile pharmaceutical drugs. He works on risk analysis in pharmaceutical drug manufacturing, hygienic risks caused by microorganisms and other topics in quality assurance. Dr Jahnke has achieved certification as a Specialist Microbiologist SM (AAM) Consumer and Industrial Microbiology - Pharmaceutical/Medical Device/Cosmetics. He is a member of the Parenteral Society and Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) and contributes to the Editorial Board of European Journal of Parenteral & Pharmaceutical Sciences of the Parenteral Society, UK and the Editorial Board of Journal of Pharmaceutical Science and Technology of PDA.
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Book Description PDA/DHI, 2005. Hardcover. Condition: New. book. Seller Inventory # M1930114818