This specific ISBN edition is currently not available.View all copies of this ISBN edition:
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.
"synopsis" may belong to another edition of this title.
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.
"About this title" may belong to another edition of this title.
Book Description PDA/DHI. Hardcover. Condition: Good. 1930114818 Good++; Hardcover; Clean covers with minor edgewear; Covers have been fitted with green, genuine goat-leather corner protectors with gold accents; Pages are clean & unmarked; Good binding with a straight spine; This book will be stored and delivered in a sturdy cardboard box with foam padding; Medium Format (8.5" - 9.75" tall); White covers with title in blue lettering; 2005, PDA/DHI Publishing; 320 pages; "Quality Assurance Workbook for Pharmaceutical Manufacturers," by Michael Jahnke. Seller Inventory # SKU-S1004806085
Book Description PDA/DHI, 2005. Condition: UsedAcceptable. book. Seller Inventory # M1930114818_4