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Good Manufacturing Practices for Pharmaceuticals, Seventh Edition Details

Publisher
CRC Press; 7th edition
ISBN 13
9781032178387
ISBN 10
1032178388
Book Description
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.Key Features:Presents insight into the world of pharmaceutical quality systemsAnalyzes regulatory trends and expectationsIncludes approaches and practices used in the industry to comply with regulatory requirementsDiscusses recent worldwide supply chain issuesDelivers valuable information to a worldwide audience regarding the current GMP practices in the industry
About the Author
Graham P. Bunn is the president of GB Consulting LLC, in Pennsylvania, a company providing regulatory compliance, quality systems, regulatory action remediation, training and technical consulting services for pharmaceutical, biotechnology and other FDA and European Medicines Agency (EMA)-related industries. Before founding GB Consulting LLC, Graham experienced broad good manufacturing practices (GMP) and FDA inspection experience through his work in the pharmaceutical industry, including working for SmithKline Beecham PLC (GlaxoSmithKline PLC), Wyeth Pharmaceuticals (Pfizer), and Astra Merck Inc. (AstraZeneca PLC). His career experience includes management positions and responsibilities as a corporate quality auditor and in quality assurance, validation, and clinical trials manufacturing and packaging. He has developed and facilitated numerous highly interactive learning and training workshops worldwide. Graham is also the author of several book chapters and journal articles. A member of the Regulatory Affairs Professional Society (RAPS). Graham received a BSc in pharmacy from Brighton University, England, and an MSc in quality assurance and regulatory affairs from Temple University, in Philadelphia.
Language
English
Author
Graham P. Bunn
Publication Date
2021-09-30
Number of Pages
371 pages

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