21st Century Quality Management and Good Management Practices
21st Century quality management and good management practices is a practical guide on how to apply these 21st century principles in the pharmaceutical and biotechnology workplace and include simple understandable examples and case studies on modern compliance.
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Produktdetails
- ISBN: 978-1-907568-50-3
- EAN: 9781907568503
- Produktnummer: 13566241
- Verlag: Woodhead Pub
- Sprache: Englisch
- Erscheinungsjahr: 2011
- Seitenangabe: 250 S.
- Auflage: New.
Über den Autor
Steve Williams is Senior Partner and Director - International Education SeerPharma Pty Ltd, Australia. Steve has over 38 years experience in the biotechnology, pharmaceutical and medical device industries in quality assurance, manufacturing and consulting. He has conducted numerous FDA and EU/TGA/PICs compliance audits and gap analysis for many international companies as well as developed multiple training courses in GMP, GLP, validation, risk management, sterile manufacture, HACCP and medical device regulations. Steve regularly presents at conferences and industry seminars on a range of subjects relating to QA, risk management and GMP compliance. He also specialises in e-learning and compliance training solutions for the life sciences industry. Steve has successfully prepared multiple companies for FDA, EU, TGA, and PICS regulatory inspections over the last 20 years and has provided expert reports in GMP compliance for regulatory agencies and courts. He is also a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA) and, in this role, conducts GMP licensing audits on behalf of the Australian government.
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