Managing Quality In Biotechnology - Goldenthal, Allen E.
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Managing Quality in Biotechnology is unique in its approach to Total Quality Management (TQM) as it adopts an insider's view of what is crucial and important in the day-to-day operations of bio-related laboratories at both an academic research level as well as by a full production facility. Most reference books on TQM have been written specifically for the commercial production facility and have not addressed that quality must begin at inception of the initial concept and that relies on it being implemented all the way back to the primary investigator in his university or company laboratory.…mehr

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Produktbeschreibung
Managing Quality in Biotechnology is unique in its approach to Total Quality Management (TQM) as it adopts an insider's view of what is crucial and important in the day-to-day operations of bio-related laboratories at both an academic research level as well as by a full production facility. Most reference books on TQM have been written specifically for the commercial production facility and have not addressed that quality must begin at inception of the initial concept and that relies on it being implemented all the way back to the primary investigator in his university or company laboratory. Though the research laboratory operates at a much smaller scale and modality, still all the essential requirements and expectations of TQM and Good Manufacturing Practices (GMP) apply. Ensuring that initial research and development meets the expectations of safety, efficacy and potency is why TQM is probably even more important within academic institutions. The absence of guidelines being applied to the university and developmental laboratory environments makes this book an essential part of any research library. It is a comprehensive reference book for university students, a hands-on manual for laboratory technicians, and a practical guide for biopharmaceutical managers.
Autorenporträt
Dr. Goldenthal has three decades of experience in medical research. The author uses his vast knowledge of viral vaccine development and large molecule therapies to aid in the ongoing battle against cancer and since 2009, Dr. Goldenthal has worked on several long term consulting projects in Chengdu, Beijing, and Wuhan China and in Dongtan, South Korea. His considerable knowledge in the biotechnological field, but also his expertise in pharmaceutical Good Manufacturing Practice, Pharmaceutical Regulatory Affairs and Quality System Management has gained him the respect of his colleagues within the industry. In particular, his significant contribution to the team working in Chengdu in order to achieve WHO prequalification for CDIBP, part of the CNBG groups of companies, was a critical success factor and much was due to his performance, not only on the design and implementation of operational systems but also his ability to perform the biostatistics on demonstrating the bioequivalence of the vaccines between the old facilities and the new ones constructed. With his focus in metabolic diseases, cancer therapy, and aging processes, Dr. Goldenthal has long been considered the professional's professional and he is both widely acclaimed and widely sought after for his consulting services, working with agencies such as IKSA, PATH, SIDVIM and IVT worldwide. His knowledge on GMP and GLP issues within the industry is recognized by his peers to be of the highest level of knowledge of standards of implementation. Dr. Goldenthal has held director positions in Asia at Shenzhen Hornetcorn Biotechnology, Chiwi Bio Limited and the Faculty of Health Sciences at the University of Macau. In his previous work in the west, he is also a former director at PMC-Sanofi, and has held similar positions with Novotech Pharma, Massey University AHSC, and the Valley Animal Research Center. In recognition of all of his achievements, Dr. Goldenthal received the Anhui Province Accreditation for Immunotherapy by Foreign Experts in the city of Hefei in October 2013. He is a member of the College of Veterinarians of Ontario and the Veterinary Council of New Zealand, specializing in Laboratory Animal Medicine.