Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics -

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Carmen Medina (Herausgeber)

Buch | Hardcover
694 Seiten
2003
Crc Press Inc (Verlag)
978-0-8247-4078-8 (ISBN)
219,95 inkl. MwSt
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.

Carmen Medina

Regulatory submissions, Patricia Fritz and Anisa Dhalla; compliance requirements during the drug development process, Martin D. Hynes; validation - a new perspective, James Agalloco; validating analytical methods for pharmaceutical applications - a comprehensive approach, Paul A. Winslow and Richard F. Meyer; the stability testing programme, Maria Geigel; computer validation - a compliance focus, Timothy Horgan and Timothy Carey; compliance issues associated with cleaning in the pharmaceutical industry, William E. Hall; the batch record - a blueprint for quality and compliance, John Fugate; change management - a far reaching, comprehensive and integrated system, Susan Freeman; the vendor qualification programme, Eizabeth M. Troll and Karen L. Hughes; handling laboratory and manufacturing deviations, Robert B. Kirsch; the internal audit programme - a quality assessment, Graham Bunn; pre-approval inspections - the critical compliance path to success, Martin D. Hynes; international compliance issues and trends, Alan G. Minsk; strategic planning for compliance and regulatory defensiveness, Ron Johnson; unique and unprecedented compliance challenges in the biologics area, Anne Hoppe and Curtiss Scribner; the impact of total quality performance on compliance, Carmen Medina, Judith Beach, Valerie Palumbo and Douglas B. Poucher.

Erscheint lt. Verlag 9.12.2003
Verlagsort Bosa Roca
Sprache englisch
Maße 152 x 229 mm
Gewicht 1043 g
Themenwelt Medizin / Pharmazie Medizinische Fachgebiete Pharmakologie / Pharmakotherapie
Medizin / Pharmazie Pharmazie
Naturwissenschaften Biologie
Technik Umwelttechnik / Biotechnologie
ISBN-10 0-8247-4078-5 / 0824740785
ISBN-13 978-0-8247-4078-8 / 9780824740788
Zustand Neuware
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