Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
CRC Press (Verlag)
978-0-367-39476-9 (ISBN)
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.
| Erscheinungsdatum | 01.10.2019 |
|---|---|
| Verlagsort | London |
| Sprache | englisch |
| Maße | 152 x 229 mm |
| Gewicht | 911 g |
| Themenwelt | Medizin / Pharmazie ► Pharmazie |
| Naturwissenschaften ► Biologie | |
| Technik ► Umwelttechnik / Biotechnologie | |
| ISBN-10 | 0-367-39476-6 / 0367394766 |
| ISBN-13 | 978-0-367-39476-9 / 9780367394769 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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