Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
Crc Press Inc (Verlag)
978-0-8247-4078-8 (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.
| 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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