Carmen Medina

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Herausgeber: Medina, Carmen

• Gebundenes Buch

Produktbeschreibung

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.

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 696
• Erscheinungstermin: 9. Dezember 2003
• Englisch
• Abmessung: 235mm x 157mm x 42mm
• Gewicht: 1142g
• ISBN-13: 9780824740788
• ISBN-10: 0824740785
• Artikelnr.: 21958615

Autorenporträt

Carmen Medina

Inhaltsangabe

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.