Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Herausgeber: Medina, Carmen

• Broschiertes Buch

Produktbeschreibung

A guidebook to FDA compliance, this text lists the necessary steps for meeting compliance requirements during the drug development process. Presenting comprehensive approaches for validating analytical methods for pharmaceutical applications, it covers important compliance and quality systems used in the FDA-regulated industries related to medical devices, pharmaceuticals, and biologics. The book includes topics such as validating analytical methods for pharmaceutical applications, stability testing, computer validation, vendor qualification, internal audit programs, and strategic planning for compliance and regulatory defensiveness.

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 704
• Erscheinungstermin: 2. Oktober 2019
• Englisch
• Abmessung: 226mm x 152mm x 38mm
• Gewicht: 907g
• ISBN-13: 9780367394769
• ISBN-10: 0367394766
• Artikelnr.: 58055800

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.