Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics (Paperback) (ISBN-13: 9780367394769)

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.

Author: Carmen Medina
ISBN-10: 0367394766
ISBN-13: 9780367394769
Publisher: CRC Press
Language: English
Published: 10/02/2019
Pages: 704
Format: Paperback
Weight: 2.00lbs
Size: 8.90h x 6.00w x 1.50d