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Regulatory Sourcebook December 2019
REGULATORY UPDATE
4 Warning Letters Signal
Steps to Compliance
Rita Peters
QUALITY COMPLIANCE
6 Moving From
Compliance to Quality
Agnes Shanley
QUALITY RISK MANAGEMENT
12 Quality Risk Management
Plans Create Effective Quality Systems
Susan J. Schniepp
DESIGN OF EXPERIMENTS
14 Design of Experiments
Gains Ground in Biopharma Development
Agnes Shanley
PHARMACOPOEIA COMPLIANCE SERIES
17 Revision Process for
Global/National Pharmacopoeias
J. Mark Wiggins and Joseph A. Albanese
26 Surveillance Process for Industry:
Monitoring Pharmacopoeia Revisions
J. Mark Wiggins and Joseph A. Albanese
RESOURCES
38 Regulatory and Standard
Setting Organizations
41 Resources, Guidelines,
and Guidance Documents
43 Ad Index
Cover image: tamayura39 - stock.adobe.com; Cover design, Maria Reyes
