Good Documentation Practices (GDP) is essential in regulated manufacturing and laboratory environments. Personnel in these fields need to closely adhere to GDP in order to ensure an auditable account of work performed. GDP is required for all documentation included in a fully developed quality system. This live webinar will cover USP–NF General Chapter <1029> and an overview of GDP, including guidance for writing and correcting documentation as well as the various documentation required by U.S. FDA 21 CFR Part 11 (electronic records and electronic signatures) as applicable to all stages of product development.
Couse Duration (hh:mm:ss): 01:50:00
Kim Huynh-Ba, Ph.D
Executive Director, Pharmalytik
USP Council of Experts
Chair, USP Good Documentation Practices Expert Panel (2010-15)