Good Documentation Practices (GDPs) in a cGMP Environment

Numerous types of documents are used in regulated industries, serving functions that include communicating instructions and information, and recording information. Participants in this course will learn the history of GDPs, strategies for implementing compliance, as well as standards and practices for accurately completing cGMP paper records. Requirements of 21 CFR 11, Electronic Records; Electronic Signatures, will also be addressed.

Fall 2017 Instructor: Amanda Barrett, Ph.D. 

Instructor Biography: Amanda Barrett earned a BS in Psychology and a PhD in Biomedical Sciences. She is currently completing a Masters of Business Administration at the University of Florida. Amanda has a distinct portfolio of experience in teaching, professional communication, cGMP quality systems, regulatory compliance, quality control, and technical writing for start-up and international biotech companies. She has extensive scientific expertise in project management, team leadership, and effective scientific communication. She has coordinated and conducted academic and private sector research, including upstream and downstream processing, fermentation, and cell culture. She served as Environmental, Health, and Safety Coordinator and delivered company-wide training on cGMP requirements and compliance with EH&S regulations.