November 1 - December 6 -- Introduction to FDA Regulations and Compliance: cGMP and cGLP X475.1 (2 semester units in Public Health) provides a thorough overview of current Good Manufacturing Practice (cGMP) and current Good Laboratory Practice (cGLP) regulations as enforced by the U.S. Food and Drug Administration (FDA) for the pharmaceutical, biologics, medical device, and diagnostics industries. Students are introduced to the current regulations and requirements and the rationale behind them.

The instructor discusses inspections, validations, and the International Harmonization process. Students also learn from a practical standpoint how to apply and comply with the regulations and why they are so important. This course benefits anyone working or seeking employment in FDA-regulated biomedical industries.

Prerequisite: Some knowledge of FDA-regulated industries is recommended.
DARWIN WILLIAMS, M.S., has an active consulting practice specializing in cGMP/cGLP compliance, data evaluation, and test method validation. He has more than 20 years of experience in quality assurance, quality control, and domestic and international regulatory compliance. He has held managerial positions in both biologics and medical device companies, and has conducted training programs in FDA compliance.

* 5 meetings
* Nov. 1 to Dec. 6: Sat., 9 am-4 pm
* San Francisco: Room 811, UC Berkeley Extension Downtown Center, 425 Market St., 8th Floor
* $985 (EDP 408302) to enroll
Textbook for this course:
From Alchemy to IPO
Author: Cynthia Robbins-Roth, Ph.D.
Publisher: Pereus
Publication Year: 2001
ISBN: 0073820482-X

To register go to www.unex.berkeley.edu