Wednesday, June 26, 2013
Dr. Woodcock Confirmed to Speak: Understanding cGMPs - What Attorneys Need to Know
WASHINGTON, June 26, 2013 /PRNewswire-USNewswire/ -- Professionals working in the pharmaceutical and biologics industries, especially lawyers, need to understand the current framework for creating and following current Good Manufacturing Practices (cGMPs), and the steep legal and regulatory consequences for failing to meet those standards. This one-day, (FDLI), program is specifically tailored for lawyers, but appropriate for all drug and biologics stakeholders. The July 10 conference in Washington, DC will provide an overview of cGMPs (including revisions mandated by enactment of Section 711 of FDASIA), how evaluates company compliance with cGMPs (including an examination of recent guidelines published by the International Conference on Harmonization and the latest developments on quality by design), and practical advice for how to remain current and compliant. Don't miss this opportunity to learn directly from FDA and industry experts about the most current methods for compliance and quality management.
Confirmed government participants: Janet Woodcock, M.D., Director, , Office of Medical Products & Tobacco, FDA; Ilisa Bernstein, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, Office of Medical Products & Tobacco, FDA; Laura A. Rich, Chief, Regulations and Policy Staff, Office of the Center Director, Center for Biologics Evaluation and Research, Office of Medical Products & Tobacco, FDA; Douglas Stearn, Deputy Director, Policy and Analysis, Office of Compliance, Center for Drug Evaluation and Research, Office of Medical Products & Tobacco, FDA; Jeffrey Steger, Assistant Director, Consumer Protection Branch, Civil Division, U.S. Department of Justice.
The Food and Drug Law Institute