May 21-22, 2007 | Bethesda, Maryland

Download brochure (260 KB) This one-and-a-half day workshop will bring together industry and regulatory representatives to address the application of QbD concepts as applied to various aspects of biopharmaceutical manufacturing, including process development and design, process characterization, validation, regulatory filing and process monitoring. Topics of discussion will include: QbD definition and concepts QbD impact on process development and design Case studies of QbD in the biopharmaceutical world Impact of QbD implementation on different departments: process development, quality, manufacturing and regulatory  Featured FDA speakers include: Barry Cherney, PhD, Deputy Director, Division of Therapeutic Proteins, CDER Richard Friedman, Director, Division of Manufacturing and Product Quality, CDER Chris Joneckis, PhD, Senior Advisor for Chemistry, Manufacturing and Control (CMC) Issues, CBER Patrick Swann, PhD, Deputy Director, Division of Monoclonal Antibodies, CDER Janet Woodcock, MD, Deputy Commissioner and Chief Medical Officer

Who Should Attend

Departments Regulatory Affairs | QA/QC | Manufacturing Operations | Engineering Job Function Process Development | Consulting | Biopharmaceutical Manufacturing | Biopharmaceutical Quality Management

Contacts

Jason Brown Senior Programs and Meetings Coordinator Tel: +1 (301) 656-5900 ext. 131 E-mail: brown@pda.org For more information about obtaining a U.S. visa, visit http://www.unitedstatesvisas.gov.