Topics that are new to PQLI will be introduced as the project expands to understand how the ICH Quality Vision can be implemented globally. Challenges that companies face introducing or adapting change management and knowledge management in a pharmaceutical quality system will be discussed from the viewpoint of both industry and regulators whether or not an 'enhanced,' quality by design approach is used. Regulators from FDA, EU and Japan will be invited to provide their findings reviewing applications and inspecting companies. Leading industry speakers will be asked to summarize their experiences. Opportunities will be given for participants to interact with regulators and industry colleagues. At the conclusion of this session, participants will be able to:
Richard L. Friedman is Associate Director, Office of Manufacturing and Product Quality, Center for Drug Evaluation and Research (CDER), Office of Compliance, FDA. In this position, he is responsible for oversight of CGMP and drug quality programs to assure scientific and risk-based decisions. This position includes review of major regulatory action recommendations regarding inspections and manufacturing site acceptability; promoting sound risk management of major defects (e.g., potential recalls); program prioritization; and analyzing emerging drug quality trends. Mr. Friedman is also the co-chair of FDA's Pharmaceutical Quality Systems Workgroup, the Standards Working Group, and the CDER/ORA Strategic Science and Compliance Committee.
Mr. Friedman joined FDA in 1990 and his positions have included New Jersey District Drug Specialist, CDER Senior Compliance Officer, Team Leader of Guidance & Policy, and Division Director. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems, and was awarded The George M. Sykes Award by the Parenteral Society for outstanding journal paper for the year 2005. He also recently received the 2011 Kenneth Chapman Achievement Award from the Institute of Validation Technology, and the 2012 Gordon Perseneus Award from PDA for scientific contributions in the area of drug quality. Mr. Friedman is an adjunct faculty member of Temple University School of Pharmacy in their QA/RA graduate program. Prior to joining FDA, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.