About the Workshop Leaders

Arthur Falk, Ph.D., MBA, joined Elan in 2001 where he held the position of Executive Vice President, Corporate Compliance until his retirement in 2005. Dr. Falk has 30 years experience in analytical research, quality and compliance within the pharmaceutical industry. He received his BS in Chemistry from Rutgers University in 1966, his PhD in Medicinal Chemistry from the University of Illinois School of Pharmacy in 1972, and his MBA from Rutgers in 1990. Prior to joining Elan, he was the Vice President, Corporate Quality, Safety and Environmental Affairs and Managing Compliance Officer for the worldwide operations of the Warner-Lambert Company. In addition, Dr. Falk is the Chair for the International Pharmaceutical Excipients Council of the Americas and has been a member of the WHO Panel on Pharmaceutical Starting Materials.

Irwin Silverstein, Ph.D., is Chief Operating Officer of IPEA. Previously he was corporate director of quality assurance for International Specialty Products with responsibility for excipient, API, and medical device products. He has worked over 15 years with IPEC-Americas developing excipient GMP guidance documents. Dr. Silverstein holds both an American Society for Quality (ASQ) Certified Quality Auditor (CQA) and ISO 9000 Certified Lead Auditor (CLA) status. In addition, Dr. Silverstein is president of his own firm, IBS Consulting in Quality, LLC, which specializes in quality assurance and regulatory compliance for pharmaceutical excipient ingredients.

Dr. Silverstein has authored numerous articles in industry journals on excipient GMP compliance and auditing. Most recently, his articles have appeared in American Pharmaceutical Review (June '05 and Tablets & Capsules (July '05). Also of note is an article on Quality for the Kirk-Othmer Encyclopedia of Chemical Technology and a chapter on excipients in Validation of Active Pharmaceutical Ingredients