PDA Names Robert L. Dana Sr. Vice President for Regulatory Affairs and PDA TRI 1 February, 2009

Bethesda, Md. - In January 2009, Robert L. Dana, a long time PDA member, assumed new responsibilities within PDA.  In his new role as Senior Vice President, Regulatory Affairs and Training and Research Institute, he will report to Bob Myers, President of PDA, and will also maintain a dotted line relationship to Rich Levy, PhD, Sr. VP, Scientific and Regulatory Affairs, PDA and will continue to serve as PDA’s regulatory authority.

In his previous position as Vice President, Quality and Regulatory Affairs, Bob worked with key regulators in the U.S. FDA, EMEA and Japan; as well as serving as a staff liaison to PDA’s Regulatory Affairs and Quality Committee.  He will continue to be responsible for these activities in his new position.

He has also been an instructor for TRI courses and training functions and has worked closely with TRI staff to help identify several course offerings in the current curriculum.

In addition to his experience on the PDA staff, Dana has over 35 years experience in product development, quality, compliance and regulatory affairs, both in private industry and as an independent consultant.  He is a former member of the PDA Board of Directors.

Myers said that he expects TRI to continue to be a flagship operation, and build on its unique training capabilities at selected sites around the U.S., as well as at the unique first class Bethesda facility that enhances PDA’s hands-on laboratory training. Myers predicts that TRI will have record attendance in its Aseptic Processing Training Program in 2009, noting that the first three sessions are already sold out.

According to Myers, TRI is also in the process of conducting training for reviewers in FDA’s division of Manufacturing & Product Quality within CDER.