Edward Smith Packaging Science Resources, LLC

Dr. Smith is Principal Consultant at Packaging Science Resources which provides consulting and training in packaging for the pharmaceutical, biotechnology, and medical device industries. His focus is on parenteral packaging issues such as specifications, compatibility, package development and extractables and leachables.

Ed retired from Wyeth Pharmaceuticals in 2008, where he headed a team responsible for the development and qualification of cold chain packaging systems for transporting temperature-sensitive drug products. Prior to that, he was associated with Helvoet Pharma Inc. and West Pharmaceutical Services in various technical management positions. He holds a B.S. in Chemistry from Villanova University and received his M.S. & Ph.D. in Analytical Chemistry from Seton Hall University (So. Orange, NJ). He is a member of the PDA and ACS. Within PDA, he leads the Packaging Science Interest Group, and served on the Steering Committee of the Pharmaceutical Cold Chain Interest Group (PCCIG) where he co-authored PDA Technical Reports 39 on cold chain best practices and 43 on distribution. He is also a member of the PQRI Working Group on Parenteral & Ophthalmic Drug Products (Extractables/Leachables). He is a member of the faculty of the PDA Training and Research Institute. He is also a member of the ACS Consultants Network and is a Senior Advisor at Genesis Technical Advisors, a group formed to provide comprehensive packaging project management and training. He has published many articles and chapters on pharmaceutical packaging and is a frequent speaker at industry meetings and courses related to extractables/leachables and cold chain.