Biography of Edward J. Smith, Ph.D.

July 2008

Ed Smith is Principal Consultant at Packaging Science Resources which provides consulting and training in packaging for the pharmaceutical, biotechnology, and medical device industries.  Services include:

• Guidance on Cold Chain Transport and Storage for Vaccines and Temperature-Sensitive Pharmaceuticals
• Development of Extractables and Leachables Management Strategies
• Total Package Development for Parenteral Drug Products
• Specification and Test Protocol Development for Packaging Materials and Components
• DMF Preparation and Filing
• Guidance on Compliance with  FDA, USP, Ph. Eur., JP, and ISO
• Training on Packaging Principles, Practices, and Regulations

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, ACS, and loPP.  Within PDA, he leads the Packaging Science Interest Group, and is on the Steering Committee of the Pharmaceutical Cold Chain Interest Group (PCCIG) where he co-authored PDA Technical Report 39 on cold chain best practices.  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.  As a member of ISO/TC 76 he represents the U.S.A. at ISO forums on pharmaceutical packaging.  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.

Contact Information…

Edward J. Smith, Ph.D.
Packaging Science Resources
Pharmaceutical Packaging Consulting and Training
237 Chapel Lane
King of Prussia, PA 19406
USA

Office: 610-265-9029
Cell: 484-433-1449
Email: esmithpkg@msn.com
Web: www.gentechadvisors.com