2011 Combination Products Workshop – P3- Design Verification and Validation

Web Code: ComboP3-11
Member/Nonmember Price: $75

Seminar Summary

Identification of appropriate design validation for combination products has been a hot topic recently for regulatory bodies and proper design of validation studies is critical to assure that your customers are satisfied and can appropriately use your combination products.  The purpose of this seminar is to provide insight into the development of design validation studies.  The presentations will address key questions regarding establishment of appropriate studies to assure that user requirements have been met.

Who Should Attend

Department Operations | Regulatory Affairs | Clinical Affairs | Manufacturing | Quality| Product and Process Development Engineering | Project Management

Job Function
Individuals, at all levels, working in strategic roles in quality, regulatory, clinical and manufacturing departments in drug, biologic or medical device companies engaged in the development and manufacture of combination products

Presenters Bio

Douglass Mead, Director, World Wide Regulatory Affairs, Medical Devices and Combination Products, Johnson & Johnson Pharmaceutical Research & Development, LLC  

Doug is Director, Global Regulatory Affairs, Medical Devices and Combination Products, for Johnson & Johnson, Pharmaceutical Research & Development LLC, and is responsible for establishing and implementing the worldwide regulatory strategy for the development of drug delivery systems for protein-based medicinal products and cell therapies. These include a variety of injector and infusion systems, microcatheters and cannulae, and nasal and inhalation devices. Before joining J&J’s Centocor in 2006, he held positions at a regulatory law firm, a pharmaceutical company specializing in drug delivery, various surgical instrument companies, and a medical device testing laboratory. He has an M.S. Degree in Biomedical Engineering from Drexel University and over 30 years of experience in the medical device, pharmaceutical, and combination products industries.

Peter Noymer, PhD, Vice President, Product R&D, Alexza Pharmaceuticals

Peter is Vice President, Product R&D at Alexza Pharmaceuticals, where he leads a department of scientists and engineers in applied research, CMC and product development efforts for Alexza’s proprietary inhalation products.  From 1999 to 2006, he held various management positions at Aradigm Corporation, developing drug delivery combination products for both inhalation and injection. Prior to Aradigm, Peter held an appointment as Visiting Assistant Professor at Carnegie Mellon University, as well as various engineering positions at GE.  He received M.S. and Ph.D. degrees in mechanical engineering from M.I.T., and a B.S. degree in mechanical & aerospace engineering from Princeton University.

Registration contact 

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org

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