2011 Combination Products Workshop – P2- Design Input

Web Code: ComboP2-11
Member/Nonmember Price: $75

Seminar Summary

During this seminar, participants will hear from leading industry experts on establishing design inputs, user requirements and design requirements as starting points to the development process.

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

Donald DePalma, Principal Engineer, Design Control Systems, Cordis Corporation, a Johnson & Johnson Company

Don DePalma is an R&D Principal Engineer in New Product Development at Cordis Corporation. He joined Cordis in 1999 at the Miami Lakes, FL facility working for the Endovascular Franchise. There he worked on device development in the areas of Endovascular Aortic Aneurysm Repair and Carotid Stenting with Distal Protection. During the early 2000’s, Don was a key member of the team responsible for revising Cordis’ Design Controls system to incorporate requirements for developing pharmaceutical combination products. This system was reviewed and approved by the FDA, and the resulting process has become a benchmark for pharmaceutical combination product development within Johnson and Johnson.

In 2007, Don relocated with Cordis R&D to the Warren, NJ facility where he accepted the role of Design Controls System owner. In his current position, he is responsible for Cordis’ Design Controls System which involves system improvement, remediation, training, product development team support, and regulatory audit participation. He is also recognized at Cordis as a subject matter expert in the areas of Design Controls, New Product Development, Change Management, and Risk Management.

Lee Leichter, President, P/L Biomedical

Lee Leichter has over 35 years experience in the health care industry. He has been providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 15 years. Projects have encompassed a multitude of business, technical, regulatory and quality issues, mostly relating to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies and start-ups successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems.

He serves as an independent expert on the ISO technical committees for Injection and respiratory products, infusion pumps, needles and catheters, and AAMI Injection and Infusion Devices committees, helping establish the international standards for safety and performance of these products. He has also directly proposed and responded to FDA positions and proposals covering combination products, most recently as a consultant to the Combination Products Coalition.

He holds a Bachelors degree from the State University of New York at Stony Brook and an MBA with Honors from Florida Gulf Coast University. He is certified in USA and EU Regulatory Affairs.

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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