Bethesda, Md. (November 7, 2008): The Parenteral Drug Association (PDA) has confirmed that FDA’s J. David Doleski and Nicole Trudel will co-present during the Opening Plenary Session at the 2009 PDA Annual Meeting in Las Vegas, Nevada, April 20-24, 2009. Doleski and Trudel will co-present on Computer Systems Applications within a cGMP Environment. Their presentation will set the stage for conference sessions emphasizing innovative ideas and practical tools for applying modern technologies to the development, manufacture and testing of pharmaceutical products and processes.
Doleski has worked for the Food and Drug Administration (FDA) for 19 years. Currently, he serves as Team Leader in CBER’s Division of Manufacturing and Product Quality (DMPQ). For more than seven years, he has reviewed Chemistry, Manufacturing and Controls (CMC) sections of biologics license applications and supplements. To date, he has performed 15 pre-approval and pre-license inspections. Doleski has participated in various policy groups, including FDA's Part 11 Committee. He was awarded CBER's Mentoring Award in 2008. Doleski received his BS in Biology from Cornell University and a second BS in Computer Information Systems from the University of Maryland University College.
Trudel currently works for FDA as Reviewer in CBER’s Division of Manufacturing and Product Quality (DMPQ). Her duties include reviewing Chemistry, Manufacturing and Controls (CMC) information in biologics license applications and supplements; conducting pre-approval and pre-license inspections for biologics; and participating in various policy groups addressing CGMP, harmonization and inspection related issues for biologics. She is an active participant in the Global Harmonization Task Force (GHTF), and is the CBER representative to GHTF Study Group 3 for Quality Systems. Trudel also has industry experience in the bio-defense arena, and was previously the Chief, Test and Evaluation at the Joint Program Executive Office for Chemical and Biological Defense. She received her BS in Mechanical Engineering from the University of Maine.
These Opening Plenary Session presentations will set the stage for two-and-a-half days of conference sessions focused onThe Impact of the Microchip - Application of Modern Technologies in the Development, Manufacture and Testing of Bio/pharmaceutical Products. These sessions will examine the systems and tools that can help you and your company maximize efficiency and productivity, while consistently delivering safe, pure and reliable drugs to patients.
Immediately following the conference, the PDA Training and Research Institute (PDA TRI) is offering courses to complement conference sessions.
The 2009 PDA Annual Meeting will be held in Las Vegas, Nevada, April 20-24, 2009, at the Red Rock Casino, Resort and Spa.
For more information, visit www.pda.org/annual2009.