Feeling nervous about your FDA submission for your container/closure system?

Never fear, Piet Christiaens, PhD. of Toxikon Europe will be providing a 1 ½ hour online training seminar sponsored by the Parenteral Drug Association (PDA) on this very topic.

The Webinar, titled, "How to Design Extractable/Leachable Studies for Pre-Filled Syringe Applications," takes place Dec. 4 from 1-2:30 p.m. EST.

The presentation is tailored toward pharmaceutical research and development and primary packaging engineers, as well as quality assurance and regulatory affair managers.

The online training will provide extensive information on the regulatory guidelines for container/closure system testing, the mechanism of polymer migration and design of extractable and leachable studies. Dr. Christiaens will also provide insider knowledge on how to avoid common pitfalls in study set-up. His presentation will be illustrated specifically for a pre-filled syringe application.

Dr. Christiaens received his PhD. from the Analytical Chemistry Department of the University of Leuven (Belgium) and has served as Scientific Director at Toxikon Europe N.V. since 2001. He brings a wealth of knowledge and experience from his time working as a lab manager in two contract laboratories, as well as three years as an independent consultant for Shell Chemical Company in Houston, Texas.

Cost is $395 for the live or on-demand seminar for PDA members and $450 for non-members. For the combined live seminar and on-demand registration, cost is $640 for PDA members and $740 for non-members.
To register, visit www.pda.org  and click on the "Web seminars" icon, or contact Paula Pagano, PDA's Senior Manager for Programs & Web Seminars at (301) 656-5900 Ext. 149.