Bethesda, Md. - The Parenteral Drug Association Training and Research Institute (PDA TRI) and the PDA Israel Chapter are teaming up this July to bring the Institute’s world-class training for the pharmaceutical/biopharmaceutical industry to Israel, with two courses covering regulatory hot topics.
Top PDA TRI faculty will present training courses on Quality Risk Management and Process Validation and Product Lifecycle, both cover topics central to currently evolving regulatory guidelines worldwide.
The Quality Risk Management course, to be held July 6-7, will use a combination of lectures and workshops to provide participants with practical information as to how to implement Quality Risk Management in a cost-effective and beneficial manner.
The Process Validation and Product Lifecycle course, to be held July 8-9, will review the draft FDA guidance in-depth, use case studies to demonstrate approaches to implementation and discuss how existing (legacy) facility, equipment and products, where qualification / validation was performed five, 10 and in many cases 20 years ago, can be brought into compliance with the expectations for ongoing verification.
The Director for both courses, Hal Baseman, Chief Operating Officer and a Principal at ValSource LLC., has over 30 years of experience in pharmaceutical operations, validation, and regulatory compliance and is a frequent instructor for PDA TRI. Hal recently received PDA’s 2009 James Agalloco Award for Excellence in Education. He will be supported by additional course faculty, Raphy Bar, Robert Dana, and Karen Ginsbury. Both courses will be held in English at Lev HaKongressim, Weizmann Science Park, Rehovot, in Israel.
To learn more about these courses please visit http://pdaisrael.co.il/tri.html. If you are interested in having PDA TRI bring instructors and courses to you please contact Robert Dana or visit our website for more information (www.pdatraining.org).