Catalent to Present Webinar on Regulatory Documents Surrounding Extractables and Leachables Testing Requirements

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Released on: March 12, 2010, 12:10 am
Author: Jennings and Co.
Industry: Pharmaceuticals

Research Triangle Park, NC, March 12, 2010 – Catalent Pharma Solutions will host a free webinar featuring Principal Scientist, Alan D. Hendricker, Ph.D. The one-hour webinar provides an introduction to the regulatory documents surrounding leachables and extractables testing requirements for pharmaceutical products intended for US submission. The presentation, titled “Leachables and Extractables: Regulatory Context,” will be held on Thursday, March 18th from 2:00 p.m. to 3:00 p.m. EDT. To register for the webinar, please visit: https://www2.gotomeeting.com/register/290022131.

The presentation will be beneficial to all managers, directors, and vice presidents of small and large pharmaceutical companies that are working in product development of all dosage forms. The regulatory documents covered will include those for MDI, DPI, nasal spray, topical, oral and parenteral drug products. Additionally, the webinar will explore other applicable guidance and recommendation documents including: ICH guidance, Product Quality Research Institute (PQRI) recommendations, and EMEA and FDA guidance on genotoxic and carcinogenic impurities. The webinar will conclude with direction on modern approaches to applying this information in an analytical laboratory.

Catalent Pharma Solutions provides expert extractables and leachables services to the pharmaceutical industry with a focus on applying their industry leading scientific, regulatory and compliance expertise to all dosage forms and drug delivery platforms. Participants can expect to learn from Catalent’s expertise in these areas and take away an understanding of regulatory documents surrounding extractables and leachables testings, modern approaches and strategies to these testings, and guidance in analytical laboratory actions.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing, packaging and printing services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,100 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue. For more information, visit www.catalent.com.