Fri 12 Mar 2010
Catalent to Present Webinar on Regulatory Documents Surrounding Extractables and Leachables Testing Requirements
Posted by EPR Network under Biotech, Business, Chemicals, Featured, Healthcare, Internet & Online, Pharmaceuticals, Science
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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.
