Catalent to Present Webinar on Regulatory Documents Surrounding Extractables and Leachables Testing Requirements
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.
Contact:
Patricia A. McGee
(732) 537 6407
patricia.mcgee@catalent.com
Dan Dunlop, Jennings
Peggy Albertson, Jennings
(919) 929-0225
ddunlop@jenningsco.com
palbertson@jenningsco.com
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