Catalent To Present Webinar On Stabilities Studies In Pharmaceutical
on: October 30, 2009, 4:25 am
Author: Jennings and Co.
Pharma Solutions will host a free Webinar featuring Senior Manager,
Wei Pan, Ph.D. RAC and Kathy Waddle, Director, Stability QC Biology.
The one-hour Webinar will cover stability studies as a critical
part of the drug development process and the vital role they play
for drug product marketing approval. The Webinar, titled “Stability
Studies in Pharmaceutical Development,” will be held on
Friday, November 20, 2009 at 2 p.m. (EST). To register for the
Webinar please visit: https://www2.gotomeeting.com/register/280747146.
presentation will address the principles and practices of stability
studies in the drug development process. Pan and Waddle will discuss
the framework of the FDA cGMP guidelines as expressed in 21CFR211.
Additionally, the Webinar will provide a comprehensive review
of ICH and WHO stability guidelines by discussing the strategy
used in stability protocols designed to support global registration.
studies are conducted at all phases of the drug development cycle
for different purposes with the ultimate goal of having a stable
product on the market. During development, stability studies are
conducted to support the formulation development and safety and
efficacy claims of investigational new drugs. At registration,
they are conducted to ascertain the quality and shelf-life of
the drug product in their intended packaging configuration. After
approval, the stability studies are conducted to ensure the quality
of production and to support site or other changes to the product.
more information on Catalent’s broad range of drug and biologic
development services, go to www.catalent.com/development.
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 9,500
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 Details: Patricia A. McGee
(732) 537 6407