Description
<strong>Course Schedule - June 8-10, 2009</strong><br/><br/>This course will provide a basic understanding of the FDA Scaleup
and Post Approval Changes Guidelines & the recent guideline
on changes to approved NDA or ANDA. This also addresses the
impact of withdrawal of the FDA BACPAC I guideline on changes
in API synthesis. The issues affecting batch size scaleup/scaledown,
various post approval formulation component or
composition changes, site of manufacturing changes,
manufacturing process changes, and/or equipment changes
will be addressed along with the issues affecting analytical
methodology, packaging and labeling changes.
The course will focus on:<ol><li>
The criteria that determines the level or degree of change.</li>
<li>The type of study data or information that must be generated
to support changes at each level.</li>
<li>The FDA recommended chemistry manufacturing & control
tests to support each level or degree of change.</li>
<li>The type of in-vivo or in-vitro testing required to support the
various levels of degrees of change.</li></ol>
Case examples will be employed to allow the students to
determine the type of data that are required to support the level
of changes proposed.
01/13/2009
To
01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Pharmaceutical
Course Category
Brochure Name
http://www.cfpa.com/PDF/2009/1948,C8-218,0906-201.pdf
Address
New Brunswick, NJ USA