Description
<strong>Course Schedule - 6-8 April 2009</strong><br/><br/>This course will provide a basic understanding of the FDA
Scaleup and Post Approval Changes Guidelines & the recent
guidelines 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 scale-up/scale-down, 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:<br><br>
<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.
11/17/2008
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,C8-233,0904-205.pdf
Address
Amsterdam, The Netherlands Europe