Seminar March 16-17. 2011

ACI FDA Boot Camp

Event Detail
Cathy L. Burgess
March 16-17. 2011
New York, NY

Cathy Burgess presented, "cGMPs:Drugs and Biologics (current Good Manufacturing Practices)," during this conference sponsored by the American Conference Institute.  Cathy's session covered the following topics.

  • Examining cGMPs and the scope of their importance in pharmaceutical/biological product commericalization
  • Looking at how cGMPs factor into the scope of their importance in pharmaceutical/biological product commericalization
  • Exploring the scope of the FDA's cGMP Initiative and how the concept of "risk-based" cGMPs is defined
  • Defining the concept of validation
  • How are laboratory investigations in relation to cGMPs conducted?
  • Defining the term "quality systems"
  • How are cGMPs factoring into products litigation?
  • Evaluating the cost of enforcement actions: what happens to company stock when there is an announcement of an enforcement action?

March 16-17, 2011
Flatotel / New York, NY

 

 

Meet The Speakers
Media Contacts
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Senior Communications Manager
Phone: 212.210.1222
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