From: Tuesday, August 11, 2009
To: Wednesday, August 12, 2009
Venue:
Doubletree Hotel, Philadelphia, PA USA
Agenda:
Develop viable products at a great speed without compromising safety, efficacy or quality. Hear an update from the ICH Quality Implementation Working Group. Learn about FDA’s new QbD program designed specifically for generic drugs. Analyze and apply FDA’s Draft Process Validation Guidance. Use a predictive distribution approach to the ICH Q8 definition of design space. Identify synergies between compliance and quality to extract business value inherent to both. Reduce product end-testing with Process Analytical Technologies (PAT). Identify IQ/OQ/PQ testing items for critical equipment. Understand how an open loop CAPA paradigm can improve quality and business performance. Tutorials and case explorations will be offered. For more information, call 1-800-817-8601 or visit www.cbinet.com/pharmtech or www.pharmtechevent.com.
