Wednesday, January 16, 2013
7:00 a.m. - 9:00 a.m.
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Tuesday, January 15, 2013 12:00 p.m.
Where Marriott La Jolla
4240 La Jolla Village Dr
La Jolla, California 92037
FDA Perspective: Analyze the Regulatory Landscape for Outsourcing
Marlene Swider, Quality Manager, FDA
There are many benefits of outsourcing, but along with those comes increased responsibility for defining roles and maintaining regulatory compliance. Understanding the FDA guidance in this area can help companies navigate these arrangements and better determine the appropriate actions for both sponsor and license holder. In this session, explore the impact of FDA guidance on outsourcing processes.
Please join us for this informative presentation which will be followed by moderated Q&A by:
Timothy Scott, President Pharmatek Laboratories, Inc. &
David Lyon, Sr. Vice President, Bend Research
Planner Ashleigh Berry