The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: June 19, 2012 from 10am to 11:30am
Location: Online Event
Street: 2600 E. Bayshore Road
City/Town: Palo Alto
Website or Map: http://www.complianceonline.c…
Phone: 16506203915
Event Type: medical, training
Organized By: Referral
Latest Activity: May 22, 2012
This 90-minute webinar will discuss the new FDA "Global Engagement" Initiative for new areas for heightened CGMP compliance from U. S. FDA-regulated companies and their global partners. It will cover areas for increased awareness, focus, and remediation, and the approaches that are now mandated.
Why Should You Attend:
The last two years have seen major initiatives at the FDA; as well as prominent drug and device failures over cGMP issues, resulting in recalls, lawsuits, class action lawsuits, and even possible criminal prosecution. The FDA sees globalization as a growing reality, and potential contributor of major regulatory issues: the supply chain, counterfeiting, clinical trials, other global outsourcing actions; by global / multinational corporations. A new paradigm for FDA guidance and strengthened enforcement is called for.
Areas Covered in the Seminar:
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