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.
For Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702324?channel=eventsbot