The U.S. FDA's New Global Engagement Initiative

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.

Areas Covered in the Seminar:

• The U.S. FDA's New Global Engagement Initiatives.
• Recent global industry trends, bad and good.
• Major foreseeable problem areas.
• How the FDA initiatives impact regulated industries.
• Immediate actions to take.
• Long-term correction / preventive action of FDA-defined problem areas.

Who Will Benefit:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering