The U.S. FDA's New Global Engagement Initiative - Webinar By ComplianceOnline

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:-

• 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
• All personnel involved in a U.S. FDA-regulated environment  especially those involved in new product development, line extensions, and incremental product improvements, having to evaluate those changes to existing FDA-cleared 510(K)'s, and then document their decisions in harmony with regulations.