U.S. FDA`s Strategic Priorities - 2016 and Beyond

Topics

• The FDA’s "Strategic Priorities" for the period until 2018
• Major "Drivers" and New U.S. FDA Initiatives
• Device, Pharmaceutical, Biological and Combination Products Issues
• Major foreseeable problem areas for 2016 and beyond
• Major and Pending 510(k) Changes
• CGMP Issues - Strengthened Compliance
• FDA`s Life Cycle Requirements
• The Global Supply Chain
• A company gap analysis vis-à-vis FDA priorities
• Navigating through "Better Science"
• Expanding "risk based" applications
• Correcting problem-prone areas

Who should Attend

Senior attendees involved or interested in:

• Engineering Staff
• Research & Development
• Quality Assurance
• Software Department
• Manufacturing
• Regulatory Affairs
• CGMP instructors
• Operations
• Mid-level and Senior Management
• Consultants
• Personnel involved in planning, execution and documentation
• Personnel involved in verification and/or validation