This webinar will examine the FDA’s “Strategic Priorities” and related initiatives, with emphasis on 2019-2020. Such a review will focus on the broad range of issues a company’s senior management and QA/RA need to consider in their annual Management Review of their existing quality management system.
This reveiw takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what the FDA and industry need to do internally. An additional review of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of applicable FDA “Strategic Priorities” and related initiatives and areas for required review or related industry problem areas.
The result will be a basis for such a management review and a listing of likely milestones and tasks. Anticipation and addressing of weak spots proactively will further prove a company is “in control”, prepare proactively for and FDA inspection, and assist in timely review of submissions to the Agency, and in any remediation efforts.
- Mandated Areas for Annual Reviews
- The FDA’s “Strategic Priorities” for 2019 and Beyond
- Tougher Regulatory Science — What “Better Science” Really Means
- Device, Pharmaceutical and Biological Issues
- General cGMP Issues — Strengthened Compliance
- 510(k) Issues
- FDA’s Life Cycle View Requirements
- Safety / Integrity of Global Supply Chain
- Heightened Supplier Issues
- FDA Clearance / Approval Only the Beginning — Product “Lifecycles”
- Quality Assurance Departments
- Regulatory Affairs Departments
- Research and Development Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments