Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally.
Examination of two recently published reports by the FDA`s CDRH (devices) have identified major areas of concerns:
1) 510(k) Working Group`s Preliminary Report and Recommendations, and
2) Task Force on the Utilization of Science in Regulatory Decision Making. Both Preliminary Reports and Recommendations were published August 2010, and stakeholders / industry is invited to comment. They recommend action on the part of both the FDA and industry. Clarification of terms and expectations. A review of these reports and 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. A brief overview of their changing focus re: medical devices and ICH Q10 re: pharmaceuticals; multi-site company operations, and the supply chain; trends evident in 483 observations and Warning Letters, will also be reviewed. Companies need to evaluate their own systems and future submission in light of this new emphasis. Anticipation and addressing of weak spots proactively will further prove a company is "in control", assist in timely review of submissions to the Agency, and in any remediation efforts.
Why Should You Attend: There is been a major shift in the emphasis of the U.S. FDA cGMP compliance audits, clinical trial expectations, product submissions and company response requirements. In short, all regulatory areas are under evaluation. There is "no business as usual". This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Recent negative publicity on pharmaceuticals, devices, as well as events in unrelated industries have put pressure on the Agency to "get tough on compliance / enforcement". The 510(k) process is under evaluation. The public wants change. The FDA is responding. This webinar will examine CDRH`s two just published internal review of key processes and recommended changes that will impact devices. It also shows the Agency`s view on its own and industry`s weak spots and provides insight into its take on overall regulatory issues.
Areas Covered In the Session: - 510(k) Predicates and substantial equivalence
- A New De Novo Alternative
- Split Predicates; Other Possible 510(k) Changes
- Better Science / New Science Re: Regulated Products
- More Complete Risk / Benefit Information
- Life Cycle Considerations
- Other Current Regulatory Trends
Who will benefit: - Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants
