It's no secret that FDA is forever changing. In June, CDRH enforcement director Bill McFarland told FDLI that the agency would take new initiatives to place greater emphasis on quality operations and on compliance during quality system inspections. How can medical device manufacturers meet this evolving need through compliance activities? This webcast aims to help medical device regulatory personnel, the company's quality team, and product life cycle managers tackle the challenges facing compliance issues in an ever-changing compliance landscape. Attendees will gain insight on:
- Understanding the present FDA regulatory posture for compliance.
- Preparing for an FDA inspection.
- Reducing costs and risk in meeting FDA requirements.
- Implementing CAPAs.
- Ensuring the right controls are in place.
The experts will discuss what FDA's new compliance posture means for the medical device industry. Attendees will receive tips on how to respond to FDA 483s and how to prevent getting Warning Letters. They will also get practical advice on Agile technology, traceability for end-to-end systems, and eliminating wasted processes and procedures.