The New FDA-Product Approval, Inspection, and Enforcement

Edwin L Bills
Instructor Edwin L Bills
Product Id 600059
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

The New FDA-Product Approval, Inspection, and Enforcement

Overview:
The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration.

The new commissioner recently announced a new policy for Warning Letters and FDA-483 responses, putting manufacturers under very tight response timelines. The CDRH director recently retired under a cloud of complaints from center scientists about device approvals being too friendly to manufacturers. More inspectors are taking to the field to attack the backlog of inspections, and FDA is once again pushing third party inspections as another strategy to reduce backlog. The commissioner is speaking about returning to the mission of the agency, protecting the public health, All of these changes bring uncertainty to device approvals and the ability of manufacturers to keep products on the market.

Areas Covered in the seminar:
  • The "new" FDA organization and mission
  • Enforcement changes- increased inspection
  • Enforcement Changes-new expectations
  • Manufacturers responsibilities for FDA-483s
  • Manufacturers responsibilities in Warning Letter situations
  • Pre-market changes-Human Factors
  • New Risk Management Guidance

Who Will Benefit:
  • Regulatory Managers
  • Quality Managers
  • Product Managers
  • Project Managers
Speaker Profile
During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.

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