FDA Medical Device Regulation for the Beginner 2012 is a webinar that covers topics such as:
- Statutory and Regulatory Authority
- Organizational Structure
- Class I Medical Devices, 510(k) Premarket Notification and Premarket Approval
- Medical Device Classification System
- The Components of a 510(k) Premarket Notification
- The Process for Bringing a Medical Device to Market in the U.S
- User Fees
- A Manufacturer`s Responsibilities
- An Introduction to the Quality System Regulation (21 CFR Part 820)
- Labeling and Promotion
- Inspections
- The Import / Export of Medical Devices
- FDA Enforcement Activities
FDA Medical Device Regulation for the Beginner 2012 brings together:
- Managers
- Regulatory Affairs Professionals
- Scientists
- Consultants
- State Policy Officials
- Research Analysts
- Investment Analysts and Venture Capitalists
- Insurers focusing on Representations & Warranties Insurance
- Financial analysts and investors watching the life sciences industries
- Medical Device and Biotech Companies, Start-ups, Foreign Manufacturers, Importers, Labelers, Pharmacists, Convenience Kit Manufacturers