Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)

This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 days, the following essential topics will be covered:

• Total Product Life Cycle and Your Medical Device
• An Overview of U.S. FDA Medical Device Regulation
• Regulations for Design and Product Development
• Premarket Notification - 510(k) and Premarket Approval (PMA)
• Regulations for Production & Process Control
• Readiness for FDA Facility Inspection

Why should you attend:

The complex network of multilayer laws, regulations and regulatory requirements create confusion and misinterpretation that leads the device manufacturer into Non-compliance state. Non-compliance to applicable laws and regulations results into severe penalties or regulatory actions form U.S. FDA that could damage image and position of the company. To avoid such undesired circumstances, it is important to see a big picture of TPLC and all applicable U.S. FDA laws and regulation at each phase of their own product life cycle.

Areas Covered in the Session:

• An Overview of U.S. FDA Regulation for Medical Devices
• Quality System Regulation 21 CFR 820: Current GMP for Medical devices
• Premarket Notification - 510(k) and Premarket Approval (PMA)
• Post Market Reporting Requirements
• FDA Facility Inspection

Who will benefit:

• Regulatory Affairs - VP, Director and Managers
• Regulatory Affairs - Associates and Specialists