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
Speaker
Subhash R Patel
Subhash Patel is an accomplished Regulatory Affairs Professional offering 30 plus year of experience in authoring, preparing and submitting more than 150 successful premarket submissions to U.S. FDA. He brings his expert knowledge and hands-on experience in developing a robust premarket submission that secures clearance or approval from U.S. FDA. He offers valuable tips and suggestions on "what works and what doesn't" form his own experience. He has presented numbers of technical papers at conferences and conducted plentiful training seminars in various countries.
He is a Fellow of world's renowned Regulatory Affairs Professional Society (RAPS) and holds professional recognition as a Regulatory Affairs Certified (RAC) form RAPS. He also holds professional certification as Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE) form American Society for Quality (ASQ). His educational background includes BS degree in Mechanical Engineering and BS degree in Chemistry. He founded MD Reg Consulting, LLC based in New Jersey, USA to serve medical device industry clients in all aspects of global regulatory affairs and specific to their needs.
Please fill in your name and email to receive the seminar agenda of this event.
Time: 8:30 AM to 5:00 PM
The agenda is available as PDF under downloads at the right side of the page.
Venue
Four Points By Sheraton San Diego Downtown
1617 1st Ave, 92101
San Diego, CA, USA
Who will benefit:
- Regulatory Affairs - VP, Director and Managers
- Regulatory Affairs - Associates and Specialists
- Compliance Officers
- Research & Development - Product Managers
- Quality Assurance and Quality Engineers
Venue
Four Points By Sheraton San Diego Downtown1617 1st Avenue
San Diego, California, 92101
