Date :
Place : United States, San diego
Website :http://bit.ly/1R38y3d-FDA-Laws-and-Regulations
Contact Person:John Robinson
Description:
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.Deadline for abstracts/proposals : 27th August 2016
Organized By :San Diego Seminar on Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)
Keynote Speakers : 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 numb
Conference Highlights :Overview: 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
Venue :Four Points by Sheraton San Diego Downtown, 1st Avenue, San Diego, CA, United States
Check the event website for more details.