Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals
This event qualifies for 12 RAPS
This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered:
- History and background of U.S FDA Laws and Regulations
- Classify Your Device
- Choose the Correct Premarket Submission for your device
- Compile the Appropriate Information for your Premarket Submission
- Author and Prepare your Premarket Submission
- Submit your Premarket Submission to the FDA
- Interact with FDA Staff during Review and Approval
- Complete the Establishment Registration and Device Listing
Why should you attend?
The U.S. FDA regulatory 510(k) clearance and Premarket Approval (PMA) process is considered a most stringent and complex. Only a good knowledge of U.S. FDA laws, regulations, and requirements is not sufficient to win a clearance/approval. You are required a proper training on how to set and state regulatory arguments for your device in a most convincing manner to the U.S. FDA reviewer.
This 2 days training seminar will walk you through building process of a reader’s friendly but resounding premarket submission and also give you tips and suggestions on how to work effectively with the U.S. FDA officials during review and approval process of your submission.
Areas Covered in the Session:
- Food, Drug and Cosmetic Act (FD&C Act)
- Title 21 Code of Federal Regulations (CFR) for Medical Devices
- Premarket Notification (510k)
- Premarket Approval (PMA)
- Investigational Exemption Device (IDE)
- Points to Consider for preparing a Successful Premarket Submission
- Tips and Suggestions on interacting with FDA Officials
- Post Market Requirements of Medical Devices
Who Will Benefit:
- Marketing Professionals
- Research & Development - Product Managers
- Quality Assurance and Quality Engineers
- Project Managers responsible for United States
- Buyers/Purchasing Professionals
- Students majoring in Regulatory Affairs
Speaker and Presenter Information
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.
Expected Number of Attendees
50Relevant Government Agencies
Dept of Education, FDA
This event has no exhibitor/sponsor opportunities
When
Thu-Fri, May 5-6, 2016, 8:30am - 5:30pm
Where
Courtyard Boston Logan Airport
225 William F. McClellan Highway
Boston, MA 02128
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Website
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Organizer
GlobalCompliancePanel
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