Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals 2017
- Start Date:
- Thursday, 27 April, 2017
- End Date:
- Friday, 28 April, 2017 6:00pm
- Pain Management, Endocrinology, Infectious Disease, Internal Medicine, Emergency Medicine, Pulmonary Medicine, Physical Medicine, Headache / Migraine
Overview: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 RegulationsClassify Your DeviceChoose the Correct Premarket Submission for your deviceCompile the Appropriate Information for your Premarket SubmissionAuthor and Prepare your Premarket SubmissionSubmit your Premarket Submission to the FDAInteract with FDA Staff during Review and ApprovalComplete 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 DevicesPremarket Notification (510k)Premarket Approval (PMA)Investigational Exemption Device (IDE)Points to Consider for preparing a Successful Premarket SubmissionTips and Suggestions on interacting with FDA OfficialsPost Market Requirements of Medical Devices Who will benefit:Regulatory Affairs Professionals (associates, specialists and managers)Marketing ProfessionalsResearch & Development - Product ManagersQuality Assurance and Quality EngineersProject Managers responsible for United StatesBuyers/Purchasing ProfessionalsStudents majoring in Regulatory Affairs Agenda:Lecture 1:An overview of U.S.
FDA Premarket RegulationsHistory and background of U.S FDA Laws and RegulationsHow to Classify Your DeviceChoose the Correct Premarket Submission for your deviceLecture 2:Premarket Notification 510(k)Applicable Laws, Regulations and Requirements for 510(k)Decide Type of 510(k)Compile the Appropriate Information for 510(k)Format and Content of your 510(k)Lecture 3:Premarket Notification 510(k) - continueSuggestions on What to Include or Exclude into your 510(k)Tips on authoring a reader's friendly and convincing 510(k)Critical Review of your prepared 510(k) for acceptabilityLecture 4:Premarket Notification 510(k) - continueDetermine risk and contingency plan for potential questions form the reviewerPoints to Consider - Submit your 510(k) to FDAInteract with FDA staff during review and clearance of your 510(k) Day 2 ScheduleLecture 1:Premarket Approval (PMA)Applicable Laws, Regulations and Requirements for PMADecide Type of PMACompile the Appropriate Information for PMAFormat and Content of your PMASuggestions on What to Include or Exclude into your PMATips on authoring a reader's friendly and convincing PMALecture 2:Premarket Approval (PMA) - continueCritical Review of your prepared PMA for acceptabilityDetermine risk and contingency plan for potential questions form the reviewerPoints to Consider - Submit your PMA to FDAInteract with FDA staff during review and clearance of your PMALecture 3:Investigational Device Exemption (IDE)Applicable Laws, Regulations and Requirements for IDEPurpose and Use of Pre-IDE to your advantageCompile the Appropriate Information for IDEFormat and Content of your IDESuggestions on What to Include or Exclude into your IDETips on authoring a reader's friendly and convincing IDELecture 4:Post Market Requirements for Medical DevicesQuality System (QS) Regulation/Medical Device Good Manufacturing PracticesMandatory Medical Device Reporting (MDR)Recalls, Corrections and RemovalsMedical Device TrackingPost Market Surveillance Studies (PSS) mandated under section 522 of the Federal Food, Drug and Cosmetic ActPost-Approval Studies (PAS) mandated as a condition of approval of a premarket submission - mostly premarket approval (PMA) applicationPoints to consider - Third Party Inspection by Accredited Persons Program limited to manufacturers who meet certain conditions Speaker:Subhash R Patel,Regulatory Affairs & Quality Compliance Consultant, MD Reg Consulting, LLC, 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.
Location: Raleigh, NC Date: April 27th & 28th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Courtyard Raleigh-Durham AirportAddress: 2001 Hospitality Ct, Morrisville, NC 27560, United States Price: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar Fee for One Delegate) Until March 20, Early Bird Price: $1,295.00 From March 21 to April 25, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email: email@example.com Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel?Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/Follow us on Twitter: https://twitter.com/GCPanel
Courtyard Raleigh-Durham Airport 2001 Hospitality Ct,
Conference organized by NetZealous DBA as GlobalCompliancePanel
- NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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