Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions

By following the principles outlined in this webinar, you will be able to minimize the risk of your submission being rejected and will increase the potential for a speedy review and approval by the FDA. You will learn what the FDA expects for a 510K submission.

Angela Bazigos
Instructor:
Angela Bazigos
Date:
Wednesday, October 30, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502747

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Overview:

The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.

Why should you Attend: In this webinar, you will learn what the FDA expects for a 510K submission. By following the principles outlined in this webinar, you will minimize the risk of your submission being rejected and you will increase the potential for a speedy review and approval by the agency.

Areas Covered in the Session:

  • FDA's Guidance on Refuse to Accept
  • Pre-Submission Interaction
  • 510(K) Refuse to Accept Policies and Procedures - High Level
    • The 510(k) Checklist
    • FDA Review Clock
    • Notification of Acceptance Review Result
  • Refuse to Accept Principles - Details
  • Refuse to Accept Checklist - Details
  • Acceptance Review Checklist - Details
  • Traditional vs Non-Traditional 510(K)s

Who Will Benefit:
  • Regulatory Personnel
  • Clinical Trial Physician / Doctor
  • Manager to Senior Director / VP of
  • Regulatory Affairs
  • Quality Assurance
  • Clinical Research
  • Data Management
  • Data Monitoring
  • Institutional Review Board
  • IT


Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.




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