Exploring the FDA's Refuse to Accept Policy
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Instructor Profile:
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation's following action by the FDA.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description: The Office of Device Evaluation (ODE) receives approximately 6500 Premarket Notification (5100) submissions every year. Many of these submissions are incomplete or grossly inadequate, as they fail to contain the components necessary to allow substantive review of the submission and inappropriately consume Center resources. As a means to employ more effectively the Center's resources, the FDA has implemented procedures to ensure that 5 10Ks meet a minimum threshold of acceptability; otherwise the Center will refuse to accept the submissions for substantive review.
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Why Should you Attend: 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. 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. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives of the Presentation: The objectives of this webinar are to talk in detail about:
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FDA's Guidance on Refuse to Accept
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Pre-Submission Interaction
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510(K) Refuse to Accept Policies and Procedures – High Level – The 510(k) Checklist – FDA Review Clock – Notification of Acceptance Review Result
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Refuse to Accept Principles - Details
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Refuse to Accept Checklist - Details
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Acceptance Review Checklist – Details
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Traditional vs Non-Traditional 510(K)s
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Who can Benefit: •
Regulatory Personnel
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Clinical Trial Physician / Doctor
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Manager to Senior Director / VP
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Institutional Review Board
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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Recorded Session - How it works •
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Please click on the link to access the session
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Presentation handouts in pdf formate will be mailed to you
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