Is Device Registration and Listing Stressing You Out?
Instructor:
Cheryl Wagoner
Product ID: 703571
Training Level: Intermediate
- Duration: 60 Min
Why Should You Attend:
There is no current guidance available on device registration and listing. Though there is much information on the FDA website about who must register and list, how to register and list, it can all still be a bit confusing to coordinate the payment process with accomplishing the actual registration or device listing.
During this 60-minute webinar, the speaker will provide key information and practical knowledge that will help you to sort through the confusion and have your medical device facility or establishment registered and product listed.
Areas Covered in the Webinar:
- Background of the device registration and listing
- How does registration and listing relate to MDUFMA?
- What is FURLS?
- Who must register and list?
- When are you required to register and list?
- How do you register and list?
- How do you pay your annual fee for registration?v
- Do you need a US Agent? If so, what are the responsibilities of the agent?
Who Will Benefit:
This webinar will provide valuable assistance to following personnel in the medical device industry:
- Regulatory affairs
- Project managers
- Staff involved with regulatory filings
- Product Development managers
- Documentation
- Senior Management
- Finance
Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.
Cheryl is a member of Regulatory Affairs Professionals (RAPS), and the Association for the Advancement of Medical Instrumentation (AAMI). She completed the RAPS Executive Development Program at the Kellogg School of Management.
More Training By Experts
- Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance
- Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)
- Creating a Global Regulatory Plan
- How to file a 510(k) when your device is (or contains) software
- Is your Essential Requirements Checklist (ERC) up to snuff?
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
