Do you understand the FDA Guidance "Recognition and Use of Consensus Standards"?
Instructor:
Cheryl Wagoner
Product ID: 703584
- Duration: 60 Min
Why Should You Attend:
In 2007, FDA published an update to the guidance entitled “Recognition and Use of Consensus Standards”. The version it replaced was issued in June, 2001. As with any guidance, for those in the industry, it is important to delve deeper and understand the nuances surrounding it.
Though guidance documents are not binding, they reflect the current thinking of the FDA. Even as a guidance is being drafted, this rule still holds true prior to its release. Therefore, the need to stay updated on guidance documents that may impact your business is now more than ever.
This webinar will offer a clear overview of the points covered under FDA’s recognition and use of consensus standards and elaborates every aspect within. It will also cover parallel topics such as declaration of conformity, aligning the same with ISO, limitations of consensus standards and more.
Areas Covered in the Webinar:
- Background of the guidance
- Procedures for the use of consensus standards
- General usage
- Voluntary conformance
- Declaration review
- Content of “Declaration of Conformity”
- How does this align with ISO?
- Limitations of consensus standards
- Recognition of consensus standards
Who Will Benefit:
This webinar will benefit the following personnel in the medical device industry:
- Regulatory managers
- Project managers
- Staff involved with regulatory filings
- Product development managers
Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She is currently 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).
