Do you understand the FDA Guidance "Recognition and Use of Consensus Standards"?

Instructor: Cheryl Wagoner
Product ID: 703584
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542


Read Frequently Asked Questions

This FDA compliance webinar will discuss in detail the guidance on recognition and use of consensus standards. It will focus on the topics such as voluntary conformance, declaration review and content of declaration of conformity.

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:

  1. Background of the guidance
  2. Procedures for the use of consensus standards
  3. General usage
  4. Voluntary conformance
  5. Declaration review
  6. Content of “Declaration of Conformity”
  7. How does this align with ISO?
  8. Limitations of consensus standards
  9. 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

Instructor Profile:

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.

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