FDA's Recent Regulation on the Use of Social Media

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Listen By Carolyn Troiano industry reviewer for 21 CFR Part 11, the FDA’s (ER/ES) regulation. along with computer system validation and risk management/compliance at a number of Fortune 100 firms."

Medical devices subject to FDA regulation

Description

This Webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical in order to develop the appropriate strategy, policies and procedures to ensure compliance.

Why should you attend

As social media use explodes, companies in FDA-regulated industries will need to understand the current and pending regulations in order to meet compliance requirements. The attendee will be provided with the FDA’s current thinking and the rationale behind it. The attendee will also learn ways to meet compliance objectives in a cost-beneficial manner

Areas Covered

•         Gain an understanding of FDA’s guidance on the use of social media
•         Understand FDA’s current thinking, as expressed in three draft guidance documents
•         Learn how to provide product benefit and risk information to stakeholders via social media
•         Learn how to deal with character space limitations that constrain the use of social media
•         Learn how to respond to misinformation about your company’s product(s) posted by independent third-parties
•         Understand pending regulatory changes under review by the US Congress
•         Understand some of the key “pitfalls” to avoid when employing social media capability in an FDA-regulated                 environment

Who will Benefit

Professionals in the following industries may also benefit from the content:
•         Pharmaceutical
•         Medical Diagnostics
•         Biotechnology
•         Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
•         Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
•         Information technology managers and analysts
•         QC/QA managers and analysts
•         Clinical data managers and scientists
•         Compliance managers
•         Lab managers and staff
•         Automation analysts
•         Computer system validation specialists
•         GMP training specialists
•         Business stakeholders and individuals who are responsible for computer system validation planning,                          execution, reporting, compliance, and audit
•        Consultants working in the life sciences, tobacco and related industries who are involved in computer system             implementation, validation and compliance

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries.   She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs

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