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 by the Speaker ,Q/A and 90 Min Live Webinar

"Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries"

Ways to meet compliance objectives in a cost-beneficial manner

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•        Understand FDA’s current thinking, as expressed in three draft guidance documents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, Biotechnology,Pharmaceutical 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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