FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities
  • CODE : CARO-0070
  • Duration : 90 Minutes
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Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.


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.

Areas Covered

  • Pros and cons of using social media venues
  • Compliant use of Social Media in an FDA-regulated Environment
  • FDA draft guidance documents
  • Balancing benefit and risk information on social media
  • Managing character space limitations on social media
  • Managing misinformation posted by independent third-parties
  • Pending regulatory action by the US Congress
  • Q&A

Course Level - Intermediate

Who Should Attend

  • Information Technology Analysts
  • Business and IT Stakeholders responsible for computer systems used to access social media sites
  • Regulatory Affairs Personnel
  • Legal Specialists
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Compliance Managers
  • Marketing Managers and Staff
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Consultants working in the life sciences industry who are involved in FDA compliance
  • Auditors engaged in the internal inspection of labeling records and practices, as well as social media

Why Should You Attend

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, tobacco and tobacco-related (e-liquid, cigars). Functions that are applicable include marketing, regulatory affairs, compliance, sales, manufacturing, Quality Control, clinical study management, labeling, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the processes related to using social media to post product-related information.

Topic Background

There are three guidance documents issued in 2014 by FDA to guide industry in the use of social media. We will cover all three guidances and provide insight as to how to interpret and implement them. These guidance documents will help you navigate the use of social media to assure compliance.

The guidance documents relate to content, format and liability. It is important to know under what circumstances a company is responsible for social media posts about its branded products. We will also cover the role of “influencers” and how FDA is studying how these impact consumers.

We will also take a look at social media regulations from various areas of the world, where countries have implemented guidelines and requirements similar to those by FDA in the US. Finally, we’ll discuss the role of the Federal Trade Commission (FTC), as it continues working with FDA to fine-tune regulations.

  • $200.00



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