Online Seminar 2019 - Live Webinar 90 minutes FDA's Recent Regulation on the Use of Social Media

Overview
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..
Session Highlights
1. Gain an understanding of FDA’s guidance on the use of social media
2. Understand FDA’s current thinking, as expressed in three draft guidance documents
3. Learn how to provide product benefit and risk information to stakeholders via social media
4. Learn how to deal with character space limitations that constrain the use of social media
5. Learn how to respond to misinformation about your company’s product(s) posted by independent third-parties
6. Understand pending regulatory changes under review by the US Congress
7. 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
Speaker Profile
Faculty 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. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
During her career, Carolyn collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.