This seminar 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.
This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.
Areas Covered in the Session :
- 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- FDA draft guidance documents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
Who Should Attend:
- Information Technology Managers and Analysts
- Medical Affairs Managers and Analysts
- Clinical Data Managers and Analysts
- Marketing Managers and Analysts
- Compliance Managers and Analysts
- Regulatory Affairs Managers and Analysts
- GMP Training Specialists
- Business Stakeholders responsible for product presentation and promotional content
- Consultants working in the life sciences industry who are involved in product presentation and promotional content
Course Director: CAROLYN TROIANO
Carolyn Troiano has more than 30 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 worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.