Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
What Regulatory, Quality & Compliance Professionals Need to Know
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
Webinar Takeaways
- 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- Understand FDA’s current thinking, as expressed in three draft guidance documents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
Overview
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..
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.
Faculty 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