FDA's Recent Regulation on the Use of Social Media

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Listen from Carolyn Troiano industry reviewer for 21 CFR Part 11, the FDA’s (ER/ES) regulation. along with computer system validation and risk management/compliance at a number of Fortune 100 firms."

21 CFR Part 11 (electronic records/ electronic signatures)

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

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    Understand FDA’s current thinking, as expressed in three draft guidance documents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
•     And much, much more…

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

•     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 computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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