Trends in FDA Compliance for Regulated Computer Systems in the Tobacco Industry

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By 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."

FDA’s authority to include the regulation of electronic nicotine delivery systems

Description

he Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (water pipe) tobacco, pipe tobacco and nicotine gels, among others. The rule went into effect on August 8, 2016.
This action is a milestone in consumer protection – going forward, the FDA will be able to:
•      Review new tobacco products not yet on the market
•      Help prevent misleading claims by tobacco product manufacturers
•      Evaluate the ingredients of tobacco products and how they are made
•      Communicate the potential risks of tobacco products
We will provide an overview of the regulations as they pertain to the manufacturing, marketing, distribution and other operational activities engaged by companies in the tobacco industry.
This course will describe the best practices for developing a compliance strategy, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.

Areas Covered

This webinar will provide key information about the following areas:
•        FDA Tobacco Control Act
•        Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
•        Details of the August 8, 2016 FDA Regulation
•        PMTAs and Requirements
•        How to Build a Compliance Strategy
•        Minimizing Cost while Maximizing Compliance
•        Industry Best Practices
•       Knowing the policies and procedures that must be developed and maintained to support the clinical trial                     system in operation
•       Understanding how to leverage the vendor and other external resources to apply the best industry practices                and avoid potential pitfalls when validating a clinical trial system
•        Knowing about FDA trends in oversight and audit and how to keep abreast of these

Who will Benefit

•        Professionals in the following industries may also benefit from the content:
•        Pharmaceutical
•        Medical Device
•        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
•         Anyone involved in the planning, execution, and reporting of a clinical trial (sponsor, director, researcher,                   regulatory role, etc.)

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . 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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