Overview: The 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. Why should you Attend: How to Build a Compliance Strategy Minimizing Cost while Maximizing Compliance Knowing the policies and procedures that must be developed and maintained to support the clinical trial system in operation Areas Covered in the Session: 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 Compliance Strategy Cost vs. Compliance Who Will Benefit: Data "Owners" Data "Stewards" Information Technology Analysts Information Technology Developers and Testers QC/QA Managers and Analysts Speaker Profile Carolyn (McKillop) 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. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: [email protected]