Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
FDA Tobacco Control Act
PMTAs and Requirements
Details of the August 8, 2016 FDA Regulation
Minimizing Cost while Maximizing Compliance
How to Build a Compliance Strategy
Knowing the policies and procedures that must be developed and maintained to support the clinical trial system in operation
Industry Best Practices
Knowing about FDA trends in oversight and audit and how to keep abreast of these
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
Who should Attend
Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
Details of the August 8, 2016 FDA "Deeming" Regulation
Computer System Validation (CSV) and the System Development Life Cycle Methodology (SDLC)
FDA Oversight and Compliance Strategy
Policies and Procedures
Cost vs. Compliance
Industry Best Practices
Leveraging Vendors
FDA Trends
Past Events
FDA`s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016 2017 - 07-08 Dec 2017, DoubleTree by Hilton Hotel San Diego Downtown, California, United States (71628)
Important
Please, check "FDA`s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016" official website for possible changes, before making any traveling arrangements