FDA`s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016 2017 is a course that covers topics such as:
- 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
FDA`s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016 2017 brings together:
- Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
- FDA Tobacco Control Act
- Pre-Marketing Tobacco Application (PMTA) Submission
- 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
