FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016 Seminar

Global Compliance Seminars

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.

Course Description

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, 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.

Why you should attend

This seminar 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

Areas Covered in the Session:

This course includes the following key areas of learning:

FDA Tobacco Control Act
Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
Details of the August 8, 2016 FDA "Deeming" Regulation
Pre-Marketing Tobacco Application (PMTA) Submission
FDA Oversight and Compliance Strategy
Computer System Validation (CSV) and the System Development Life Cycle Methodology (SDLC)
Cost vs. Compliance
Policies and Procedures
Leveraging Vendors
Industry Best Practices
FDA Trends

Agenda:

Day 1 Schedule

Lecture 1:

FDA Tobacco Regulation Overview - 2009

Lecture 2:

FDA's "Deeming" Regulation - August 08, 2016

Lecture 3:

FDA Regulatory Oversight and Compliance Strategy

Lecture 4:

Pre-Marketing Tobacco Application Process (PMTA)

Day 2 Schedule

Lecture 1:

"GxP" Computer System Validation (CSV) and the System Development Life Cycle Methodology (SDLC)

Lecture 2:

Validation Planning: Risk Management and GAMP 5 System Categorization

Lecture 3:

System Operations and Governance: Maintaining the Validated State

Lecture 4:

Compliance Support: Policies, Procedures and Training

Speaker;

Carolyn Troiano

IT Program Manager and FDA Compliance Consultant, Smart Resources, Inc.

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.

Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

More Seminar Information

Global Compliance Panel
Summary	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.
Delivery Method	Seminar
Who Should Attend