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FDA's Latest Regulations for Computer Systems Used in the Tobacco and Relat...

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Courtyard by Marriott Richmond Downtown

1320 East Cary Street

Richmond, VA 23219

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Description

*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
REGISTER TODAY!

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



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


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.


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS ALLOWED ON REGISTRATIONS
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Date and Time

Location

Courtyard by Marriott Richmond Downtown

1320 East Cary Street

Richmond, VA 23219

View Map

Refund Policy

No Refunds

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