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FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

Event Details

FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

Time: November 28, 2018 from 1pm to 2:30pm
Location: Training Doyens 26468 E Walker Dr
Street: 26468 E Walker Dr,Aurora, Colorado
City/Town: Aurora
Website or Map: https://bit.ly/2Qx64iN
Phone: +1-720-996-1616
Event Type: online
Organized By: Training Doyens
Latest Activity: Nov 8, 2018

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Event Description

OVERVIEW

An effective and compliant strategy is critical to any FDA-regulated organization, including those in the tobacco-related industries. Knowing the FDA tobacco regulation is the first step toward ensuring compliance, and learning about industry best practices is a sure way to learn how to balance compliance with cost.

WHY SHOULD YOU ATTEND

This webinar that discusses FDA deeming regulation is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

AREAS COVERED

Topics covered include:

  • 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
  • Compliance Strategy
  • Cost vs. Compliance
  • Computer System Validation (CSV)
  • Industry Best Practices
  • Policies and Procedures
  • Leveraging Vendors
  • FDA Trends
  • Best Practices

LEARNING OBJECTIVES

  • FDA Tobacco Control Act and “Deeming Rule”
  • Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
  • Details of the August 8, 2016 FDA Tobacco Regulation
  • PMTAs and Requirements
  • How to Build a Compliance Strategy
  • Minimizing Cost while Maximizing Compliance
  • Industry Best Practices 
  • Know the policies and procedures that must be developed and maintained to support the clinical trial system in operation

Industries:

  • Tobacco
  • e-cigarettes
  • e-liquids (vapors)
  • Cigars
  • Smokeless/Pouch Tobacco

Positions:

  • Information Technology (IT) Analysts
  • IT Developers
  • IT Support Staff
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Quality Managers, Chemists and Microbiologists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders using Computer Systems regulated by FDA
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries

 

 For more detail please click on this below link:

https://bit.ly/2RKJh39

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

 

 

 

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