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

Wednesday, November 28, 2018

1:00 PM - 2:30 PM

1:00 PM - 2:30 PM See all dates and Times

https://bit.ly/2yWVPxm


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.
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
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

WHO WILL BENEFIT
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


For more detail please click on this below link:
https://bit.ly/2RKJh39


Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882



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