FDA's Latest Regulations 2017 - FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016

Course "FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
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 San Diego, CA area.
Location: San Diego, CA Date: December 7th & 8th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA
Price:
Price: $1,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
Register now and save $200. (Early Bird)
Until October 20, Early Bird Price: $1,295.00 From October 21 to December 05, Regular Price: $1,495.00
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
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