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


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      December 7, 2017

      Thursday   9:00 AM - 6:00 PM (daily until December 8, 2017)

      1646 Front St, San Diego, CA 92101, USA
      San Diego, California 92101

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      EVENT DETAILS
      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.
      For More Information- https://www.globalcompliancepanel.com/control/sponsorship

      Contact us today!

      NetZealous LLC DBA GlobalCompliancePanel
      john.robinson@globalcompliancepanel.com
      support@globalcompliancepanel.com
      Toll free: +1-800-447-9407
      Phone: +1-510-584-9661
      Website: http://www.globalcompliancepanel.com

      Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901294SEMINAR?eventful-December-2017-SEO

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      Cost: Payment required - 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)

      Categories: Education | Health & Wellness | Technology

      This event repeats daily until December 8, 2017: Dec 7, Dec 8

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.
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