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FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective

Start Date:
Thursday, 7 December, 2017
End Date:
Friday, 8 December, 2017 6:00pm
Oncology, Dermatology, Nephrology, Neurology, Gastroenterology, Immunology, Pain Management, Psychiatry

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 marketHelp prevent misleading claims by tobacco product manufacturersEvaluate the ingredients of tobacco products and how they are madeCommunicate the potential risks of tobacco productsWe 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 ActExtension of FDA oversight to Vapor, e-Cigarette, Cigar and other industriesDetails of the August 8, 2016 FDA RegulationPMTAs and RequirementsHow to Build a Compliance StrategyMinimizing Cost while Maximizing ComplianceIndustry Best PracticesKnowing the policies and procedures that must be developed and maintained to support the clinical trial system in operationUnderstanding how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial systemKnowing 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 ActExtension of FDA oversight to Vapor, e-Cigarette, Cigar and other industriesDetails of the August 8, 2016 FDA "Deeming" RegulationPre-Marketing Tobacco Application (PMTA) SubmissionFDA Oversight and Compliance StrategyComputer System Validation (CSV) and the System Development Life Cycle Methodology (SDLC)Cost vs.

CompliancePolicies and ProceduresLeveraging VendorsIndustry Best PracticesFDA Trends Agenda:Day 1 Schedule Lecture 1:FDA Tobacco Regulation Overview - 2009Lecture 2:FDA's "Deeming" Regulation - August 08, 2016Lecture 3:FDA Regulatory Oversight and Compliance StrategyLecture 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 CategorizationLecture 3:System Operations and Governance: Maintaining the Validated StateLecture 4:Compliance Support: Policies, Procedures and Training SpeakerCarolyn TroianoIT 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 PMVenue: 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: $1,495.00Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt 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- Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}


DoubleTree by Hilton San Diego Downtown 1646 Front St,
San Diego,

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
Event Manager

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