Become Specialized with Advertising, Promotion, and Labeling FDA Compliance – Training Bundle

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Product ID: 706842

Location
  • Duration: 4 Hrs
RECORDED TRAINING

 

$899.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Federal regulation of advertising, labeling, and promotion reflect an aggressive approach on the part of the FDA. Employers seek the guidance of regulatory affairs professionals for all promotional materials within a collaborative cross-functional team. This necessitates regulatory affairs professionals to be well-versed in legal and regulatory obligations.

What's at risk if the marketing and promotion efforts violate the law? Massive fines and criminal liability including the possibility of prison time; and significant operational disruption while dealing with federal investigations into illicit marketing.

ComplianceOnline has engaged elite experts and ex-FDA officials to provide detailed knowledge in the pharma advertising, labeling, and promotion for you and your team through the following training bundle.

This bundle is suitable for both new and seasoned APL regulatory affairs professionals who want to learn how to improve their ad/promo regulatory affairs communications.

See what’s covered in the training bundle

The Importance of Packaging and Labeling in Pharmaceutical Product Development
Packaging and Labeling for Commercial and Clinical Products
FDA Regulations and New Legislation for Marketing Cosmetics in the U.S
Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA

The Importance of Packaging and Labeling in Pharmaceutical Product Development

This webinar will help you succeed in pharmaceutical product launch by exploring its importance right from the conception of a product, its realization and distribution.

Areas Covered in the Webinar:

  • Regulatory Agency Requirements
  • SOPs and Change Control considerations related to packaging
  • Packaging and Labeling Interactions
  • Creation of the Package
  • Codes
  • Packaging Errors
  • Labeling Errors
  • Supply Chain Issues
  • Special Considerations (e.g. product launches, clinical vs. commercial packaging)

Packaging and Labeling for Commercial and Clinical Products

Learn how to translate a protocol into optimal package design. A review of the compliance requirements between commercial and clinical packaging and labeling will be completed.

Areas Covered in the Webinar:

  • Commercial packaging and labeling compliance (required text; prohibited text; format and layout requirements for various types of packaging and labeling; filing and approval requirements)
  • Design change control (change control review and approval process; requirements for agency approval; SOP for process; reviewing, tracking and reporting design changes)
  • Clinical packaging and labeling development and compliance (required text; format and layout requirements; considerations for blinding and global clinical trial requirements)

FDA Regulations and New Legislation for Marketing Cosmetics in the U.S

This course will help clarify what claims and product labeling are appropriate for cosmetics to market them successfully and avoid problems with FDA compliance.

Areas Covered in the Webinar:

  • Laws and Regulations Applicable to U.S. Cosmetics
  • Cosmetic Labeling Requirements
  • Adverse Event Reporting for Cosmetics
  • Cosmetic Claims and Compliance Issues
  • Current Cosmetic GMP Requirements
  • 2015 Proposed Cosmetics Legislation: The Personal Care Products Safety Act

Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA

This interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations.

Areas Covered in the Webinar:

  • Dietary Supplement Overview
    • What is a dietary supplement?
    • Supplements vs. Pharmaceuticals/OTC Drugs/Conventional Foods.
  • Regulatory Structure
    • FDA Structure regarding Dietary Supplements.
    • Industry Groups.
  • History of Dietary Supplement Regulation
    • Early History & DSHE.
    • Code of Federal Regulations.
  • Manufacturing/Distributor Considerations
    • Company & Facility Registration.
    • GMP Requirements.
  • Dietary Ingredients
    • What qualifies as a dietary ingredient?
    • Old dietary ingredients vs. New dietary ingredients.
    • New Dietary Ingredient Notification (NDIN).
    • Updated New Dietary Ingredient Guidance from FDA.
  • Labeling Considerations
    • Display Panels & Layout.
    • Supplement Facts Panel Requirements.
    • Labeling Claims.
    • Health vs. Disease vs. Structure/Function claims.
    • Disclaimers/Substantiation.
    • Notification of labeling claims to FDA.
    • Dietary Supplement Labeling Act.
  • Advertising Considerations
    • FDA vs. FTC jurisdiction & enforcement.
    • Expressed vs. Implied Claims.
    • Disclosures & Claim Substantiation.
    • Testimonials.
  • Current Events
  • Questions & Answers.
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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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