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

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.