FDA Requirements for Packaging and Labeling
Table of Contents

• FDA's Organization and Role
• FDA's Regulation of Prescription Drug Marketing & Promotion
• The Advertising & Promotional Labeling Branch (CBER Part 1)
• CBER's Advertising & Promotional Labeling Branch (Part 2)
• DDMAC Update – Regulation of Prescription Drug Promotion
• Developing a Worldwide Product Labeling System
• Regulatory Requirements for Prescription Drug Labeling: The Bulk Container, The Package, The Cartons
• Complying with FDA's Requirements for Packaging and Labeling
    °Fundamentals of Pharmaceutical Packaging and Labeling
    °cGMPs for the Manufacturing, Packaging and Labeling of Drug Products
    °Composition and Manufacturing of Drug Packaging Materials
    °Implementing Comprehensive SOPs for Packaging and Labeling
    °IQ/OQ/PQ Acceptance Criteria for Packaging and Labeling Equipment
    °Format and Styles of Packaging and Labeling to help Reduce
• Complying with Legal Requirements for Labels and Labeling Processes
    °Implementation Strategies that Target Safety and Prevention of Liability Issues
    °Ensuring that Outsource Packaging and Labeling Suppliers comply with FDA Requirements
    °Implementing Formal Quality Test Procedures and Criteria
    ° Implementing Clinical Protocol Requirements for Packaged and Labeled Products
• Pharmaceutical Drug Packaging: The FDA's Current Focus
• Preparing for a Pre-Approval Inspection
• US Packaging and Post-Approval Changes (PACPAC)    <more>