Seminar to help you understand compliant packaging and labeling process in the larger product development from conception of a product to its realization and distribution. Get equipped to reduce cycle time, avoid costly errors and delays, or product recalls.

Pharmaceutical and life sciences companies are under an extreme amount of pressure to maintain an ever-increasing amount of regulation and legislation. With this pressure, they still need to increase efficiencies, bring new products to the market faster, reduce prices, deliver innovation, ensure patient compliance, and maintain business compliance.

Packaging and Labeling activities are crucial. They should comply with regulatory agency requirements. They form a bridge between the conception of a product and its realization and distribution. Still, their importance is often underestimated, especially in the planning phases, which leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. Understanding the packaging and labeling process in the larger product development process will provide you an advantage in achieving success.

Learning Objectives:-

• Articulate Packaging and Labeling’s role in product development
• Ensure adherence to regulatory agency requirements
• Anticipate potential obstacles in marketing, medical affairs, regulatory, legal or quality assurance
• Work effectively with contract manufacturers or packagers
• Manage labeling in foreign languages
• Avoid unnecessary production costs, back orders and recalls, especially during product launches

Areas Covered:-

• 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)
• Knowledge assessment

Agenda:-

DAY 01(11:00 AM - 6:30 PM)

• 11:00 AM -12:00 PM:
  • Seminar objectives review, expectations and scope.
  • nterview attendees re their specific responsibilities and needs
  • Agreement on focus
• 12:00 PM -01:00 PM:
  • Regulatory requirements for packaging and labeling: FDA packaging regulations, FDA labeling regulations, FDA packaging regulatory requirements, FDA labeling regulatory requirements
  • SOPs and Change Control considerations related to packaging: What commitments you make when you put your process in writing
  • Consequences of noncompliance
• 01:00 PM -02:00 PM:
  • Packaging and Labeling Interactions
  • Packaging and Labeling workflows
  • Review/knowledge check
• 02:00 PM -03:00 PM: Lunch
• 03:00 PM -04:00 PM:
  • Creation of the Package: bill of materials, packaging component specifications, CAD drawings, materials, dimensions, folds, quiet areas, packaging line trials
  • Unique identifiers (package, component numbers)
• 04:00 PM -05:00 PM:
  • Codes - introduction
  • Customer codes - types, positioning on components
  • Company codes - types, positioning on components
• 05:00 PM -06:00 PM:
  • Verification of codes on packaging equipment
  • Product security considerations
• 06:00 PM -06:30 PM: Knowledge check for day

DAY 02(11:00 AM - 6:30 PM)

• 11:00 AM -12:00 PM:
  • Seminar objectives review, expectations and scope
  • Review of Day 1 topics, feedback and conclusions
• 12:00 PM -01:00 PM:
  • Labeling creation process
  • Printed component types and considerations
  • Serialization requirements
  • Interaction with printers
• 01:00 PM -02:00 PM:
  • Effects of Packaging and Labeling on:
    • Production
    • Warehousing and distribution
    • Consumer use of product
  • Knowledge check
• 02:00 PM -03:00 PM: Lunch
• 03:00 PM -04:00 PM:
  • Packaging and Labeling errors
  • Level of gravity of error depending on when it occurs
  • Packaging and Labeling review of errors
• 04:00 PM -05:00 PM:
  • Supply Chain issues
  • Product launches
  • Clinical vs. commercial packaging
  • Role play for a product launch
• 05:00 PM -06:00 PM:
  • Course review: overall impact of Packaging and Labeling in pharmaceutical production
  • Questions and feedback
• 06:00 PM -06:30 PM: Knowledge assessment

Who will Benefit:-

Pharmaceutical industry, particularly those areas that develop packaging for the manufacturing of pharmaceutical products (Product Development, Production Planning, Manufacturing, Quality Assurance)

This course will be of benefit to anyone who is a stakeholder in product launches, revisions to pharmaceutical labeling and packaging, or timely delivery of product, including

• Marketing
• Project Management
• Operations
• Regulatory Affairs
• Labeling and Packaging
• Quality Assurance
• Production Control
• Packaging Technology
• Labeling Coordination
• Package Engineers
• Packaging Operations
• Sales and Marketing
• Quality Assurance