Overview:
Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution.
Their activities are also crucial for compliance with regulatory agency requirements.
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.
Why you should Attend:
Pharmaceutical and life sciences companies are under an extreme amount of pressure to comply with 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 at the forefront of this effort, as much of their activity occurs shortly before product manufacture and distribution.
Areas Covered in the Session:
- 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)
Who Will Benefit:
- 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 Consultants
- Research and Development