2022 - The Importance of Packaging and Labeling in Pharmaceutical Product Development

OVERVIEW
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.
WHY SHOULD YOU ATTEND?
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, 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 with an advantage in achieving success.
AREA 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)
LEARNING OBJECTIVES
After completing this course, you’ll be able to:
Articulate Packaging and Libeling’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, backorders, and recalls, especially during product launches
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
SPEAKER PROFILE
Michael Esposito has over 30 years’ experience in the pharmaceutical industry and 17 years’ experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer, and Johnson & Johnson's Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations.
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Email: info-AT-247compliance.us
Tel: +1-661-336-9555
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