Packaging and Labeling in Pharmaceutical Product Development – Best Practices

Webinar Compliance, Online Event
2020-10-22

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 an advantage in achieving success.

Learning Objectives:

• After completing this course, you’ll be able to:
• 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

Michael Esposito

Michael Esposito has 30 years experience in the pharmaceutical industry and 13 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations.

He collaborated in the development and implementation of the training portion of the Consent Decree workplan for McNeil and revised their introductory GMP course. He is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.