The Importance of Packaging and Labeling in Pharmaceutical Product Development

Pharmaceutical companies face growing regulation while also needing to work more efficiently, launch faster, cut costs, innovate and keep both patients and the business compliant. This 60-minute pharmaceutical packaging and labeling training shows where packaging and labeling fit in that picture.

Packaging and labeling bridge the gap between a product's concept and its distribution, and they are central to regulatory compliance. You'll review regulatory agency requirements, SOPs and change control, how packaging and labeling interact, package creation and codes, and common packaging and labeling errors.

The session also covers supply chain issues and special cases such as product launches and clinical versus commercial packaging.

• Explain the role of packaging and labeling in product development
• Ensure adherence to regulatory agency requirements
• Anticipate obstacles in marketing, medical affairs, regulatory, legal or quality assurance
• Work effectively with contract manufacturers and packagers
• Manage labeling in foreign languages
• Avoid unnecessary production costs, backorders and recalls, especially at launch

• Regulatory agency requirements
• SOPs and change control for packaging
• Packaging and labeling interactions
• Creating the package
• Codes
• Packaging errors
• Labeling errors
• Supply chain issues
• Special considerations such as product launches and clinical versus commercial packaging

Packaging and labeling are often underestimated, especially during planning, leading to longer cycle times, costly errors, delayed availability or recalls for noncompliance. Understanding the process within wider product development gives you an advantage.

It suits marketing, project management, operations, regulatory affairs, packaging and labeling, quality assurance, production control, packaging engineering, R&D and sales professionals.

• 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

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. He collaborated in the development and implementation of the training portion of the Consent Decree workplan for Johnson & Johnson Consumer Healthcare and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, product security, and sustainable packaging.