Packaging and Labeling in Pharmaceutical Product Development - Best Practices

Packaging and labeling link a product's conception to its realization and distribution, and they are central to regulatory compliance. Yet their importance is often underestimated during planning, leading to longer cycle times, costly errors, delayed availability or recalls.

This 90-minute pharmaceutical packaging and labeling training covers regulatory agency requirements, SOPs and change control for packaging, how packaging and labeling interact, and how the package is created, including codes.

You'll also look at common packaging and labeling errors, supply chain issues and special cases such as product launches and clinical vs commercial packaging.

• Explain the role of packaging and labeling in product development
• Apply regulatory agency requirements to packaging and labeling
• Use SOPs and change control to manage packaging changes
• Prevent common packaging and labeling errors
• Anticipate obstacles from marketing, medical affairs, regulatory, legal or QA

• Regulatory agency requirements
• SOPs and change control for packaging
• How packaging and labeling interact
• Creating the package
• Codes
• Packaging errors
• Labeling errors
• Supply chain issues
• Special considerations: product launches and clinical vs commercial packaging

Understanding where packaging and labeling sit in the wider development process helps you avoid delays and noncompliance and anticipate obstacles from marketing, medical affairs, regulatory, legal or QA.

The session suits operations, regulatory, packaging, labeling, QA, production control, engineering, project management and sales and marketing teams.

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

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.