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.
WHY SHOULD YOU ATTEND?
Understanding the packaging and labeling process in the larger product development process will provide you 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 Labeling’s role in product development
- Ensure adherence to regulatory agency requirements
- Anticipate potential obstacles in marketing, medical affairs, regulatory, legal or quality assurance
WHO WILL BENEFIT?
- 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
Understanding the packaging and labeling process in the larger product development process will provide you an advantage in achieving success.
- 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)
- 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
- 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
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. 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 …
Upcoming Webinars

How to Write Contracts for Procurement Professionals

Impact Assessments For Supplier Change Notices

Stay Interviews: A Powerful Engagement and Retention Tool


Harassment, Bullying, Gossip, Confrontational and Disruptiv…


FDA Regulation of Artificial Intelligence/ Machine Learning





FORM I-9 2022: ICE Announces New Extension Date and Require…

Establishing a Robust Supplier Management Program

Three Key Risk Assessments in Your ERM Program - ERM IT and…

With Mandatory Paid Leave Gaining Ground, Is It Time To Do …

Project Management for Non-Project Managers

Travel and Expense Policy Development and Automation

Utilizing HR Metrics to Illustrate & Improve Human Resource…


Implementing an Effective Human Error Reduction Program


How to prepare an effective audit manual for an internal au…


CMO Supplier Quality Agreements: How to Comply with new FDA…

Form 1099 Update 2022: Latest Forms, Rules and Reporting Re…

21 CFR Part 11 - Compliance for Electronic Records and Sign…

Managing Toxic & Other Employees Who have Attitude Issues

The Importance of Packaging and Labeling in Pharmaceutical …

I-9 Audits: Strengthening Your Immigration Compliance Strat…


Building a World Class Accounts Payable Operation: P2P, AP

The Top Ten Excel Functions Everyone Should Know
