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
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.
- 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 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
- 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. 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

Leadership: Strategic Planning and Decision Making

The Top Ten Excel Functions Everyone Should Know


2-Hour Virtual Seminar on How to Conduct an Internal Harass…

2025 Handbook Overhaul: Navigating Critical Updates! Federa…


3-Hour Virtual Boot Camp on Easier Excel Automation with VB…

Outlook - Master your Mailbox - Inbox Hero Inbox Zero


Empowering Conflict Resolution: Letting Go to Gain Control


Retention Starts Here: Stop Losing Your Critical Talent and…


Gossip-Free: Leadership Techniques to Quell Office Chatter

California Meal and Rest Breaks: What You Don't Know Can Co…

Managing Difficult Employee Conversations


Harassment, Bullying, Gossip, Confrontational and Disruptiv…

Managing Toxic Employees: Strategies For Leaders To Effecti…

Workplace Investigations 101: How to Conduct your Investiga…

Copilot and HR: An Introduction for HR Professionals

Excel Power Skills: Master Functions, Formulas, and Macros …



6-Hour Virtual Seminar on Learning the Highlights of Excel …

Bootcamp for New Managers and Supervisors: Develop These Es…

Stress, Change And Team Resilience Through Humor: An Intera…


Is Your Workforce Change Ready? A Leader’s Guide to Quickly…