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
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
2-Hour Virtual Seminar on DeepSeek vs ChatGPT AI for CPAs a…
Construction Lending And Real Credit Administration: Evalua…
How the OBBB Act will Impact Immigration Enforcement! Preve…
Sunshine Act Reporting - Clarification for Clinical Research
FDA Regulation of Artificial Intelligence/ Machine Learning
2-Hour Virtual Seminar on Outlook - Timesaving Tips and Tri…
Leadership Upskilling: Don’t Just Manage; Lead with Influen…
Aligning Your HR Strategy with Your Business Strategy: A Ro…
H-1B Visa Updates and Employer Strategies for 2026
AI for Excel Professionals: Enhancing Productivity with Cha…
HIPAA 2025 – Major Changes, Latest Rulings & Guidance
Understanding Accounting for non - Accounting professionals
Dealing With Difficult People: At Work & In Life
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Project Management for Non-Project Managers - Scheduling yo…
ChatGPT and Project Management: Leveraging AI for Project M…
Language is Code - Intro to AI - Generative AI - ChatGPT an…
Copilot and HR: An Introduction for HR Professionals
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Excel Power Skills: Master Functions, Formulas, and Macros …
Project Management for administrative professionals