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
Effective And Defensible Documentation Of Employee Problems…
Stress, Change And Team Resilience Through Humor: An Intera…
2026 EEOC & Employers: Investigating Claims of Harassment …
Burnout to Fired-up : Recognizing and Preventing Burnout in…
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Be a Better Leader: Dealing with your Inner Control Freak, …
Project Management For Administrative Professionals
HR Metrics and Analytics 2026- Update on Strategic Planning…
The Emotionally Intelligent Manager: Thriving Under Pressure
AI, Jobs, and Skills: How HR Leaders Can Prepare Now for th…
ChatGPT and Project Management: Leveraging AI for Project M…
GROUPBY and PIVOTBY functions. Pivot table killers?
Stop Letting That Difficult Person Ruin Your Day: Effective…
Launch Your Career: The Ultimate Guide for Emerging Profess…
Recruiting Top Talent in a Digital Era
Copilot and HR: An Introduction for HR Professionals
The Importance of the first 5 seconds when presenting
How to Write Procedures to Avoid Human Errors
Microsoft Excel - Data Validation Techniques
Using Claude in Excel for Productivity, Automation & Data A…
AI for Excel Professionals: Enhancing Productivity with Cha…
2026 Form I-9 Changes & New ICE Penalties: What Every Emplo…
Human Factors Usability Studies Following ISO 62366 and FDA…
FDA Compliance for Regulated Systems using COTS, Cloud, and…
Implementing an Effective Succession Plan to Identify, Deve…
ChatGPT for HR - Build HR Policy Framework and Strategy
Boost Financial Analysis with Claude in Excel
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…