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
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
Strategic ways to build your professional brand
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Rewiring Your Emotional Triggers: Leading with Clarity and …
AI Fundamentals for All Leaders and Managers: How to Work S…
H-1B Visa Updates and Employer Strategies for 2026
The $1M Mistake: EEOC Discrimination Claims Employers Make …
Using Claude in Excel for Productivity, Automation & Data A…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Bootcamp for New Managers and Supervisors: Develop These Es…
ChatGPT Jumpstart From intro to Download to Personal Assist…
HIPAA Compliance in 2026 — Practical Strategies for Breach …
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Why EBITDA Doesn't Spell Cash Flow and What Does?
Secrets Of Psychology - Why People Do The Things They Do
FDA Regulation of Artificial Intelligence/ Machine Learning
FDA Compliance And Laboratory Computer System Validation
Utilizing HR Metrics to Illustrate & Improve Human Resource…
ChatGPT for CPAs and Finance Professionals
Understanding EBITDA – Definition, Formula & Calculation
The 60 Minutes Introduction to DAX
The Anti-Kickback Statute: Enforcement and Recent Updates
Analytical Method Validation Under Good Laboratory Practice…
Using High-Performance Coaching for Managers to Address Per…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Workplace Investigations 101: How to Conduct your Investiga…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
THE NEW I9 - Mandated Requirements for Worker Verification …
Language is Code - Intro to AI - Generative AI - ChatGPT an…
Discover how Emotional Intelligence turns AI from a technic…
AI in B2B Marketing: What Your Compliance Team Needs to Know
Stress, Change And Team Resilience Through Humor: An Intera…
Effective And Defensible Documentation Of Employee Problems…
How to Write Procedures to Avoid Human Errors