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



Fair Lending in 2025: New Regulations, Examinations and Enf…

I-9 Audits: Strengthening Your Immigration Compliance Strat…

Using Emotional Intelligence to Elevate Your Leadership

ChatGPT & HR: How HR Recruiting Professionals Can Leverage …

Elevate Your Workplace Wellness: 10 Critical Wellness Facto…

FDA Trends in Compliance and Enforcement in Computer System…

Tattoos, hijabs, piercings, and pink hair: The challenges …

How to Manage the Legal Landmine of the FMLA, ADA and Worke…

How to Write a Successful Job Hazard Analysis


How to Write Right for Better Business Communication

How to Prepare For and Host a FDA Inspection and Respond to…

From Good to Great: The Secrets to an Optimized LinkedIn Pr…

Public Speaking: Overcoming The Fear of Public Speaking



Transforming Anger And Conflict Into Collaborative Problem …

Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…

The Five Cs Of Commercial Credit: The Basic Elements Of Cre…

Workplace Investigations 101: How to Conduct your Investiga…

Navigating Alcohol and Drug Addiction Protections Under the…





Reduce Stress in the Workplace: Effective Ways to Handle Co…

Transforming HR with AI: Unlocking Excellence and Innovation

Creating Employee Handbooks that Protect You and Support th…

FDA Technology Modernization Action Plan (TMAP) and Impact …


Transform Data into Insights: A Beginners Guide to Excel Pi…

50+ new Excel features so far this decade

Mindful Communication:The Key to Meaningful Conversations i…


FDA Proposes Framework to Advance Credibility of AI Models

FMLA Compliance in 2025: A Comprehensive Guide & Strategies…

Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…

Hiring and Retaining Employees in this Crazy Economy

Managing Toxic Employees: Strategies For Leaders To Effecti…

Harassment, Bullying, Gossip, Confrontational and Disruptiv…