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
Construction Lending And Real Credit Administration: Evalua…
Dealing With Difficult People: At Work & In Life
Claude AI For CPAs & Finance Professionals: Best Practices …
Secrets Of The Staffing Fix - Solving The Employee Training…
Mastering the Prompt: How Every Professional Can Use AI to …
Using Copilot to Format Legal Documents in Microsoft Word
Setting SMART Goals & Leveraging Storytelling for Reporting
Eliminate Harmful And Unproductive Drama In The Workplace
Discover how Emotional Intelligence turns AI from a technic…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Introduction to Microsoft Power BI Dashboards
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
Major cGMP Issues: FDA Concerns in 2026
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
6-Hour Virtual Boot Camp on Microsoft Power BI
Managers/Supervisors: New Role, Same Team - How to Lead Wit…
HR Auditing - New Update on Important Issues for 2026
2-Hour Virtual Seminar on In-Person Onboarding Your New Hir…
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Managing Toxic Employees: Strategies For Leaders To Effecti…
Creating Employee Handbooks that Protect You and Support th…
Female to Female Hostility @Workplace: All you Need to Know
Project Management for administrative professionals
Tools for New Managers: Connecting with Employees to Optimi…
Launch Your Career: The Ultimate Guide for Emerging Profess…
California Meal and Rest Breaks: What You Don't Know Can Co…
Managing Difficult Employee Conversations
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Practice Safe Stress ™: Preventing Burnout While Building R…
Rewiring Your Emotional Triggers: Leading with Clarity and …
AI, Jobs, and Skills: How HR Leaders Can Prepare Now for th…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Pivot tables beginner to advanced + 20 advanced Pivot table…