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
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
New EEOC Report: Workplace Harassment Prevention Not Workin…
Human Error Reduction Techniques for Floor Supervisors
21 CFR Part 11 - Compliance for Electronic Records and Sign…
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Transforming Change and Conflict into Diverse-Inclusive-Col…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Navigating 2025 Employment Laws: What Every Employer Needs …
Managing Difficult Employee Conversations
ChatGPT and Project Management: Leveraging AI for Project M…
Future Of Forecasting And Budgeting With Rolling Forecast
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Internal Controls in Accounts Payable
The FMLA - An Employer's Guide to Compliance and Employee A…
Excel Power Skills: Master Functions, Formulas, and Macros …
Develop People Intelligence: Is Your Communication Style as…
The Impact of Artificial Intelligence on Your Workforce
AI in Everyday Work – help with Microsoft products
How to Document Employee Discussions and Why it is Important
Construction Lending And Real Credit Administration: Evalua…
The Anti-Kickback Statute: Enforcement and Recent Updates
Navigating FDA Inspections: From SOP to 483
2025 EEOC & Employers: Investigating Claims of Harassment …
2-Hour Virtual Seminar on DeepSeek R1 for Business and Mark…
Risk Analysis in the Medical Device Design Process
Introduction to Microsoft Power BI Dashboards
How To Get Control of Your Day, Life & Career - Time Manage…
AI Across the Business: Practical Use Cases for Founders an…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Female to Female Hostility @Workplace: All you Need to Know
Writing Effective 483 and Warning Letter Responses
FDA Recommendations for Artificial Intelligence/Machine Lea…
Language is Code - Intro to AI - Generative AI - ChatGPT an…
Understanding EBITDA – Definition, Formula & Calculation