The Importance of Packaging and Labeling in Pharmaceutical Production – Best Practices

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

ebinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"Michael Esposito has over 30 years experience in the pharmaceutical industry and 17 years experience in GMP training and document management"

Unnecessary increases in cycle time, costly errors, delays in product availability, or product recalls

Description

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 an advantage in achieving success.

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
•     Work effectively with contract manufacturers or packagers
•     Manage labeling in foreign languages
•     Avoid unnecessary production costs, back orders and recalls, especially during product launches

Areas 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)

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

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Michael Esposito

Michael Esposito has over 30 years experience in the pharmaceutical industry and 18 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 is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, product security, and sustainable packaging.

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