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Packaging and Labeling in Pharmaceutical Product Development - Best Practices

  • By: Michael Esposito
  • Recorded Session
  • Duration: 90 Minutes
  • Training Level: Intermediate to Advanced
  • Email Reminder

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Recorded Session

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OVERVIEW

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
     

SPEAKER PROFILE

Michael Esposito

Michael Esposito has 30 years experience in the pharmaceutical industry and 13 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil 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 McNeil and revised their introductory GMP course. He is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.

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
     

SPEAKER PROFILE

Michael Esposito

Michael Esposito has 30 years experience in the pharmaceutical industry and 13 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil 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 McNeil and revised their introductory GMP course. He is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.

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