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 Read more
Packaging and Labeling form a bridge between the conception of a product and its realization and distribution, and consequently occupy a critical position in the success or failure of any pharmaceutical product launch or revision.
Decision-makers need at least a cursory knowledge of potential pitfalls to create contingencies, as it is easier and more cost-effective to change things earlier in process than later.
The importance of Packaging and Labeling is often underestimated, especially in the planning phases, and as Packaging and Labeling tasks occur closer to the end of a product launch or revision, excess time is often spent in the earlier phases of product development and encroaches on these activities.
In addition, the types and numbers of errors that are possible at the packaging and labeling stages are greater than many people realize, and these errors in can lead to unnecessary increases in cycle time or cost, delays in product availability possibly leading to reduced sales, or product recalls due to noncompliance.
As a result, it is essential to include Packaging and Labeling in the initial stages of product and package development to avoid issues during production.
Course Objectives:
• 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
Why Should You Attend:
Packaging and Labeling occupy a critical position in the success or failure of any product launch and in the production of pharmaceuticals in general because they impact many company functions. Their activities also are crucial for compliance with regulatory agency requirements.
Still, their criticality is often underestimated especially in the planning phases, leading to unnecessary increases in cycle time, costly errors and delays in product availability. Your understanding of its importance as it relates to your own deliverables will provide you an advantage in achieving success.
Course Outline:
• Regulatory requirements
• Combination packages
• Packaging and labeling stakeholders
• Packaging and labeling's role in product creation or revision
• Printed packaging workflow
• Elements of packaging (e.g. numbers, codes)
• Packaging component types
• Packaging and labeling errors to avoid
• Supply chain issues
• Special circumstances affecting packaging and labeling activities
• Obstacles that can be overcome
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Marketing Product Managers
• Project Managers
• Operations Coordinators or Managers
• Regulatory Affairs Managers
• Labeling and Packaging professionals at all levels
• Quality Assurance Specialists or Managers Production Control
• Supervisors
Training for New Technical Writers
LIVE : Scheduled on
13-January-2025 :01:00 PM EST
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