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 the 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 can lead to unnecessary increases in cycle time or cost, delays in product availability possibly leading to reduced sales, or product recall due to non-compliance.
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.
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.
Upon completion of this webinar, you’ll be able to:
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 the 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 can lead to unnecessary increases in cycle time or cost, delays in product availability possibly leading to reduced sales, or product recall due to non-compliance.
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.
Why you should 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.
Upon completion of this webinar, 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 in the Session:
- 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
Speaker
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 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 organizations GMP Training Educators Association and Association for GXP Excellence (AGXPE) and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.
