Drugs and biologic products are rapidly evolving, and container closure designs must be more innovative than ever before. With the rise in home healthcare, container closure systems cannot be viewed as an isolated sub-assembly; they are an integral part of a product system and should be a consideration early in the drug development process.
The 2018 PDA Container Closure Performance and Integrity Conference takes place June 13-14 in Bethesda, MD. The conferenceprovides a forum where attendees can broaden their understanding of holistic requirements related to performance and protection by identifying potential failure modes throughout the life of a product, and de-risking container closure design during development.
Talks cover a wide range of topics, including best practices for container closure design, container closure integrity testing, system engineering approaches for performance optimization, critical secondary/tertiary packaging and cold chain development, and regulatory requirements in the combination product platform space.
Learning Objectives
Upon completion of this Conference, you will be able to:
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Describe the complex and intrinsic interactions among container closure, drug product formulation, and delivery system in combination products
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Delineate protection and performance risks and potential failure modes throughout product lifecycle
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Explain the FDA interpretation of protection and performance requirements to ensure patient safety and efficacy
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Summarize the rationale for required testing of combination products, container closure systems, and/or delivery devices
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Discuss the importance of ongoing industry initiatives, such as PQRI, PDA, and others
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Recognize system engineering-based approaches to identify and fulfill design requirements for container closure systems
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Identify available resources for combination product and container closure testing
For more information or to register, visit PDA’s event site here.
