Worst Case Package and Product Selection for Design Verification  

Selecting the correct worst-case package design is a critical step in developing an efficient, compliant package verification and validation program. In this webinar, DDL Principal Engineer Jay Zaki explains the requirements of ISO 11607 and provides a practical framework for identifying the most challenging package configuration for testing.

Key points covered in this webinar include:

• ISO 11607 requirements for worst-case package selection
• The difference between package verification and validation
• Defining primary, secondary, and tertiary packaging
• Key attributes to evaluate when selecting a worst-case package, including dimensions, mass, device geometry, and package configuration
• How sterilization methods, sealing processes, and distribution environments impact package grouping
• Best practices for grouping similar package formats to reduce testing while maintaining compliance
• A practical example demonstrating a systematic approach to worst-case package selection

Download a recording of the webinar to learn how a risk-based approach to worst-case package selection can improve testing efficiency, strengthen validation strategies, and support regulatory compliance.

Please fill out the form to receive a copy of the webinar recording.