The Dynamic Duos. Designing a successful testing plan for PFS & AI Combination Products

The Dynamic Duos. Designing a successful testing plan for PFS & AI Combination Products

Prefilled Syringe (PFS) and Autoinjector (AI) combination products (i.e., prefilled with a drug/biologic) require a variety of tests to secure regulatory approval for market-ready use. From running multiple tests simultaneously to discovering pitfalls for your PFS or AI combination product, we partner with you to develop test design strategies to mitigate risk, secure regulatory approvals, and ensure safe and effective patient use.

During this webinar you will learn:

• Regulatory standards governing PFS and AI testing
• Test plan design strategies to support design verification and lot release
• How understanding user capabilities and user expectations impact studies and design
• The role human factors activities play in risk mitigation, usability, and patient safety