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

Presenter:

	Sunny J. Modi, Ph.D. Director, Package Testing Eurofins Medical Device Testing
Dr. Sunny J. Modi is a Director of Package Testing for Eurofins Medical Device Testing with 10 years of experience focusing on creating and testing packaging materials. He specializes in transport simulation, shelf life, and mechanical testing with a thorough understanding of ASTM, ISTA, and ISO testing standard for package integrity testing. Dr. Modi participated in the technical review committee for International Safe Transit Association (ISTA) and a member of Institute of Packaging Professionals (IoPP) and the Association for the Advancement of Medical Instrumentation (AAMI). Dr. Modi earned his Ph.D. and M.S. degrees from The Ohio State University focusing in packaging and composite applications.
	Corinna Proctor Senior Technical Director Eurofins Human Factors MD
Corrina Proctor is a Senior Technical Director for Eurofins Human Factors MD with more than 20 years of experience focusing on human factors testing. Her work includes authoring use-related risk analyses, protocols for human factors studies, moderating human factors studies of combination products or devices under simulated, but realistic use conditions with recruited/intended users, contributing to residual risk analyses, authoring human factors engineering reports, and assisting clients through regulatory questions related to HF programs. Ms. Proctor has an MS in Cognitive Psychology from NC State University.