Developing a Working User Requirement Specification (URS)

Wednesday, December 04, 2024  |  9:00 AM EST / 15:00 CET

This session will equip pharma, life science, healthcare, medical device and logistics industry professionals with the knowledge and skills needed to create effective User Requirement Specifications (URS). It will also include a LIVE Q&A segment.

The discussion will be led by industry expert and ELPRO GxP Validation/Qualification Engineer Marisa Remsing, who brings several years of experience in qualification and regulatory compliance. She will be joined by ELPRO Validation/Qualification Engineer Steph Punter of ELPRO Services Inc. and Dirk Raubald, Janssen Advanced Therapies Supply Chain EMEA.  

What You Can Expect to Learn:

> How to create your own URS document
> The definition and purpose of a URS
> Regulatory requirements for URS
> Application of the V-model in URS development
> Four key steps to URS success
> Common pitfalls to avoid in URS creation
> Best practices for URS development
> Practical insights through a real URS example