LIVE WEBINAR: Developing a Working User Requirement Specification (URS)

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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 5 years of experience in qualification and regulatory compliance. She will be accompanied by ELPRO Validation/Qualification Engineer Steph Punter of ELPRO Services, Inc.

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

A well-crafted URS is the foundation of successful GDP/GMP project implementation. We will provide attendees with practical, actionable knowledge and look at a sample URS document to help ensure their next URS development process is a success.

Marisa Remsing, Qualification Engineer at ELPRO

Marisa Remsing
GxP Validation/Qualification Engineer
ELPRO Global

Stephanie Punter
Validation/Qualification Engineer
ELPRO Services Inc.

Who Should Attend:
This session is tailored for Responsible Persons, Quality Managers, Operation Managers, Engineering Managers, and Process Managers, in the pharmaceutical, life science, healthcare, medical device and logistics industries where precise documentation of user requirements is critical.