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26.09.2024
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 accompanied by ELPRO Validation/Qualification Engineer Steph Punter of ELPRO Services, Inc., and Dirk Raubald, Advanced Therapies Supply Chain EMEA, Johnson & Johnson.
What You Can Expect to Learn:
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How to create your own URS document
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The definition and purpose of a URS
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Regulatory requirements for URS
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Application of the V-model in URS development
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Four key steps to URS success
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Common pitfalls to avoid in URS creation
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Best practices for URS development
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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, Validation/Qualification Engineer at ELPRO
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Marisa Remsing |
Stephanie Punter |
Dirk Raubald |
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.
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