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This session equips pharma, life science, healthcare, medical device and logistics industry professionals with the knowledge and skills needed to create effective User Requirement Specifications (URS). It also includes a live Q&A segment.
The discussion was led by industry expert and ELPRO GxP Validation/Qualification Engineer Marisa Remsing, who brings several years of experience in qualification and regulatory compliance. She was accompanied by ELPRO Validation/Qualification Engineer Steph Punter of ELPRO Services, Inc., and Dirk Raubald, Advanced Therapies Supply Chain EMEA, Johnson & Johnson Innovative Medicine.
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 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 |
This session was 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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