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User Requirement Specification (URS) to Operational Qualification (OQ) Live Virtual Training
11/29/2023
10:00 AM - 3:00 PM EST

Event Description

User Requirement Specification (URS) to Operational Qualification (OQ) Live Virtual Training

  • How to create a robust URS  
    • Highlight both major and minor attributes of a URS 
  • How to design and implement your OQ process  
    • Highlight the design qualification tests 
    • Execution of an OQ protocol 
    • Documentation  
      • Test Protocols and Reports 
      • Temperature Recording Device Settings
      • Operational SOP/WIs 
      • Staff training 
      • How to select and implement a pre-qualified shipper 
    • Navigating Change Control to Implement your Qualified System 
    • Lessons Learned on Implementing a Qualified Shipping System 
    • Case Studies 

Instructor:

  • Carolyn Williamson, Parenteral Supply Chain; ISTA Pharma Committee Board Member

Schedule:

  • Instruction: 10:00am – 3:00pm EST
  • Break for Lunch: 12:00pm – 1:00pm EST

Rates to attend:

  • ISTA Member Discounted Rate: $495
  • Non-Member Rate: $625