User Requirement Specification (URS) to Operational Qualification (OQ) Pre-Forum Training
Date/Time
5/1/2023
12:00 PM - 5:00 PM Central
Event Registration
Event Type(s)
User Requirement Specification (URS) to Operational Qualification (OQ)
Event Description

User Requirement Specification (URS) to Operational Qualification (OQ) Pre-Forum Training

The How of Cold Chain – Taking the fundamentals of the first class and putting it into practice 

  • 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 
Additional fee to attend. Registration is available through the Forum registration. Registration includes lunch and break.

Instructors:
  • Eric Silberstein, eBiotech Consulting; ISTA Pharma Committe Member
  • Carolyn Williamson, Parenteral Supply Chain; ISTA Pharma Committee Board Member
Schedule:
  • Lunch: Noon – 1:00pm CST
  • Instruction: 1:00pm – 3:00pm CST
  • Mid-afternoon break: 3:00pm – 3:30pm CST
  • Instruction: 3:30pm – 5:00pm CST
Rates to attend:
With Forum Registration:
  • ISTA Member Discounted Rate: $450
  • Non-Member Rate: $575
  • ISTA Member Discounted Rate | Both Introduction to BioPharma Cold Chain AND URS to OQ: $850
  • Non-Member Rate| Both Introduction to BioPharma Cold Chain AND URS to OQ:: $995
Without Forum Registration:
  • ISTA Member Discounted Rate: $495
  • Non-Member Rate: $625
  • ISTA Member Discounted Rate | Both Introduction to BioPharma Cold Chain AND URS to OQ: $950
  • Non-Member Rate| Both Introduction to BioPharma Cold Chain AND URS to OQ: $1200
Location
Marriott Marquis Houston
Houston, TX

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5/1/2023  


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