User Requirement Specification (URS) to Operational Qualification (OQ) Pre-Forum Training
1:00 PM - 5:00 PM Central
Event Registration
Event Description

User Requirement Specification (URS) to Operational Qualification (OQ)

The instructors for this training will be ISTA Pharma Committee members & industry leaders Carolyn Williamson and Eric Silberstein. 

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

Lunch and break schedule:
  • Lunch: Noon – 1:00pm
  • Mid-afternoon break: 3:00pm – 3:30pm
Eric Silberstein - eBiotech Consulting, LLC, Principal
Carolyn Williamson - Parenteral Supply Chain, President

Marriott Marquis Houston
Houston, TX

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