User Requirement Specification (URS) to Operational Qualification (OQ) Live Virtual Training
Date/Time
12/2/2022
10:00 AM - 3:00 PM Eastern
Event Registration
Event Description

User Requirement Specification (URS) to Operational Qualification (OQ)
Friday, December 2, 10:00am – 3:00pm 
Break for Lunch from 12:00pm-1:00pm

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 

Instructors:
Eric Silberstein - eBiotech Consulting, LLC, Principal
Carolyn Williamson - Parenteral Supply Chain, President

Rates to attend:
ISTA Member Discounted Rate: $495
Non-Member Rate: $625
 

Location
Live Virtual Training
Outlook/vCalendar/Google
Click on the icon next to the date(s) to add to your calendar:
12/2/2022  


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