This event has completed.

1/23/2023
10:00 AM - 3:00 PM EST

User Requirement Specification (URS) to Operational Qualification (OQ)
Monday, January 23, 10:00am – 3:00pm 
Break for Lunch from 12:00pm-1:00pm

The instructor for this training will be ISTA Pharma Committee Board Member & industry leader Carolyn Williamson. 

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:
Carolyn Williamson - Parenteral Supply Chain, President

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

You are invited to a Zoom Webinar:

Name: User Requirement Specification (URS) to Operational Qualification (OQ) 
Date/Time: 01/23/23 10:00 AM
Time Zone: Eastern

To Join the Webinar:
https://us02web.zoom.us/j/88396053467?pwd=REpjMUgrbWdXRWlIWWtiOUREbUNLUT09

Webinar ID: 88396053467

Webinar Password is Required: ista

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