User Requirement Specification (URS) to Operational Qualification (OQ) Live Virtual Training
Date/Time
1/23/2023
10:00 AM - 3:00 PM Eastern
10:00 AM - 3:00 PM Eastern
Event Registration
Event Description
User Requirement Specification (URS) to Operational Qualification (OQ) Live Virtual Training
Break for Lunch from 12:00pm-1:00pm
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
Instructor:
Carolyn Williamson - ISTA Pharma Committee Board Member, Parenteral Supply Chain, President
Rates to attend:
ISTA Member Discounted Rate: $495
Non-Member Rate: $625
Location
Live Virtual Training
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