User Requirement Specification (URS) to Operational Qualification (OQ) Pre-Forum Training
Date/Time
5/1/2023
1:00 PM - 5:00 PM Central
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
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
Location
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