CC 301 | User Requirement Specification (URS) to Operational Qualification (OQ)Pre-Forum Training
Date/Time
4/22/2024
1:00 PM - 5:00 PM Pacific
1:00 PM - 5:00 PM Pacific
Event Registration
Event Type(s)
URS to OQ
Event Description
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
Additional fee to attend. Registration is available through the Forum registration. Registration includes lunch and break. This course qualifies for 20 points towards ISTA PDP recertification.
This course will be instructed by industry expert and ISTA Pharma Committee Officer, Carolyn Williamson.
Schedule:
- Lunch: Noon – 1:00pm
- Instruction: 1:00pm – 3:00pm
- Mid-afternoon break: 3:00pm – 3:30pm
- Instruction: 3:30pm – 5:00pm
Rates to attend:
With Forum Registration:
- ISTA Member Discounted Rate: $450
- Non-Member Rate: $575
- ISTA Member Discounted Rate | Both Introduction to BioPharma Cold Chain AND URS to OQ: $850
- Non-Member Rate| Both Introduction to BioPharma Cold Chain AND URS to OQ: $995
Without Forum Registration:
- ISTA Member Discounted Rate: $495
- Non-Member Rate: $625
- ISTA Member Discounted Rate | Both Introduction to BioPharma Cold Chain AND URS to OQ: $950
- Non-Member Rate| Both Introduction to BioPharma Cold Chain AND URS to OQ: $1200
Location
Outlook/vCalendar/Google
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| 4/22/2024 |    |
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