User Requirement Specification (URS) to Operational Qualification (OQ) Pre-Forum Training
Date/Time
5/1/2023
12:00 PM - 5:00 PM Central
12:00 PM - 5:00 PM Central
Event Registration
Event Type(s)
User Requirement Specification (URS) to Operational Qualification (OQ)
Event Description
User Requirement Specification (URS) to Operational Qualification (OQ) Pre-Forum Training
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; ISTA Pharma Committe Member
- Carolyn Williamson, Parenteral Supply Chain; ISTA Pharma Committee Board Member
- Lunch: Noon – 1:00pm CST
- Instruction: 1:00pm – 3:00pm CST
- Mid-afternoon break: 3:00pm – 3:30pm CST
- Instruction: 3:30pm – 5:00pm CST
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
- 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
Click on the icon next to the date(s) to add to your calendar:
| 5/1/2023 |    |
Email Reminder