ISTA CC 301 | User Requirement Specification (URS) to Operational Qualification (OQ) 

Date: Wednesday, October 14 
Time: 10:00 a.m. to 2:00 p.m. ET (UTC-04:00) 
Instructor: Carolyn Williamson, ISTA Pharma Committee Board Member 

Course Overview 
Learn how to develop, qualify, and implement a temperature-controlled shipping program from User Requirement Specification (URS) through Operational Qualification (OQ). This course takes the fundamentals of ISTA CC 201 and puts it into practice. 

Course Topics 
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, including: 

  • 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 Rates 
ISTA Member Rate: $495 
Non-Member Rate: $625 

Instructor 
Carolyn Williamson has 20 years’ experience in supply chain qualification spanning the development and commercial components in both pharmaceutical and biologics space. Carolyn has been active in this space within the industry throughout her career and currently is serving on the ISTA Pharma Committee Board. Carolyn transferred her career to a consulting role in 2019 as President of Parenteral Supply Chain offering her the freedom to work on every aspect of the supply chain from Mile 1 to the Last Mile. Carolyn is certified as a Project Management Professional. She holds a B.S. degree from The Catholic University of America and an M.B.A. degree from LeMoyne College.  

ISTA PDP Recertification Credit: 20 points 
 

Students may optionally register for PDP 101 for $75 USD.


CC 201 | Introduction to BioPharma Cold Chain & CC 301 | URS to OQ