Cold Chain (CC)

We’re excited to announce the following Cold Chain courses developed by industry experts to advance education in the cold chain space.  These courses provide an in-depth look at the supply chain for temperature sensitive products and detail industry best practice guidance authored by ISTA's Pharma Committe

In-Person Training at the 2023 ISTA Forum | TransPack & TempPack: Our first two cold chain courses will be offered as In-Person Trainings at upcoming ISTA events.  Please look forward to more Online Self-Study and Live Virtual Training versions of this curriculum!


CC 201 | Introduction to BioPharma Cold Chain

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

Choose How You Want to Learn

You choose how you want to learn. Whether you prefer the flexibility of learning on your own or the interactivity of a live course (virtual, or in-person), ISTA offers the best options to suit your learning style. Plus, you can choose any combination.

Live Virtual Training

Instructor-led, real-time training in a virtual environment.

Get in-depth training by attending our scheduled virtual course trainings which features our instructor who walk through subject matter via a live video conference call. Virtual opportunities are scheduled throughout the year.

  • New event dates just added!
View events

In-Person Training

Face-to-face training at ISTA events.

Interactive live events with our lead instructor and fellow attendees with our in-person events such as the annual ISTA Forum, TransPack & TempPack events.

  • Member discounted rate: $495
  • Non-member rate: $625

Discounts offered with event registration and if taking multiple courses.

  • New 2023 Forum training events just added!
View events

Non-Member Access

ISTA Educational courses are now available for non-members. Click below to learn more about signing up for a non-member access account.

Non-Member Access

Course Descriptions

CC 201 | Introduction to BioPharma Cold Chain

The instructor for this training is ISTA Pharma Committee Board Member Carolyn Williamson.

The Who, What, Why and Where of a Temperature-Controlled Shipping Program

  • Basics of a cold chain program 
  • Attributes of a gold standard cold chain program 
  • Guiding standards for the industry 
  • Introduction to the Shipping Qualification Process Flow 
  • Lessons learned on selecting test labs and suppliers (labs, packaging, recording devices, etc.)

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

The instructor for this training is ISTA Pharma Committee Board Member Carolyn Williamson. 

The How of a Temperature-Controlled Shipping Program

  • 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

Continuing Education

In addition to these Cold Chain courses, ISTA continues efforts to build out an expanded list of educational courses including the new revamped Packaging Dynamics Professional (PDP) certification program. Some courses can be completed for credit towards PDP recertification.  Content offerings include:

Group Training

Ramp up your team's skills in a cost-effective way, by having our instructor conduct training (virtual or in-person) for your group. Contact us at and we'll follow up, answer any questions and help bring continuing education to your organization.