Qualification and Validation Webinar: How to Manage Cold Chain Qualification When Handling High Value Biologics
As cold chain and ultra cold chain logistics have become an increasingly important element in the shipping of high volume medical, biologics, and other critical biological materials. The need to create an effective strategy to ensure packaging integrity has become a topic of great interest.
Packaging qualification is an often misunderstood process that requires a good deal of experience and expertise. I have had the great pleasure to work with Praveen Bezwada-Joseph, Quality Assurance Manager on many of our biologic and cell therapy logistics qualification studies for clinical trials . Praveen is an expert in the area of both package qualification and process validation. He specializes in cold and ultra cold applications and will share his knowledge and expertise answering some of the more common questions raised in package qualification (see his recent eBook publication on Cold Chain Qualification for Biologics). On April 22, 2014, Praveen and I will be conducting a webinar: How to Manage Cold Chain Qualification When Handling High Value Biologics, where we will address the importance of an effective cold chain qualification strategy and answer some of the most common issues that are raised directly.
Qualifying your entire shipping process enhances your ability to meet regulatory requirements and achieve commercial success. If the variables that influence temperature are not taken into consideration early in planning for packaging and distribution, it can lead to problems with scalability and commercial viability, as well as potentially dire consequences such as compromising patient safety and/or shut down your clinical trial.
You will learn about:
- Ensuring temperature compliance through packaging, qualification, and process validation
- Temperature requirements (storage and handling) of high value biological materials
- Understand and protect the Last Mile from manufacturer to the patient or study participant
If you get 99 percent of your cold chain right but miss on the final one percent, you still fail, especially where cell-based products are involved. Sign up for the webinar today!
How to Manage Cold Chain Qualification When Handling High Value Biologics
Date: Tuesday, April 22, 2014
Time: 11:00 - Noon EST (USA) / 16:00 - 17:00 PM (UK)
Note: this webinar will be recorded and be available once the webinar has completed.