InnovationShare Webinar Series

Our InnovationShare webinar series will offer monthly educational sessions led by thought leaders within the cold chain industry. Each webinar series will feature key relevant topics and best practices for clinical and commercial supply chain management.

Learn more about each free webinar below and register today!

Part 2: A worked example of the methodology

Date: March 25, 2021
Time: 11:00AM EST
Presenter: Bernard McGarvey, Ph.D., Parenteral Supply Chain
  • Use a made up set of ambient shipment profiles
  • Analysis looking for outlier profiles
  • Calculation of QT metrics
  • Defining the QT acceptance criteria
  • Define the baseline test profiles
  • Analysis of spikes and dips
  • Defining the final test profiles

About the Speaker


Bernard McGarvey, Ph.D.

Parenteral Supply Chain

Bernard McGarvey retired as an Engineering Fellow at Eli Lilly and Company at the end of 2017. He has a B.E. and Ph.D. in Chemical Engineering from University College Dublin, Ireland. He spent 34 years working for Eli Lilly and Company at various locations in Ireland and the USA. He has held a variety of roles in process control and process engineering over this time, as well as time in corporate manufacturing.

His main interest is in the application of First Principles thinking to improve engineering decision making and problem solving at Eli Lilly, covering both process development and manufacturing. Towards the end of his career he has applied this approach to pharmaceutical cold chain distribution leading to improvements in both the speed and quality of decision making in this area.

He currently provides technical support in the area of cold chain at Parenteral Supply Chain, Inc.,

GDP Update -The Importance of Self Auditing

Date: April 21, 2021
Time: 11:00AM EST
Presenter: Steve Jacobs

Self-Inspections are an integral aspect of the Good Distribution Practices (GDPs). Too many folks think that third party inspections are enough to ensure GDP compliance. While helpful, they cannot replace self-inspection protocols. Even though self-inspections are required for GDP compliance, many regulators find that they are either not carried out or are insufficient in their scope.

What you will learn:

  • Explain the importance of self-inspection for GDPs
  • List the four parts of a great self-inspection program
  • Identify the value of a Root Cause Analysis (RCA) vs a CAPA
  • Define the areas to focus on for a good self-inspection program



Clinical Trial Regulation (CTR) and the Role of Clinical Supply Chain Transparency

Date: July 22, 2021
Time: 11:00AM EST
Presenter: Steve Jacobs

The Clinical Trial Regulation will have an impressive impact on the clinical supply chain.  It has been delayed, from its original launch date in May of 2016, and will soon become law in Europe.

The issue stemming from transparency has created a requirement to put retest dates on primary and secondary containers of Investigational Medicinal Products (IMP), required better data sharing of clinical trials and drove higher expectations of clinical supplies returns and reconciliation.

What you will learn:

  • Compare and contrast the Clinical Trial Directive with the Clinical Trial Regulation
  • Explain the impact of having to put retest dates on primary containers of IMP
  • Describe the reasons returns and reconciliation have become a key focus in the CTR