Event Registration - International Safe Transit Association
This event has completed.

Developing Thermal Data Analysis Standards: Algorithms for Developing Temperature Test Profiles from Ambient Lane Data Webinar
11/14/2018

Event Description
Wednesday, November 14th 1:30-2:15pm EST

Bernard McGarvey, Ph.D. 
Retired
Engineering Fellow at Eli Lilly and Company


Paul Harber
Founder
Parental Supply Chain
 

Development of thermal testing profiles using data collected from various lanes is a common practice in the pharmaceutical industry. These thermal profiles are used in chamber testing of shipping containers. Currently the available standards emphasize the use of a standard test profile. This presentation argues that we now need to begin to identify standard algorithms for developing test profiles as well. This will allow shippers to develop test profiles form their own sourced data. In particular, this presentation describes the QT(min/max) method for developing thermal profiles and demonstrates how it is superior to several existing methods that are currently in use.
 
This method is a critical element in an overall risk analysis for evaluating the suitability of pre-qualified passive container solutions. Additionally, this method can be utilized to compare thermal profiles irrespective of the method used to create them. The integration of this method with thermal modeling simulations of passive container solutions is also considered.

Bernard McGarvey Biography: Education: B.E. and Ph.D. in Chemical Engineering, University College Dublin, Ireland. Activities: Focus over the last 15 years has been on the application of first principles thinking to solving problems in the pharmaceutical industry. Most recently he has applied this to cold chain transportation to improve the speed and quality of the decision making required to optimize cold chain distribution. Professional Achievements: Retired as an Engineering Fellow at Eli Lilly and Company.

Paul Harber Biography: Paul Harber is founder of Parenteral Supply Chain, LLC. PSC, as it is known, collaborates with clients devoted to all facets of the distribution of parenteral products. He is the ISTA Pharma Committee Chair. He was a founding member of the PDA Pharmaceutical Cold Chain Interest Group. Paul co-authored for the Parenteral Drug Association (PDA) Journal of Pharmaceutical Science and Technology Technical Report No. 39 (PDA TR#39). PDA TR#39 is widely used by both industry professionals and regulators as the definitive reference source for best-demonstrated practices in transport validation. Paul continues to serve on the PCCIG steering committee and regularly presents at the annual PDA meetings. Paul has contributed numerous articles on a variety of subjects related to cold chain including Stability Studies for Transportation. For 20 years the scope of Paul’s work at Eli Lilly and Company focused on the qualification of both active and passive shippers in support of clinical and commercial transportation of temperature labile products. He had major roles in defining and specifying the cold chain components and practices necessary to support the commercialization of four Lilly products worth over two billion in annual sales.


 
Registration Rate: $55   ISTA Member Discounted Rate: $0
You must be registered by 11:30am (EST) on November 14th to participate.
MEMBERS: You must use your personal login to receive the Member Discounted Rate.  If you use the Company login, the package will be unavailable.