Regulatory Agency in search of New Technologies from Lives International

Regulatory Agency in search of New Technologies from Lives International - a Real Time Loggers Training at FDA in October 21, 2014

October 21, 2014

Mr. Sorin Haias
Lives International Corp.
3, rue Jules Guesde
F – 92300 Levallois-Perret
France


Dear Mr. Haias:

I’d like to express my sincere appreciation for the outstanding training seminar regarding real-time data loggers, presented by you to my division on October 21, 2014. My division is responsible for the review of information submitted in support of biologics license applications and supplements, and this includes areas such as lyophilization, sterilization, depyrogenation, cold storage, shipping. You provided a very useful summary of you company’s technology as compared to the traditional thermocouples which we often see in the course of our reviews. As a result, my staff is more prepared for future inspections and reviews that contain processes which have been validated and/or monitored with your real-time wireless technology. Understanding the technology, its capabilities, and limitations will enhance our ability to perform our jobs. The information presented was very enlightening and will surely impact our approach to temperature mapping and monitoring.

We are grateful for your time and appreciate the additional travel you incurred to visit our location. We would welcome the opportunity to work together in the future.


Sincerely yours,
John A. Eltermann, Jr., R.Ph., M.S.
Director
Division of Manufacturing and Product Quality
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

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