August 28, 2014
Regulatory agency in search of New Technologies from Lives International
August 28, 2014
Regulatory Agency in search of New Technologies from Lives International – a Real Time Loggers Training at FDA in Octomber 21st, 2014
October 21st, 2014
Mr. Sorin Haias
Lives International Corp.
3, rue Jules Guesde
F – 92300 Levallois-Perret
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 OCtomber 21, 2014. My division is responsible for the review of information submitted in support of biologics license applications and supplements, and this includes ares such as lyophilization, sterilization, depyrogenation, cold storage, shipping. You provided a very useful summary of your 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 processed which have been validated and/or monitored with you 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.
John A. Eltermann, Jr., R.PH., M.S.
Division of Manufacturing and Product Quality
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research