Rapid Sterility Testing for Short-Life Pharmaceuticals: USP-1071
DATE & TIME
10 May 2019 Friday, at 10.30 AM Singapore Time
(Duration : 90 mins)
Dr. Tony CUNDELL
Dr. Tony Cundell has co-chaired the USP Expert Panel that published a draft guidance document USP-1071 concerning Rapid Sterility Testing of Short-Life Products: A Risk-Based Approach. This document follows publication in late 2017 of a stimuli article The Development of Compendial Rapid Sterility Tests.
Tony will address the definition of shelf-life medicinal products and the challenges they pose in relation to traditional pharmcopoeial sterility tests. He will share insights into the USP process that has delivered recommendations concerning suitable technologies for rapid sterility testing, and review the advantages and disadvantages of the recommended technologies for this application.
Dr. Tony Cundell consults in the pharmaceutical industry in the areas of microbial risk assessment, regulatory affairs, and microbiological testing.
Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, Tony Cundell worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.
He is a member of the 2015-2020 U.S.P. Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods.
Tony Cundell has a Ph.D. in Microbiology from the Lincoln University, New Zealand.