Franklin Spriggs, Ligand Binding Assay Group Leader; Ashley Brant, Program Manager, AIT Bioscience||January 28, 2016 The success of bioanalytical studies relies on the selection of the most suitable analytical method but the timeline of method development and types of analyses involved vary greatly.
Dave Rottjakob, Deborah Ensign, Shawn Sherry, and Kate Bloomrose||September 8, 2014 Unfortunately, most manufacturers wait until after a 483 or performance problem to revisit qualification practices. Proactive testing and continued monitoring ensure patient safety and compliance
Daniel L. Prince, Ph. D., Christopher J. Waskewich, M.S., Kristah J. Kohan, B.S. and Danina G. Rinaldi, B.S. , Gibraltar Laboratories, Inc.||March 7, 2014 An opinion on the microbial limit test with reference to harmonization.