David E. Wiggins
|David E. Wiggins; Sr. Associate Director of Analytical Development, Bayer Consumer Care|
is Sr. Associate Director of Analytical Development for Bayer Consumer Care with responsibility for pre-market stability, analytical method validation and method transfer.
Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for Method Optimization, Method Validation, Method Transfer and Stability (both pre- and post-market). These responsibilities have additionally included involvement with multiple NDA submissions and FDA general and PAI inspections.
Mr. Wiggins has over 30 years experience in the pharmaceutical industry in both a QC and an R&D setting. During this time, he has been instrumental in establishing and updating stability and method validation policy to be consistent with the changing regulatory requirements. Mr. Wiggins has frequently lectured on stability and analytical method validation in the US, Puerto Rico, and throughout Europe. He has been active in submitting comments and validated stability-indicating analytical methods to the U.S. Pharmacopeia and has been an invited speaker to FDA, university, and industry conferences.