who should
attend?
LEVEL
IntroductoryThis course is intended for professionals in the Pharmaceutical or Biological industries who are responsible for either the establishment or approval of drug product specifications within a regulated environment.
Individuals within the following areas will benefit from this course:
– R&D
– Quality Control
– Quality Assurance
– Technical Operations
– Manufacturing
In addition, individuals within Regulatory Affairs who often review these documents will benefit from this training.
This training is Part One of a 10-course series required for the GMP Laboratory Control Professional Certification Program.
Click the image below to learn more about this Certification Program.
David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation and method transfer.
Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. 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, ANDA submissions and FDA general and PAI inspections.
Mr. Wiggins has over 35 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.