Sr. Reviewer
US Food and Drug Administration
Silver Spring, Maryland
Diane Goll, Chemical Engineer, has been at FDA for 10+ years and serves as a Sr. Process, Micro and Facility Reviewer in CDERs Office of Process and Manufacturing Assessment. Prior to that, Diane completed 20+ years in late-stage formulation and process development, technology transfer and manufacturing support in regulated industries including NASA, Hoffman LaRoche, Glatt Air, Pharmacia/Pfizer and Estee Lauder/M.A.C. During her time in industry, she authored numerous publications and secured several patents in controlled release technologies. Expertise includes solid and liquid dosage forms, fluid bed technologies, establishment of quality assurance programs, SOP and cGMP training, regulatory documentation. Diane completed her Bachelor’s in Chemical Engineering from Florida Institute of Technology and did masters work at Michigan State in packaging science. Recognized for strength in leading teams. Proven coach and mentor with ability to develop employees' professional growth.
The Impact of ICH Q12 and Established Conditions
Wednesday, October 25, 2023
3:00 PM – 3:15 PM ET