Greg Fallon

I worked in R&D performing experiments, lab maintenance, organization, and calibration of equipment. I wrote SOPs, Validation protocols, deviations, OOS investigations, and Note to Files. I performed operation qualification and design of experiments for two products and was involved in the Research and Development of those two products. I personally reviewed OQ and DOE documentation for GDP GLP and GMP requirements in order to sign off the batch records. I wrote three regulatory documents for the submission of a product and an interim stability report in response to questions from the FDA. I was involved in Quality control testing of raw materials for release for GMP, and also finished product release testing.

Ran experiments using NMR, to qualitatively and quantitatively determine the presence of and the exact amount of an analyte in an unknown solution.