Kevin Bosman 46 connections

I have been working as a consultant in pharmaceutical chemistry for much of the past ten years. My knowledge of GLPs, GMPs, and what the FDA is looking for in a validated assay or process has been my main "selling point." Some of that experience came about the hard way, having experienced FDA audits regarding compliance and validation issues and written and implemented responses to EIR and 483 observations

My activities have included analytical method development and validation for various laboratory techniques. I have also performed activities supporting the evaluation, optimization, characterization, and validation of pharmaceutical and chemical manufacturing processes. This includes cleaning validations of both dedicated and multi-use systems, no simple task, there. This production support has really been my "bread and butter," particularly over the past few years.

As part of these efforts I have written hundreds of SOPs and authorizing documents and designed and executed dozens of protocols. I have transferred processes and assays between facilities, including internationally. I have recently been heavily involved with three plants in the Carribean, one in France and one in Tunisia. Most of those efforts were designed to assure consistency between production personnel, manufacturing facilities, analysts and laboratories. I am equally at home in the lab or on the production floor, coordinating various manufacturing and laboratory protocols.

I have contributed major elements of the CMC sections of INDs, NDAs, ANDAs and amendments, assuring technical accuracy and consistency with CTDs. I recently draftied a 72 page CMC section to another NDA.