Expertise DescriptionI have more than 35 years experience in the Pharmaceutical and Pharmaceutical Packaging industries. I have extensive experience in the areas of Laboratory Management and Food and Drug Administration Regulations. My experience also includes various technical management positions in Quality Control, Technical Service, Labeling, and as a Director of Research and Development in Pharmaceutical Packaging. I have over 10 years expert witness experience.
Areas of Expertise
My expert witness experience includes patent infringement cases.
My consulting services include regulatory experience: Food and Drug Administration Compliance; Prepare submissions to the FDA; Prepare or review Drug Master Files; Quality Audits and Implementation Changes; Establish quality assurance procedures; Corrective Action, Preventative Action (CAPA) compliance including Root Cause Analysis; Training Programs. My technical experience includes: Design or review existing laboratory procedures; Selection and Testing of Rubber Stoppers and Plastic and Glass Components; Various aspects of lyophilization; Design procedures for Raw Material, In-Process, and Finished Product release testing. My management experience includes: Work Flow Design and Strategic Planning. My project experience includes: Conducted management review of supervisory persons; Assisted in establishment of forensic program for generic drug use to ensure regulatory compliance.
I am knowledgeable about the FDA patent approval process. I also have my own patents and therefore am familiar with the patent approval process.
At the FDA I was the Laboratory Director. At times, when the District Director was away from the office I was Acting District Director. In each capacity I interacted heavily with Headquarters.
In fact I was assigned a one month "detail" at Headquarters, during which time I participated in many meetings there including drug approval meetings.
I know the mechanism of how a drug is approved.
I am knowledgeable on how one goes about getting FDA approval of medications; what investigations and/or testing the FDA would conduct.
My time in the pharmaceutical industry includes employment with the FDA.
I also worked for a brief assignment at Headquarters during which time I learned more about how the FDA works.
|B.A.||Chemistry||La Salle College||Philadelphia|
|M.S.||Physical Chemistry||Saint Joseph's College||Philadelphia|
|M.B.A.||Marketing and FInance||Temple City University||Philadelphia|
Awards & Affiliation
Partial List of Consulting Expert Witness Cases