Expert No. 343607 – GA
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Expertise Description: Pharmaceutical expert with more than 35 years experience in the Pharmaceutical and Pharmaceutical Packaging industries. Has extensive experience in the areas of Laboratory Management and Food and Drug Administration Regulations. Experience includes various technical management positions in Quality Control, Technical Service, and as a Director of Research and Development in Pharmaceutical Packaging. Additional experience as an adjunct instructor at various area colleges, teaching Physical Chemistry, Finance, and Marketing. Has authored multiple publications. B.A. in Chemistry. M.S. in Physical Chemistry. M.B.A. in Marketing and Finance. More than 10 years expert witness experience. Consultations and depositions.
Areas of Expertise:
Representative Litigation Experience:
- Patent infringement cases
Representative Consulting Services and/or Projects:
Regulatory
Regulatory
- 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
- 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
- Work Flow Design
- Strategic Planning
- Conducted management review of supervisory persons
- Assisted in establishment of forensic program for generic drug use to ensure regulatory compliance
Education:
| Degree | Subject | Institution | |
|---|---|---|---|
| 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 |
Other Career Highlights:
| Composed and presented Industry / Government Training Seminars |
| Patented a Chemical Device and Method |
| Adjunct Professor |
