Kevin R. Smith
- Role
- Esperion
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Kevin R. Smith
I am a Pharmaceutical QC and Analytical Development Improvement Expert with deep…
Experience
Present
Education
Binghamton University
Doctor of Philosophy (Ph.D.), Chemistry
Binghamton University
Bachelor of Science (BS), Biochemistry
Skills
- Standard Operating Procedure (Sop)
- Analytical Method Validation
- Capa
- U.s. Title 21 Cfr Part 11 Regulation
- U.s. Food and Drug Administration (Fda)
- Analytical Methods Development
- Bpf
- Change Control
- Good Laboratory Practice (Glp)
- Quality Management
- Drug Development
- Biopharmaceuticals
- Cmc Development
- Lims
- Validation
- Clinical Development
- Quality System
- V&V
- Biotechnology
- Cross-Functional Team Leadership
- Pharmaceutics
- 21 Cfr Part 11
- Pharmaceutical Industry
- Sop
- Fda
- Corrective and Preventive Action (Capa)
- Glp
- Computer System Validation
- Technology Transfer
- Gxp
- Regulatory Affairs
- Quality Control
- Gmp
- Regulatory Submissions
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