Validation Protocols for Analytical Equipment (935)
Expertise
Quality review of QC stability files and stability protocols for a pre-BLA drug product. Trending and analysis of stability data for annual reports.
Validation protocols for HPLC, UV-Vis spetrophotometer, particle size analyzer, and atomic absorption instruments.
Validation master plan writing and implementation
Connetics, Inc., Palo Alto, CA
Experience
Connetics, Inc., Palo Alto, CA
AeroGen, Inc., Sunnyvale, CA
Proctor & Gamble Pharmaceuticals, Norwich, NY
Wrote and executed packaging and bottling line validation protocols.
Cohesion Technologies, Palo Alto, CA
Wrote and executed validation protocols for analytical equipment (Densitometer and UV-Vis).
VALIDATION SPECIALIST
Alza Corporation, Vacaville, CA
Wrote and executed validation protocols for fluid bed granulators, tablet presses, laser drills, drying ovens, and printers used in the mfg. of extended release tablets.
Also wrote and executed validation protocols for extruders, form-fill-seal machinery, laminators, mixers, and packaging lines used in the mfg. of transdermal products.
Wrote and executed cleaning and process validation, including Nitrogen and Helium systems.
Supervised mfg. of process validation lots for international product transfer.
ANALYTICAL CHEMIST
Alza Corporation, Vacaville, CA
Proficient in the use of liquid and gas chromatography analytical equipment (HPLC and GC).
Performed batch release assays for transdermal and oral tablet products
Honors & Publications
American Society for Quality
International Society of Pharmaceutical Engineers
Education
B.S., Biochemistry, Mathematics, Western Washington University, 1994
CONTINUING EDUCATION:
Accounting, Econ, & Business Law classes at Solano Community College (96-98)
ISPE Validation Seminars, SF Bay area (1997-present)
HVAC Design, UC Santa Cruz extension, Santa Clara, CA (2000)
Project Management course, UC Berkeley (present)