Analytical Development, Validation, Compliance:
Analytical development, protein chemistry, enzyme activity assays, Taqman qPCR.
Assay refinement, evaluating critical parameters, robustness testing.
Assay validation, instrument validation.
Validation protocol, validation report.
Development and validation of Excel spreadsheets for automatic data analysis.
Data models, 4-parameter parallel line analysis, nonlinear least squares analysis.
Virus plaque assay, endpoint dilution infectivity assay, potency assays.
Control charting, statistical process control, analysis of stability data.
SAS, MiniTab, nonlinear least squares analysis.
Robustness testing, design of experiments, Plackett-Burman.
Database and Data Management:
SQL*LIMS, SQL Server, Microsoft Acess, database design.
Software User Requirements, implementation, validation.
Document and Technical Reports electronic control systems.
Design of relational tables, forms, reports.
ODBC extraction of data into SAS, Excel, etc.
Out of Specification Test Results:
OOS, OOT workflow.
Retesting strategies and statistical analysis.
Investigation SOP's, strategies.
OOS tracking, Corrective actions tracking.
42 Seabreeze Dr.
Richmond, CA 94804
telephone: (510) 235-7657