Dr. Claudia Spanier

• functional and disciplinary power to direct the associated employees • Overview, analysis and optimization of process performance of soft shell manufacturing processes • Process validation • PQR preparation and assessment • Risk analysis (FMEA)

I perform Continuous Process Verification for pharmaceutical products. This inlcudes risk-based identification of Critical Quality Attributes in the production process of each product, respective statistical evaluation of IPC and release data, identification of shifts, drifts, trends and unusual values, assessment of the impact of the validation state and definition and supervision of measures, if necessary.

I am responsible for PQR preparation and assessment. I was also part of supplier qualification with raw material risk assessments, supplier and manufacturer audit management and risk analysis. I was also part of customer audit management. I also took part in raw material documentation and quality assurance agreement management for customers and supplier/manufacturer. I also prepared and reviewed associated SOP and managed customer communication regarding PQR and supplier qualification.

Pharmaceutical guidance Emergency service

• Pharmaceutical consultation and related commercial tasks • Drug substitution • Retirement home provision • Pharmaceutical emergency service

Pharmaceutical guidance Emergency service

Educational supervision of pharmacy students in drug analysis (focus areas: fluorescent measurement techniques and narcotics theory and analysis)

Pharmaceutical guidance Emergency service

Pharmaceutical research (cell membrane-located purinergic ion channels using fluorescent measurement techniques and radioligand-binding studies) Educational supervision of pharmacy students in drug analysis (focus areas: fluorescent measurement techniques and narcotics theory and analysis)

Clinical Pharmacy Platin-based cytostatics Tyrosinkinase-Inhibitors Evidence-based medicine Radioactive diagnostics Biosensor Analysis