Expert in Pharmaceutical QC and Validation Protocols for Analytical, Laboratory and Production Equipment

Technical Consultant #935


Expertise

  • Pharmaceutical and medical device process and equipment validation.
  • Pharmaceutical quality control, quality review of pre-BLA (Biologic License Application) drug product, and stability analysis.
  • Validation of HPLC, UV-Vis spectrophotometer, particle size analyzer, and atomic absorption instruments.
  • Created and wrote IQ/OQ validation protocols for sterile washers, dry heat ovens, and robotic filling and capping equipment used in aseptic manufacturing of implantable controlled release systems.
  • Executed validation protocols for fluid bed granulators, tablet presses, laser drills, drying ovens, and printers for extended release tablets.
  • Wrote validation protocols for extruders, form-fill-seal machinery, laminators, mixers, and packaging lines for the manufacture of transdermal products.

Experience

Independent Consultant, Validation Engineering, 1998 - Present

  • Quality review of quality control stability files and stability protocols for a pre-drug product.
  • Trending and analysis of stability data for annual reports.

Projects

AeroGen, Inc., Sunnyvale, CA

  • Validation protocols for HPLC, UV-Vis spetrophotometer, particle size analyzer, and atomic absorption instruments.
  • Validation master plan writing and implementation.

Alza/Sequus Pharmaceuticals, Menlo Park & Palo Alto, CA

  • Wrote and executed PQ protocols Alza's Finn Aqua autoclave.
  • Work included process development for diverse load configurations, knowledge of BI use and handling, and the operation of Kaye Digistrip data collectors.
  • Wrote and executed IQ/OQ validation protocols for sterile washers, dry heat ovens, and robotic filling and capping equipment used in aseptic manufacturing of implantable controlled release system in a Class 1000 facility.

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).

Alza Corporation, Vacaville, CA, 1994 - 1998

Validation Specialist

  • Wrote and executed validation protocols for fluid bed granulators, tablet presses, laser drills, drying ovens, and printers used in the manufacturing of extended release tablets.
  • Authored and executed validation protocols for extruders, form-fill-seal machinery, laminators, mixers, and packaging lines used in the manufacturing of transdermal products.
  • Wrote and executed cleaning and process validation, including nitrogen and helium systems.
  • Supervised manufacturing of process validation lots for international product transfer.

Analytical Chemist, 1994 - 1995

  • 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

Credentials

Continuing Education

  • Accounting, Economics and Business Law classes at Solano Community College
  • ISPE Validation Seminars, San Francisco
  • HVAC Design, UC Santa Cruz extension, Santa Clara, CA
  • Project Management course, UC Berkeley

Academic and Professional Affiliations

  • American Society for Quality
  • International Society of Pharmaceutical Engineers

Education

  • B.S. Biochemistry, Mathematics, Western Washington University
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