Pharmaceutical Consultant: Analytical Methods Validation, Computer Systems Validation and QA/QC

Expertise

• Analytical Techniques: GC, HPLC, GC/LC/MS, FTIR, UV-Vis.
• Stability-indicating method development, validation and transfer.
• Analytical equipment validation: IQ, OQ, PQ.
• Part 11 compliance and GAP analysis.
• Validation master plan development.
• Stability protocol development.
• CTD dossier preparation.
• Cleaning validation strategy.
• LIMS and Laboratory Data Acquisition Computer systems.
• Coumadin, Percodan, Naloxone, Numorphan and Naltrexone .
• Software Applications: Documentum, Trackwise, ISOtrain, ERP/MRP, EDMS, Maximo.
• Computerized systems validation deliverables: UFRS, CRS, FAT, SAT, IQ/OQ/PQ, RTM, VSR.
• Preparing compliance documents, SOP's, validation and CMC stability summary reports.

Experience

Independent Consultant, New York, 2002 - Present

• Created Module 3 CTD Dossiers for registering OTC products in new overseas markets.
• Prepared CTD GAP analysis for needed materials for drug substances and excipients.
• Provided QA/QC for clinical documentation by revising and editing PK/PD reports CTD module 5 and 2 clinical sections for an NDA registration package.
• Audited LC/MS method validations in support of clinical trials testing and documenting risk assessments in response to FDA warning letters.
• Prepared, executed and conducted reviews of CSV deliverables including compliance assessments, corrective action plans, CSV and SLC documentation, test scripts, test summary logs, and validation summary reports for computer system validation.
• Conducted audits for GMP operational compliance and development of responses to FDA compliance problems, notices of observations, warning letters and consent decrees.
• Subject matter expert on computer system validation for Part 11 issues.

Emisphere Technologies, Inc., Tarrytown, NY Associate Director, Quality Support Services 2000 - 2002

• Managed operations of a quality control unit including the GMP laboratory documentation control and stability.
• Designed new analytical testing laboratories in conjunction with facilities expansion.
• Prepared commissioning and validation documentation for major laboratory equipment upgrade.
• Approved all IQ/OQ/PQ validation protocols and executed protocols for CGMP compliance.
• Authored compliance documents, stability reports for CMC sections, SOP's specification documents and certificate of analysis ( COA's ), stability portions of the CMC section for NDA filings.
• Prepared out of specification (OOS ) investigation reports, GLP toxicology sample analysis summary reports, and reporting of clinical pharmacokinetic data.
• Completed computer validation report for laboratory Turbochrom workstation.

G&W Laboratories, Inc., R&D Manager, South Plainfield, NJ, 1997 - 2000

• Managed operations of an R&D lab with for new semi-solid OTC product development.
• Prepared cleaning validation master plan for all products to adequately address warning letter deficiencies which resulted in product withdrawals.
• Prepared 13 product cleaning validation protocols and authored all reports within 6 months without any FDA 483 observations upon re-inspection.
• Investigated vendors and coordinated demonstrations of new laboratory chromatography data systems to comply with up-coming 21 CFR Part 11 requirements.

Clay-Park Labs, Inc., Laboratory Manager, Bronx, NY, 1995 - 1997

• Managed new semi-solid product development with contract manufacturing and research firms to ensure compliance with QC criteria, SOPs, GMPs and contractual guidelines.
• Directed the successful and on-time start-up and operation of a new R&D lab for semi-solid generic, OTC and cosmetic new product development.
• Wrote 25 SOPs and trained staff to rectify all laboratory FDA 483 compliance observations.
• Conducted training on CGMPs and new revised SOPs.
• Authored, published and validated HPLC methods for Nitrofurazone products in USP PF.

Other Positions

• DuPont Merck Pharmaceutical Co., Technical Support, Garden City, NY, 1990 - 1994
• Pall Corporation, Laboratory Manager, Glen Cove, NY, 1989 - 1990
• Pepsico, Inc., Senior Chemist, Valhalla, NY, 1987 - 1989
• Lederle Labs, Development Chemist, Pearl River, NY, 1986 - 1987
• Revlon Health Care, Senior Chemist, Tuckahoe, NY, 1981 - 1986
• Chemtech Consulting Group, Inc., Group Leader, New York, NY, 1980 - 1981
• Equitable Environmental Health, Inc., Analytical Chemist, Woodbury, NY, 1979 - 1980

Education

Ph.D., Organic Chemistry, Polytechnic University, Brooklyn, NY

M.S. Geochemistry, Rensselaer Polytechnic Institute, Troy, NY

B.S., M.A., Chemistry, Queens College, Flushing, NY