Pharmaceutical and Medical Device Consultant; Blood and Plasma Processing

Technical Consultant #886

Pharmaceutical and biotechnology quality assurance and control (QA, QC.)
Regulatory compliance, consent decree and FDA batch record reviews-investigations; European audits.
Plasma and blood collection centers and computerized donor record files.
Blood and plasma quality assurance and control.
Pharmaceutical QC methods development and review.
Pharmaceutical validation of laboratory methods.
Quality systems, quality control laboratory and development of standard operating procedures.
Regulatory compliance audits; quality system audits.
Vaccine stability, raw materials, filling and packaging.
Pilot plant operations and scale-up.
Viral testing methods.
Analytical chemistry: HPLC, GC-MS, NMR, optical rotation, IR and analytical biochemistry.
Protein chemistry, peptide mapping and amino acid analysis.
Biotechnology methods: Immunochemistry, monoclonal antibodies.
Glycochemistry, algae and plant derivatives.
Preparations of IND and NDA files.

Undisclosed Company, Owner and Principal, 1998 - Present

Independent biotechnological consultant for pharmaceutical companies. Major projects and clients:

MEDIcept, Inc., Ashland, MA

Auditing and remediation of Talecris Plasma collection centers prior to FDA inspection and certification; audited numerous centers around the U.S.
Performance verification of a new computer based DMS (Donor Management System) and its equivalence to with the older 'Manual' plasma collection system.

Quantic Regulatory Services, Livingston, NJ

Wyeth Pharmaceuticals: Pre-Approval Inspection (PAI) Readiness for a new oral contraceptive tablet.
Celgene Corp: Assessed and closed all open and overdue Investigations.
Schering-Plough: Projects subject to the consent decree with the FDA.
Reviewed and certified all cGMP investigations for the laboratory and manufacturing deviations.
Performed batch release reviews for finished products with emphasis on analytical chemistry.
Pharmaceutical and biotechnology quality assurance and control (QA, QC.)
Plasma and blood collection centers and computerized donor record files; blood and plasma quality assurance and control.
Vaccine stability, raw materials, filling and packaging.
Viral testing methods.
Analytical chemistry: HPLC, GC-MS, NMR, optical rotation, IR and analytical biochemistry.
Protein chemistry, peptide mapping and amino acid analysis.
Biotechnology methods: Immunochemistry, monoclonal antibodies.
Glycochemistry, algae and plant derivatives.

Stelex Inc., Senior Consultant, Bensalem, PA

Ortho Biotech

Universal Health Watch, Inc., Columbia, MD, 1998

Immunodiagnostic developer of a rapid blood test for HIV.
Organized clinical trials at Haeneman University Hospital using blood samples from the American Red Cross.
Testing data filed in a PMA to FDA.
Organized a strategy meeting with the head of the Israeli FDA.

American Red Cross (ARC), Philadelphia National Testing Laboratory

Officer of Quality Assurance & Regulatory Affair
Worked at largest blood testing laboratory in U.S.A., subject to consent decree with the FDA.
Established and managed the QA Department, hired and trained QA associates.
Implemented a new cGMP and QC program for finished pharmaceuticals, approved by FDA-CBER.
Reviewed, approved and audited all lab operations including viral testing, blood typing, sample management, training, customer services, documentation, validations and deviations.
Coordinated annual inspections by FDA-CBER.
Twice achieved the National QA honor-roll record for low (<2) FDA-483 observations.

Academic and Professional Affiliations

President (Honorary) , US-Israel Biotechnology Council (USIBC), Rockville, MD.
Bureau of Israel's Chief Scientist, with a mission to create alliances in Biotechnology
Research Associate positions at Universities and Academic Institutes in USA and Israel.
3-year Army service in the IDF Israel Defense Forces; 25-year reserve service.
Sergeant Paramedic in the Medical Corps of the Armored Corps.

Publications