Pharmaceutical and Medical Device Consultant; Blood and Plasma Processing

Technical Consultant #886


Expertise

  • 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.

Experience

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

  • Software Validation and Development services to pharmaceutical companies.

Ortho Biotech

  • Validation of NCRS; Electronic system for managing GMP errors and deviations.
  • Developed testing protocols for IQ, OQ & PQ stages.

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.

Honors & Publications

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

  • Principal author of 25 publications in peer reviewed scientific journals.
  • 11 conference abstracts.
  • Scientific Publications (Available Upon Request)

Education

  • Ph.D. Biochemistry, Weizmann Institute of Science, Rehovot, Israel
  • M.Sc. Physical Chemistry, Hebrew University of Jerusalem
  • B.Sc. Chemistry and Physics, Hebrew University of Jerusalem
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