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Pharmaceutical Laboratory Analytical Chemist: QA/QC, Validation and FDA Compliance

Technical Consultant #1166


Expertise

  • Extensive experience in pharmaceutical, nutraceutical and chemical industry analytical laboratories.
  • Laboratory management and analytical laboratory improvement, cGMP and GLP compliance and problem resolution.
  • Pharmaceutical process, cleaning and analytical methods validation.
  • Solid dosage for OTC drug products.
  • Responsibility for QA/QC functions for testing, complaint handling, customer audits and data analysis for over 300 different drug products.
  • Training on cGMP and GLP compliance and problem resolution.
  • Document writing.
  • FDA problem resolution; consent decrees.

Experience

Independent Consultant, 2003 - Present

  • Consulting on cleaning validation design and execution, including method development and validation that resulted in client going from Warning Letter to a no 483 follow-up inspection by FDA.
  • Complete overhaul of laboratory systems for a prescription drug manufacturer-regulatory and analytical.

Undisclosed Analytical Laboratories, President, 1996 - 2003

  • Managed all technical activities including analytical design, technical review, supervision of staff, document preparation and review, regulatory compliance, security and customer interaction.
  • Grew company from startup in January 1997 to a business level of about $1 million per year before sale of company to Chemir Pharma Services in July, 2003.

Independent Consultant, 1992 - 1996

  • Provided technical and laboratory management consulting services to pharmaceutical and chemical clients in the area of analytical laboratory improvement, cGMP and GLP compliance and problem resolution.
  • Conducted training activities and assisted in planning laboratory technology upgrades.
  • As a managing consultant, brought a chemistry/lab into substantial compliance for firm under FDA consent decree. Subsequent inspection by FDA yielded no 483 observations under chemistry.
  • Brought bulk pharmaceutical firm into compliance by design and implementation of a total laboratory plan that included process, cleaning and analytical methods validation. Firm went from warning list to a 483 having only three (3) minor observations. Represented firm during FDA inspection.
  • Through audit, training and use of statistical Q.C. techniques, designed and implemented a Q.C. efficiency program that resulted in a substantial yearly testing cost reduction.
  • Developed a successful lab management plan for a major pharmaceutical contract lab that resulted in improved morale, elimination of end-of-month backlogs and greater productivity.

Barr Laboratories, Pomona, New York, Director of Analytical Laboratories, 1990 - 1992

  • Responsibility for direction and maintenance of team effort in support of new product development and regulatory compliance.
  • Designed improved testing modalities for key drug products resulting in a $300,000 per year cost reduction.
  • Managed the firm out of FDA comment letter backlog, permitting faster approval for new drug products.
  • Eliminated departmental turnover through rearrangement of job assignments and realignment of responsibilities.
  • Implemented structured management of department, resulting in 100% on-time completion of both short and long-term projects.
  • Developed plan for improved operation of Q.C. department that would eliminate end of month backlogs and manage day to day priorities more efficiently.
  • Increased departmental office efficiency through the use of advanced computer technology for the management of scientific information.

Independent Consultant, 1988 - 1990

  • Management of QA/QC functions of a pharmaceutical plant handling complaints, conducted, product testing, customer audits, and data analysis for over 300 different products.
  • Designed reduced sampling-testing protocol that resulted in 1500 man-hour overtime reduction.
  • Implemented technology upgrade in Q.C. lab with 800 man-hours per year impact in labor savings.
  • Designed, wrote and implemented Q.C. management software package that standardized data analysis and reporting.
  • Package adapted at other plant sites.
  • Designed, implemented and installed telecommunications software and hardware for automatic computer-generated certificates of analysis which saved on man-day per week in clerical labor and enhanced Company's quality image.
  • Conducted a variety of technical seminars for groups ranging from senior managers to first line supervisors.
  • Strengthened market position with key accounts through direct presentation to customers.

Private Formulations, Inc. Edison, New Jersey, Director of Quality, 1986 - 1988

  • Responsible for direction of all quality control, quality assurance, analytical methods development and regulatory affairs for solid dosage, OTC drug products.
  • Launched a 10 month lab improvement program that resulted in FDA inspections going from unsatisfactory to satisfactory.
  • Introduced modern Q.A. inspection techniques that eliminated 100% product testing.
  • Computerized lab operations, installed LAN and provided training and modified MRP system software, eliminating 2-day delay moving products from Manufacturing to Shipping after lab approval.

Dynamite-Nobel, Stony Point, New York, Quality Assurance Manager, 1974 - 1986

  • Corporate Position, responsible for analytical and environmental chemistry, serving four business groups and three manufacturing sites.
  • Reorganized and upgraded Stony Point, Q.C. lab, resulting in a doubling of lab efficiency.
  • Designed Q.C. department for Mobile, Alabama plant.
  • Implemented all phases of project up to and including actual plant startup.

Honors & Publications


  • Wrote textbooks on The pharmaceutical analytical laboratory.
  • Columnist for Pharmaceutical Quality & Formulation Magazine and Food Quality Magazine.

Speaking Engagements

  • American Chemical Society National Tour Speaker
  • Faculty Member, The Parental Drug Association (PDA)
  • American Laboratory Management Association

Education

B.S. in Chemistry, Wagner College

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