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

Technical Consultant #1166

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.

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.

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

Speaking Engagements

B.S. in Chemistry, Wagner College