Pharmaceutical Laboratory, QA/QC, Validation and Stability (1166)
Expertise
Extensive experience in the pharmaceutical, nutraceutical and chemical industries including:
Laboratory Management and Problem Solving
Validation
Stability
QC/QA
Training
Document Writing
FDA Problem Resolution
Experience
2003 - Present Consulting
Project work includes cleaning validation, design and execution, including method development and validation and complete overhaul of laboratory systems for a prescription drug manufacturer for regulatory compliance.
1996 - 2003 Lycoming Analytical Laboratories, Duboistown, PA, President and Laboratory Director
In support of pharmaceutical clients, directed all technical activities including analytical design, technical review, supervision of staff, document preparation and review, regulatory compliance, security and customer interaction. Sold company to Chemir Pharma Services.
1992 - 1996 independent Consultant
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, training, management planning and technology upgrades. As a managing consultant, brought the chemistry/lab into substantial compliance for firm under FDA consent decree. Subsequent inspection by FDA yielded no 483 observations under chemistry.
1990 - 1992 Barr Laboratories, Pomona, New York, Director of Analytical Laboratories
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. Greatly increased departmental office efficiency through the use of advanced computer technology for the management of scientific information.
1988 %u2011 1990 Consultant
Focused on Quality Control and Quality Assurance in pharma plant,in areas of product testing, complaint handling, customer audits and data analysis for over300 different products. Designed reduced sampling%u2011testing protocol that resulted in 1500 man%u2011hour overtime reduction. Implemented technology upgrade in Q.C. lab with 800 man%u2011hours per year impact in labor savings.
1986 %u2011 1988 Private Formulations, Inc., Edison, New Jersey , Director of Quality
Responsible for direction of all quality control, quality assurance, analytical methods development and regulatory affairs for solid%u2011dosage, OTC drug products. Launched a 10%u2011month lab improvement program that resulted in FDA inspections going from unsatisfactory to satisfactory.
Honors & Publications
Textbooks entitled "Managing the Analytical Laboratory; Plain and Simple", 1996, and "The Q.C. Laboratory Chemist; Plain and Simple",1998, both from Interpharm Press, Inc., Buffalo Grove, IL.
Columnist for Pharmaceutical Quality & Formulation Magazine and Food Quality Magazine.
Education
B.S. in Chemistry, Wagner College