Pharmaceutical Auditor: cGMP Auditing, AMP Compliance, CMC Preparation, Veterinary Drugs, Product Formulation, Software Validation

Expertise

• Expert in: cGMP audits and compliance evaluations, CMC document preparation,

product formulation and design, chemical supplies management, contractor management, package development, software validation, and veterinary drugs.

• Rebuilding businesses, restructuring organization and moving into new manufacturing facility.
• Built quality systems, rewrote SOPs, designed and implemented new batch record system, directed validation group, and developed and implemented training program.
• Formulate, test and commercialize oral care products based on nutritional and homeopathic active ingredients. Direct efforts to patent product concepts.
• Prepare CMC section of IND and verify compliance of clinical supplies with cGMP.
• Validate analytical methods. Develop stability protocols and implement stability programs.
• Prepare SOPs for conversion of laboratories from ISO 9000 to cGMP compliance. Audit cGMP compliance of contract manufacturing facility.
• Audit facilities for cGMP compliance. Coordinate program to upgrade facilities and procedures to bring operations into compliance with cGMPs.

Oversee preparation of clinical trial materials for U.S. studies.

Experience

Undisclosed Company, President, 1990 - Present

• Establish and operate consulting firm specializing in quality assurance and control; cGMP audits, compliance and training; regulatory compliance and document preparation, product formulation/design, clinical supplies management, contractor management, and package/ process development.

Projects

Gentium SpA

• Write CMC section for biological drug product for fast track drug product for submission to FDA and EU.
• Guide development and implementation of Quality System and cGMP compliant documentation and manufacturing practices to meet U.S. standards.
• Coordinate clinical supply labeling, packaging and distribution in the U.S.A. and for Canada.

Palatin Technologies

• Implement, direct and monitor contract manufacturing of new commercial drug product.
• Develop component specifications, identify suppliers and manage on-going manufacturing operations.
• Write SOPs for manufacturing department. Write, review and edit CMC related documentation.

Vyteris Corporation

• Review analytical method validation studies and prepare study reports.
• Guide GMP compliance and prepare Quality Control laboratory SOPs and documentation for Pre-Approval Inspection.

Sharp Corporation Inc., Interim Vice President Quality Assurance

• Direct quality assurance and validation departments for major contract pharmaceutical packager.
• Respond to FDA Warning Letter and remediate quality system to comply with cGMPs. Developed and implemented cleaning validation program.

Almedica Services Corp., Inc.

• Direct and manage Quality Assurance department for clinical trial materials packager.
• Develop quality system, revamp SOPs and implement a GMP training program. Train on cGMP compliance. Direct validation of new facility including classified clean rooms.
• Develop and implement Cleaning Validation Program. Member of executive committee.

C. S. Bioscience, Inc.

• Formulate, test, scale-up and implement manufacture of oral care products based on nutritional and homeopathic active ingredients.
• Identify suppliers and contract manufacturer and direct manufacturing operations.

Kaz Inc.

• Prepare Quality Manual, SOPs and compliance documentation for medical device manufacturer.
• Provide Regulatory Affairs guidance on device registration, compliance and labeling. Train Quality Department personnel on cGMPs and on the Quality System and its implementation.

The West Company

• Prepare SOPs for conversion of laboratories from ISO 9000 to cGMP compliance. Train lead trainers on cGMPs for laboratories.

Zambon Corporation

• Provide all phases of clinical supplies development, production, documentation and cGMP compliance.
• Audit internal and contract manufacturing and laboratory facilities for cGMP compliance. Review CMC sections of INDs and NDAs.
• Train U.S. and foreign employees on cGMP compliance.

American Home Products, Inc, (Boyle-Midway Household Products, Inc), 1987 - 1990

Vice President

• Identified and evaluated technology providing strategic opportunities for new business areas and new products.
• Established and coordinated product development program in cooperation with Fortune 10 chemical manufacturer.
• Negotiated exclusive license for novel product providing entry into $5BB market previously untapped by company.
• Provided technical leadership for facility and process audit and upgrade. Directed multi-plant quality control department.

Vice President Research and Development, 1987 - 1989

• Directed research and development package engineering multi-center quality control and Regulatory Affairs Departments.
• Initiated and managed acquisition of license for novel compound from Fortune 10 AgVet Company.
• Within one year developed and tested new product competing in $50 million market. Coordinated cGMP and GLP compliance during development and field trials.
• Developed and introduced new products and new packages.
• Directed team developing and engineering new packages and labeling systems.
• Directed and audited quality assurance and control groups and compliance with SOP's.
• Validated contract manufacturers and material suppliers.

The Hartz Mountain Corporation, Harrison, NJ, 1972 - 1987

Divisional Vice President - Food and Chemical Product Development, 1984 - 1987

• Directed development and commercialization of new products.
• Created Right-to-Know programs and managed Hazardous Waste Disposal.
• Authored and coordinated compliance with SOPs for the production of OTC Veterinary drug product such as wormer capsules, antibiotic seed and vitamin tablets; pet foods; liquid, powder and aerosol chemical specialties.
• Developed and tested new packages and validated manufacturing processes for FDA regulated products.
• Directed and designed clinical trials of remedies and fortified foods. Established product stability, wrote protocols, identified cooperators and designed and prepared clinical supplies. Introduced compliance programs for cGMPs and GLPs.

Director, Chemical Sciences, 1981 - 1984

• Directed product development, analytical and pilot plant departments.
• Managed development of new pet foods; OTC veterinary products; and liquid, powder and aerosol chemical products. Prepared clinical trial materials.
• Coordinated process introduction to manufacturing, including equipment evaluation, facility engineering and process validation.
• Wrote and enforced procedures for production and quality assurance.

Manager, Chemical Sciences, 1972 - 1981

• Directed product development - laboratory formulation, process development, liquid and aerosol package development, stability testing, toxicology, clinical evaluation, manufacturing initiation and quality assurance. Research Group Leader, Plant Manager, 1972 - 1973
• Designed, built and operated PVC extrusion plant producing EPA-regulated controlled release product.

Honors & Publications

Academic and Professional Affiliations

• American Chemical Society
• Licensing Executive Society
• Society of Plastics Industry
• Controlled Release Society
• Society of Packaging Professionals
• Berkeley Heights Board of Education
• Berkeley Heights Planning Board

Publications and Patents

• Author of over 30 national and international short courses in: Preparation, Labeling of Clinical Supplies.
• Author of over 20 technical presentations.
• Author and Co-Author of over 50 publications; monthly column in the Pharmaceutical Formulation and Quality, magazines and books.

Education

• Ph.D. Chemistry, University of Wisconsin, Milwaukee, WI
• M.S Chemistry, University of Wisconsin, Milwaukee, WI
• B.S. Chemistry, Illinois Institute of Technology, IL