FDA Regulations Manufacturing Technology Expert Witness

Professional Experience

2002 – Present, Sr. Partner, Validation & Compliance Institute.

Managed compliance, training, validation, and new product development projects. Led multinational project teams. FSMA, 510k clearances, PMAs, NDAs, ANDAs. Wrote and executed validation protocols. Provided guidance to customers on cGMP compliance in a wide range of industries, including pharmaceuticals, medical devices, biotech, tissues, dietary supplements, and excipients. 21 CFR 111, 117, 211, 820. Developed many training classes and delivered them to a diverse audience in FDA regulated industries. Received recognition for excellent work and generated repeat business. Performed audits. Established supply chains and conducted risk assessments and quality audits. Mitigated quality problems by troubleshooting suppliers or switching suppliers as necessary. Consulted with Medical Innovation Center at U. of Michigan, assisting researchers with compliant commercialization of new medical devices. Quality Systems: Design Control, Change Control, Management Review, CAPA, Nonconformance Investigations, FDA response letters, Audits, Drug Master Files. Managed Quality System upgrade projects for major medical device companies. Remediation: Consent Decree, Warning Letters. Managed compliance, training. Developed methods for helping organizations to convert training knowledge into behavior change in the workplace. Led multinational project teams. Adjunct Professor of Regulatory Sciences at University of Michigan, Ann Arbor. Chemistry Advisory Board, Lawrence Technological University.

• Performed audits
• Pharma
• Medical devices
• Dietary supplements
• Validation:
• Validation Master Plans
• CSV
• Led the design and validation of medical device embedded software according to IEC 62304
• ERP validation
• Distributed Control System validation
• Requirements Specifications, Design Control, Process Development Summaries, Tech Transfer Documents, Process Characterization, Risk Management

Equipment qualification, Utilities qualification, USP water systems, Aseptic filling; Blenders: ribbon, Vee, conical, tanks, in-line; Centrifuges; Clean rooms; CNC cutting; Crystallizers; Cold Chambers; Distillation towers: atmospheric to high vacuum; Distributed Control Systems, SCADA; Emulsifiers: inline, disperser blades, impingement; Encapsulators, Extraction; Fluid bed driers; Filters; Granulators; Heat exchangers: plate & frame, shell & tube; Lyophilizers; Manual assembly; HPLCs; Metal detectors; Ovens; Packaging equipment; Particle sizers; Programmable Logic Controllers; Plastic molding; Pumps: centrifugal, positive displacement; Reactors; Screens; Solvent strippers; Spectrometers; Spray chillers; Spray driers; Stability chambers; Steam sterilizers; Tableting machines; Tanks; Vacuum pumps: liquid ring, oil diffusion, piston, steam ejectors.

• Process Performance Qualification, Mixing validation, Cleaning Validation
• Continuing Process Verification, SPC
• Analytical Method Validation,
• Rule 26 reports; critiqued opposing witness depositions
• Depositions; deposed by Federal Attorney
• Testimony in Federal Court
• ISO: 13485, 14971, 9001, 17025

Expert witness; wrote witness statement; critiqued opposing witness statements; deposed by Federal Attorney.  Authored articles for professional journals.

1997-2002, Site Manager of a 120-person, high tech pharmaceutical manufacturing site, BASF.

In charge of Quality, Production, Engineering and Maintenance for Vitamin E synthesis, Spray Drying Plant, Liquid Food Blends, Human Nutrition Premix, shipping & receiving, hiring & firing; 120 people; $200M/yr. in sales. Responsible for tolling operations in multiple locations. Saved the business $5M in capital by tolling out new products rather than manufacturing in-house. Budget responsibility for $23M in fixed cost. Dotted line responsibility for other service groups. Converted business information management system to SAP.  Constructed new technology distillation column, the first example of brand new technology to be built outside of corporate headquarters. Installed a new Distributed Control System, which allowed the identification of Key Process Parameters. Using SPC we established allowable ranges for the Key Process Parameters. By keeping the parameters within those ranges product quality was improved, end of pipe testing was reduced, downtime was minimized, and equipment reliability was improved. Overall savings were $1.8M/yr.

1994 – 1996, Plant Manager, Vitamins Plant, BASF.

Managed production of Vitamin E, Spray Drying Plant, Liquid Food Blends, shipping & receiving, hiring &
firing; 80 people.  Upgraded cGMP compliance program to comply with new FDA regulations. Validated
API processes in the plant.  Used Design of Experiment techniques to reduce product overages and
save $300k/y. Expanded Vitamin E Plant capacity by 30% while simultaneously reducing emissions.
Used SPC to reduce variability in Spray Drying Plant and saved $200k/y.

1984 – 1994, Production Manager, Vitamins Plant, BASF.

Managed production of Vitamin E, Spray Drying Plant, Liquid Food Blends, New Product Development,
and shipping & receiving; 45 people. Lead the development and patenting of many new formulations.
Developed new method of purifying Vitamin E, which reduced waste and reduced costs by $100k/y. This
new technology plus others that were developed in the Wyandotte Vitamins Plant were installed in other
BASF vitamin plants around the world.  Wrote Drug Master Files. Lead the justification process for new
Liquid Food Blends Facility.  Started up new Spray Drying facility.

1977 – 1984, Production Superintendent, Vitamin E Plant, BASF.

Managed production of Vitamin E. Expanded capacity of plant by 100% with less than $1M total capital;
20 people. Was selected as ombudsman for production and maintenance employees which provided an
incentive for them decertify their union.

1976 – 1977, Startup Engineer, Polyol Plant, Washington, NJ, BASF.

Helped to start up 5 kgal polyether polymerization reactors.  Lead the startup of new prilling tower.
Wrote SOP’s.

1976- Pilot Plant Engineer, Wyandotte, MI, BASF.

Managed production of herbicide production facility. Set monthly production records. Developed new purification process which stopped corrosion of glass lined reactor.

1975 – R&D Chemist, Wyandotte, MI, BASF.

Developed method for producing record high molecular weight polyether polyols.

1973 – 1975.  Postdoc, University of Chicago.

Education

Ph. D., Organic Chemistry, University of California, Los Angeles.  1973

BS., Chemistry, University of California, Berkeley.  1968.

Publications

Available upon request

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