FDA Regulations Manufacturing Technology Expert Witness

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FDA Regulations Manufacturing Technology Expert Witness

Provides Opinion & Testimony In:

Regulatory Affairs, FDA Regulations, Quality Systems, Drug Formulation, Quality Management, Dietary Supplement, Medical Device, User Requirements Specification, Design Development Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, Pharmaceutical, Validation, Compliance, CAPA, Corrective Preventive Action, Root Cause Analysis, Risk Assessment, Failure Mode Effects Analysis, Fault Tree Analysis, HAZOP, Hazard Analysis Critical Control Points, R&D, New Product Development, Calibration, Installation Qualification, Operation Qualification, Performance Qualification, Process Validation, Process Design, Process Performance Qualification, Continuous Process Verification, Statistical Process Control, Stability, Change Control

Professional Experience

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

Managed compliance, training, validation, and new product development projects.  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.  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.  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.  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- 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.


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

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


Available upon request