Expert Details
FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
ID: 724181
Michigan, USA
-Buildings, facilities, equipment, laboratories, and processes;
-Standard Operating Procedures;
-Training;
-Documentation;
-Personnel observation.
Expert uses a checklist as a guide. The checklist also serves as reference to a notebook into which detailed entries are made during the audit. While the checklist is to guide the auditor, is not intended to be a substitute for knowledge of the GMP regulations and general manufacturing experience.
Expert was the Site Manager of a 120 person, high tech pharmaceutical manufacturing site at BASF. He was in charge of Quality, Production, Engineering and Maintenance for Active Pharmaceutical Ingredient synthesis, Spray Drying Plant, Liquid Food Blends, Human Nutrition Premix, shipping & receiving, hiring & firing; 120 people; $200M/yr in sales. He was also 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 he 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
Expert has lead the development of cross-functional and high performance teams in many organizations. He transformed a compartmentalized management structure at a pharmaceutical plant into a team driven system with fewer layers of management.
The trick in any team building project is to unite a group of people with different skills, experience, and personalities around a common goal and make the whole greater than the sum of the parts. The leader must insure that the conflict that arises when a diverse, motivated team works closely together is controlled and creative rather than destructive.
Expert is a Senior Partner at Employer, a GMP compliance consulting firm. He manages compliance, training, validation, and new product development projects. He writes and executes validation protocols. He provides guidance to customers on cGMP compliance in a wide range of industries, including pharmaceuticals, tissues, medical devices, dietary supplements, and excipients. He has developed many training classes and delivered them to a diverse audience in FDA regulated industries. He has received recognition for excellent work and generated repeat business.
Expert has led multinational project teams to develop new pharmaceutical excipients. He insured that all members of the teams contributed despite the fact that they came from multiple countries and multiple companies.
As plant manager of an API plant he led the investment in over $10M of capital per year, all of which was on time and on budget. Among these projects was an advanced technology distillation column, the most advanced production distillation column in the world at the time. In addition he installed a new Distributed Control System, which allowed the identification of Key Process Parameters. Using SPC he 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. He used Design of Experiment techniques to reduce product overages and save $300k/y. Expanded plant capacity by 30% while simultaneously reducing emissions. Used SPC to reduce variability in Spray Drying Plant and saved $200k/y.
Pharmaceutical validation experience. He has written and executed a wide variety of protocols for customers in the pharmaceutical and medical device industries. He has managed large validation projects. The key to his success is the merging of general managerial experience with knowledge of the regulations. This allows the customer to be given a compliance system that is both consistent with the regulations but also is flexible enough to be used in the real, competitive world of business today.He has managed new product development projects for Fortune 100 companies. He lead a multinational project team to commercialize a new pharmaceutical product.He has given numerous training seminars to companies that are trying to find cost effective ways to comply with FDA regulations. These seminars are customized to the needs of the workers at the customer location so that the content is relevant to them and therefore increases the chances of them actually using the training when they get back on the job.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1973 | Degree: PhD | Subject: Organic Chemistry | Institution: UCLA |
| Year: 1969 | Degree: BS | Subject: Chemistry | Institution: UC Berkeley |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2004 to Present | Employer: Undisclosed | Title: Senior Partner | Department: |
Responsibilities:He manages projects, sets marketing goals, estimate bids, and sells to customers. He hires subcontractors and employees. Writes and executes validation protocols, conducts audits, consults with customers on responses to FDA questions, and writes Drug Master Files. |
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| Years | Employer | Title | Department |
| Years: 1975 to 2004 | Employer: BASF | Title: Plant Manager | Department: Fine Chemicals |
Responsibilities:He was the 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. |
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| Years | Employer | Title | Department |
| Years: 1973 to 1975 | Employer: University of Chicago | Title: Research Fellow | Department: Chemistry |
Responsibilities:Research on synthetic enzymes |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 1988 to 1990 | Country / Region: Germany | Summary: He lead a subteam of an international team that developed a new product for BASF. His subteam actually invented the new product. They proved that it worked in the lab and scaled it up to commercial production. The product was then made and sold throughout the world. |
| Years: 2003 to 2005 | Country / Region: Germany | Summary: He lead a project team that developed a new pharmaceutical product. The project involved multiple parallel pathways that had to be merged together at the end to insure successful commercial introduction of the product. These pathways included process development, capital investments, toll production, marketing, sales, and regulatory activities. |
Career Accomplishments
| Associations / Societies |
|---|
| American Chemical Society International Society for Pharmaceutical Engineers |
| Publications and Patents Summary |
|---|
| He has eight publications on various technical and management subjects. He is authoring a book. |
Additional Experience
| Expert Witness Experience |
|---|
| He has served as an expert witness. He has been deposed in Federal Court. The case involved the efficacy of a constituent and its duty classification. Another case involved multiple illnesses associated with manufacturing errors of a dietary supplement. |
| Training / Seminars |
|---|
| He developed or participated in developing over 50 training seminars involving FDA compliance and managerial excellence. He has facilitated many of these seminars with a wide variety of customers and university audiences. He developed and delivered video training for the University of Michigan Medical Innovation Center. He is an adjunct faculty at the University of Michigan, Ann Arbor. |
| Vendor Selection |
|---|
| He selects subcontractors for his company. He also works with his clients to select processing equipment including stability chambers, reactors, tanks, packaging equipment, pumps, vacuum systems, valves, piping, analytical equipment, PLC's, and tanks. |
| Marketing Experience |
|---|
| He has lead or participated in teams which have commercialized over a dozen products. Most have been in the pharmaceutical or Fine Chemicals area. He makes sales calls for his company. |
| Other Relevant Experience |
|---|
| He has led multinational project teams. He insured that all members of the teams contributed despite the fact that they came from multiple countries and multiple companies. He has conducted hundreds of training seminars through his consulting company. He has saved millions of dollars for companies through SPC, outsourcing, capital projects, and smart regulatory compliance. |
Fields of Expertise
auditing, bulk drug, active pharmaceutical ingredient, bulk pharmaceutical chemical manufacturing, drug formulation, drug formulation, cross-functional team, self-directed work team, team building, Current Good Manufacturing Practice, drug validation, Food and Drug Administration compliance, Food and Drug Administration cosmetic regulation, FDA medical device regulation, Food and Drug Administration regulation, Food and Drug Administration validation, Good Manufacturing Practice, nonaseptic pharmaceutical process validation, quality, aseptic pharmaceutical process validation, project management, hiring, cultural transformation, abbreviated new drug application, business process management, business development, business operations, Food and Drug Administration National Drug Code, generic drug manufacturing, business management, bulk mixing, generic drug, six sigma quality, pharmaceutical capsule, tablet manufacturing, chemical plant management, design-for-quality, chemical management, excipient, drug stability, drug development, drug analysis, business re-engineering, defect, Food and Drug Administration, chemical processing, drug regulation, drug, Food and Drug Administration new drug code, Good Laboratory Practice, drug screening