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Summary of Expertise:
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During his employment with the Food and Drug Administration, Expert received five grade promotions, with his last position being that of Director of the Science Branch of the Philadelphia District. Expert's area of responsibility included all the pharmaceutical firms in Pennsylvania, Delaware, and New Jersey, an area that includes 75% of the innovators and several generic firms. During that time, while his primary assignment was to direct the activities of the laboratory chemists with regard to the direct laboratory work and with regard to the chemists participating on inspections with the investigators, Expert was asked to direct the Investigations Branch for a two month period of time. His previous work history shows that he was employed in various technical management functions for pharmaceutical firms and for pharmaceutical packaging firms. Expert has been on both sides of the regulatory hurdle and, as such, is in a good position to counsel others on how to surmount that hurdle. Expert started Expert's Firm two years ago so that he could help firms bring their products from
discovery to the marketplace in the shortest possible period of time.
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Expert has 25 years experience in the pharmaceutical and pharmaceutical packaging industries. His 16 years at The West Company provided Expert with much knowledge about containers and container systems as used in the pharmaceutical industry. The primary components were rubber, plastic, glass, and aluminum. Package-product compatibility is an area of expertise that he developed at that time and has used in his current consulting.
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Expert's experience in industry and especially that at the Food and Drug Administration provides him with the knowledge of Good Manufacturing Practices. The GLPs are part of the GMPs, and Expert have a special expertise in that, having directed an FDA laboratory. Another area of Expert's expertise is that of laboratory support of the manufacturing process, where samples are taken during production and
delivered to the laboratory for analysis to determine if the series of steps in the production process
are on track and therefore should continue. He is very familiar with the GMPs as contained in Parts
210 and 211 of Title 21 of the Code of Federal Regulations (21 CFR).
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Expert has instructed Strategic Planning at DuPont Merck and for Immaculata College. Several years before, he prepared the strategic plan for The West Company.
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Expert has acquired laboratory management skills over the years from his work experience in the pharmaceutical industry, in the pharmaceutical packaging industry, and with the Food and Drug Administration.
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Expert's experience at The West Company and with the FDA and in his two years as Expert's Firm has provided him with experience in this area. The West Company's primary products are materials used in parenteral
product manufacturing. Expert was a member of the Parenteral Drug Association (PDA) while at The
West Company, and he is now a member on his own as Expert's Firm. He has
been published in the Journal of the Parenteral Drug Association. Additionally, some of his
assignments as Expert's Firm have involved parenteral products and, in fact,
lyophilized products. Expert has helped one company work its way out of a Consent Decree, which
involved a problem with a freeze dried (lyophilized) product. He helped another company bring a
new, freeze dried product to the market, a product that is anticipated at having $100 million sales the
first year.
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Regulatory Compliance auditing is a large part of
what Expert does now at Expert's Firm. He has helped establish and reviews quality
assurance plans.
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Expert has extensive experience in general
work flow analysis and productivity improvement in a research and development lab. He
understands how to avoid unnecessary redundancies and knows when to stop a particular aspect of
a project and go on to another.
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This can be the pharmaceutical product, the excipients, or the Active Pharmaceutical Ingredient, API. In any case the procedure must meet FDA regulations with complete validation of the process and of the test methods used to evaluate the "product".
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Night School - Adjunct Instructor. Philadelphia, PA.
After teaching Physical Chemistry at Saint Joseph's University for 20 semesters, taught Business Management at a Penn State University area campus for several semesters. The Penn State students all had at least a bachelor's degree and some years working experience.
Used the book that Expert wrote. Has own Consulting business.
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Today, many pharmaceutical companies "contract out" some or all of their manufacturing and packaging. These contractors must meet the same regulatory standards as the contracting Pharmaceutical company.
They are audited to ensure that this is so.
Expert conducts such audits.
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A drug preparation must be proven to be stable at least up to the expiration date on the label. Stability studies are done on new drugs to determine the stability characteristics. Samples are stored at different time and temperature and humidity stations. They are removed and analyzed at pre-determined times, and a "Stability Profile" is thus produced.
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Drugs are tested to ensure that they are as pure as claimed, initially, and after storage.
The test procedures must be validated to ensure that they are providing the correct results.
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New Labeling regulations were produced and issued 10 years ago. This set of regulations provides the consumer with knowledge about aspects of food products with which to make intelligent purchase decisions.
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The LAL test is for endotoxins.
The test as used by any laboratory must be used properly and by trained persons.
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Validation is a term used for pharmaceutical processes and test procedures as used by the firms and their contractors. The FDA does not validate; the company does.
The FDA reviews the company validation
reports to be sure they did it correctly.
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Have managed analytical chemistry laboratories in industry and for the Federal Government, specifically for the Food and Drug Administration.
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Primary business is assisting clients in Drug Product Approval.
For over ten years have been assisting pharmaceutical companies from concept through R & D to product manufacturing, in obtaining FDA approval.
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Have inspected generic drug firms for the FDA and as a consultant. Generic firms must meet the same FDA requirements and standards as the innovator firms.
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GLPs are included under GMPs. These are the requirements/standards set by the FDA.
Have inspected firms for GLP/GMP compliance when with the FDA and later, as a consultant.
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Have inspected drug firms and contractors for GMP compliance when with the FDA and as a consultant.
GMPs are the requirements/standards set by the FDA to ensure the proper quality of product.
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All personnel in a drug firm must be trained in GMPs. Annual training is required.It must be documented for all employees.
More detailed and specific training is required depending on the employee's individual assignments.
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An investigational drug is one that is being administered to people through an Investigational New Drug Application (IND). An IND gives authorization to conduct clinical trials of a new drug. If the results are good then a request to market the drug is made. This is an NDA or New Drug Application.
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Have directed analytical chemistry laboratories in the pharmaceutical industry and for the FDA.
Now, consult on laboratory analyses and procedures. Also consult on how to manage a laboratory.
Laboratory support of process development includes testing samples from parts of a process to determine if that process is doing what it is designed to do.
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Have directed analytical chemistry laboratories in the pharmaceutical industry and for the FDA.
Now, consult on laboratory analyses and procedures. Also consult on how to manage a laboratory. Have lectured on management decision making and taught management principles at evening school at a Penn State University Philadelphia Pennsylvania area campus for several semesters.
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A new drug is any new chemical entity that fits the FDA definition of "drug", that is not on the market. Potential new drugs must go through animal studies, and then clinical trials before information is submitted for FDA approval to market the new drug.
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Parenteral actually means any route other than through the alimentary canal. However, it is most commonly used in describing injectables. Production of an injectable product is very involved since sterility must be maintained.
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This includes the innovators and the generic firms that produce drugs. It also includes the firms that contract to manufacture, package, and test pharmaceutical products. All are subject to FDA regulations. Career has been in the pharmaceutical industry, with the FDA and for the last 10 years as a pharmaceutical consultant.
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An audit is conducted to ensure that all systems are functioning as designed and are in compliance with FDA regulations. At times an audit will reveal a deficiency.
If such a deficiency exists it should be corrected.
There are auditors, however there must also be "fixers".
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This is the set of steps involved in placing the pharmaceutical product into its final package.
For example, if tablets, they are counted, placed into the appropriate contained, the container sealed and the proper label affixed.
Usually this is done automatically. The system must be monitored to ensure that it is functioning properly.
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Quality Assurance is the system that assures that the product is manufactured and tested properly to ensure the "purported quality" of the product. Quality Control is a part of this system. It is concerned with the monitoring and testing of raw materials, work-in-process and finished product. Product approval within a company is usually given by the Quality Assurance department.
Product approval is a term that also refers to the FDA approval of a new drug.
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This refers to the final packaged form of the drug.
Testing should have been done to ensure that there was and will be no package-product interaction.
Such interaction could be that the container reacts with the drug substance, or the drug is adsorbed onto the walls of the container, or the a container ingredient leaches into the drug. Such interactions are not acceptable and will ruin a product.
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This refers to the quality control of the raw materials, work-in-process, and the finished product.
This is accomplished by testing the materials and procedures used to manufacture the product.
Results are compared to previously established standard values.
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This refers to the quality control of the raw materials, work-in-process, and the finished product.
This is accomplished by testing the materials and procedures used to manufacture the product.
Results are compared to previously established standard values. This also includes the management of the work flow involved in the Quality Control and Quality Assurance functions.
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The manufacture of a new drug involves raw materials, work-in-process, and the finished product.
Quality Control is maintained by testing the materials and procedures used to manufacture the product.
Results are compared to previously established standard values. The management of the work flow as depicted in a work flow diagram ensures that the product is made and tested in a sequence that will contribute both to the quality of the product and the efficiency of work.
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Show Secondary and Basic Areas of Expertise |
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Savannah, Georgia;
Charleston, South Carolina;
and North Charleston, South Carolina.
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Education
