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 Expert  107842

Expert in FDA Compliance, Pharmaceutical New Products, Management Training, Seminars, Inspections, Audits


Available for your Consulting and Expert Witness Needs

Georgia (GA)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
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.

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.

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).

Expert has instructed Strategic Planning at DuPont Merck and for Immaculata College. Several years before, he prepared the strategic plan for The West Company.

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.

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.

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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Food and Drug Administration compliance

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Food and Drug Administration drug packaging regulation

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Food and Drug Administration drug registration

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drug container

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product-package system compatibility evaluating

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product-package system development

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Current Good Manufacturing Practice

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corporate strategic planning

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laboratory management

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parenteral product manufacturing

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regulatory compliance auditing

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.

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".

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.

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. 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.

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.

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.

The LAL test is for endotoxins. The test as used by any laboratory must be used properly and by trained persons.

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.

Have managed analytical chemistry laboratories in industry and for the Federal Government, specifically for the Food and Drug Administration.

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.

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.

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.

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.

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.

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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research and development productivity

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bulk pharmaceutical chemical manufacturing

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business management

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contract manufacturing

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drug stability

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drug screening

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FDA food labeling regulation

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FDA limulus amebocyte lysate test regulation

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Food and Drug Administration validation

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analytical laboratory

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drug product approval

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generic drug manufacturing

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Good Laboratory Practice

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Good Manufacturing Practice

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Good Manufacturing Practice training

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investigational drug

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.

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.

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.

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.

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.

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".

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.

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.

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 container ingredient leaches into the drug. Such interactions are not acceptable and will ruin a product.

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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laboratory process development

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management decision-making

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new drug

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parenteral product

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pharmaceutical industry

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pharmaceutical manufacturing facility auditing

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pharmaceutical packaging process

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product approval

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product-package system

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total quality control

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total quality management

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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work-flow layout


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.

Often requested
with this expert:

Pharmaceutical Process Validation & FDA Compliance
Pharmaceutical Technology, Manufacturing, Quality Systems...
FDA Regulations, GMP/ GLP/ GCP Compliance; IND, NDA, BLA,...
Food Packaging, Food Safety, Food Quality, Food Additives;...

Education:
Year   Degree   Subject   Institution  
1974   MBA   Marketing and Finance   Temple University  
1961   MS   Physical Chemistry   St. Joseph's College  
1957   BA   Chemistry   LaSalle College  

Work History:
Years   Employer   Title  

1996 to

 

(Undisclosed Consulting Company)

 

Principal,

 

1992 to 1996

 

Science Branch, Philadelphia District FDA

 

Director,

 

1989 to 1992

 

Philadelphia FDA

 

Special Projects,

 

1982 to 1989

 


 

Jay and Associates and Expert Seminars

 

1966 to 1982

 

The West Company

 

Assistant Director of Laboratories,

 

1964 to 1966

 

Wyeth Laboratories

 

Senior Research Chemist,

 

1961 to 1964

 

SKF Industries

 

Research Chemist,

 

1957 to 1961

 

Smith Kline & French Laboratories

 

Research Chemist,

 

Career Accomplishments:
Associations/Societies

Expert is a member of the American Chemical Society (ACS) and the Parenteral Drug Association (PDA).


Publications:
Publications and Patents Summary

In addition to being the author of technical publications, Expert holds two patents (sole owner) related to an environmentally-friendly, timed-release, agricultural/horticultural chemical delivery system based on an elastomeric formulation.


Government Experience:
Years   Agency   Role   Description
1989 to 1996   FDA   Director Science Branch   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.

Consulting Services:
Selected Consulting Examples:
  • Legal Experience Expert has completed working on a legal case where Pharmaceutical Firm A contracted with Pharmaceutical Firm B to run a process on their product and then return it to Pharmaceutical Firm A. When the procedure was complete and the material returned, Firm A claimed that the material had been changed and was no longer what it should have been. Firm A is seeking an amount of over $5 million from Firm B. The insurance company and the attorneys representing FirmB have retained Expert to review all the necessary data and information throughout the history of theproduct from Firm A to Firm B and back again in order to determine just what happened, where ithappened, and when it happened.
  • Expert audited a pharmaceutical raw material supplier firm.His evaluation, and recommendation of it, led his client to contract with that firm to produce the active ingredient for their product.
  • Expert audited a pharmaceutical contract manufacturer.His evaluation, and recommendation of it, led his client to contract with that firm to produce their product for them, thus saving the client a capital expenditure for plant expansion.
  • Expert prepared and presented a seminar on Good Manufacturing Practices for a client. This was included as part of new employee training and of recurrent training for existing employees.
  • Expert reviewed existing, and composed new, methods and procedures for both manufacturng and the Laboratory for a firm. This assisted and enabled them to pass an FDA inspection.
Recent Client Requests:
  • FDA expert to provide training regarding GMP and nw regulations.
  • Expert in cGMP assistance.
  • Expert in Regulatory/compliance requirements on drug packaging requirements.
  • FDA expert forconsulting on FDA audit inspection.
  • Expert in FDA GMP training and SOPs for staff to manufacture/assemble medical devices.
  • GLP expert for consulting on a facility evaluation for GLP conduction and IND and beyond.
  • Expert in FDA compliance for consulting on FDA compliant pharmaceutical document management.
  • FDA expert for consulting on ANDA submission.
  • Expert in FDA compliance to provide training seminar on CGMP's.
  • FDA labeling expert for dietary suplements for consulting on verifying claims with the FDA.
  • Expert in customs regulations dealing with country of origin.
  • Expert in CMC FDA.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
Reviews and evaluates depositions and other information in Pharmaceutical company cases. Various types of cases to include patent infringement litigation.
Recent Litigation Client Requests:
  • Expert witness pharmaceutical industry for consulting on Pharmaceutical industry reporting obligations to insurance carrier.
  • FDA regulations and/or scientific research standards expert for consulting on litigation against pharmaceutical company from wrongful termination of employee.
  • Expert for consulting on FDA compliance for OTC drugs.
  • FDA expert witness generic drug for consulting on Litigation in Federal Court.
  • FDA regulations expert for consulting federal criminal case and trial testimony.
  • FDA expert witness for consulting on an atypical antipsychotic..
  • Expert in current good manufacturing practice for consulting on GMP.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Country / Region   Summary
Germany   Conducted an investigation into a product failure to determine what caused the product to fail. This was done while in the U S via e-mail, telephone, fax and Express delivery of charts and documents. Did not travel to Germany.
France   Constructed a Drug Master File (DMF) for a French pharmaceutical processing company. This document was needed by the U S FDA. This was done while in the U S via e-mail, telephone, fax and Express delivery of charts and documents. Did not travel to France.

Language Skills:
Foreign Language   Description
Spanish   can read a bit of Spanish.

Market Research:
Assists pharmaceutical firms in FDA regulatory submissions thereby facilitating the marketing of new products

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Develops and presents seminars on FDA regulations and on management subjects to many clients including some Fortune 500 organizations.

Supplier and Vendor Location and Selection

Evaluates pharmaceutical suppliers of raw materials and of packaging services. Conducts inspections and audits.

Other Skills and Services

Assists pharmaceutical companies in workflow and management structure, and in complying with FDA regulations


 

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