Expert Consulting and Expert Witness Services

Expert in Litigation - Expert Witness on Pharmaceutical Matters (FDA Compliance)

Expert 723111

Expert in Litigation - Expert Witness on Pharmaceutical Matters (FDA Compliance)

Available for your Consulting and Expert Witness Needs

Career Accomplishments

Consulting Services

Expert Witness

Market Research


Summary of Expertise:

Primary Expertise Areas: (links show more experts in each area)	Expertise Description:
bulk mixing expert bulk packaging material expert consumer product packaging expert Current Good Manufacturing Practice expert drug labeling requirement expert drug regulation expert FDA food labeling regulation expert Federal Food, Drug, and Cosmetic Act expert Food and Drug Administration expert Food and Drug Administration CFR-21 part 175 expert Food and Drug Administration compliance expert Food and Drug Administration cosmetic regulation expert Food and Drug Administration drug packaging regulation expert Food and Drug Administration drug registration expert Food and Drug Administration food packaging regulation expert Food and Drug Administration medical device regulation expert Food and Drug Administration National Drug Code expert Food and Drug Administration new drug code expert Food and Drug Administration regulation expert Food and Drug Administration validation expert food inspection expert food regulation expert Good Manufacturing Practice expert governmental registration process expert Nutrition Labeling and Education Act of 1990 expert over-the-counter cosmetic expert over-the-counter drug expert over-the-counter drug packaging expert over-the-counter drug regulation expert pharmaceutical packaging process expert prescription drug expert tablet packaging process expert bulk drug expert expert witness active pharmaceutical ingredient expert aseptic pharmaceutical process validation expert batch mixing expert bulk liquid expert bulk material expert bulk materials handling expert bulk pharmaceutical chemical manufacturing expert capsule packaging process expert clean-in-place expert coating material expert compliance testing expert consumer product expert contract manufacturing expert cosmetic exported product expert cosmetic industry expert cosmetic product expert cosmetic raw material specification expert delayed-action drug expert drug label comprehension research expert drug product approval expert food additive regulation expert Food and Drug Administration food regulation expert food facility expert food industry quality assurance expert food industry quality control expert food processing good manufacturing practice expert Generally Recognized As Safe expert generic drug expert generic drug manufacturing expert Good Manufacturing Practice training expert pharmaceutical capsule expert Safe Medical Devices Act of 1990 expert tablet manufacturing expert	Expert is a Doctor of Pharmacy Compliance Consultant in FDA matters. He has been a consultant to hospitals, pharmacies, and pharmaceutical manufacturers. He has performed over 500 Pharmaceutical Manufacturing Audits for FDA Compliance. He has performed In Depth Audits for Hospital Affiliates, (Absorbed by HCA) pharmacy departments, provided advice on utilization of personnel, stock controls, pharmacist liability, etc. Expert has set up repackaging centers for most retail drug chains, CVS, Giant, Revco, Eckerds, Walgreens, WalMart, Neighbor Care, Stop & Shop, Rite Aid, Brooks, LaVerdieres, Longs, Thrifty, Thrift and many others. He has participated in 10 FDA Injunction cases for the government and for private clients. Expert has testified several times before State and Federal Congressional committees. He has also worked on several liability cases in defense of pharmacists or pharmacies. He has assisted attorneys in 3 separate liability cases involving fire damage to pharmaceutical operations. Expert has organized, Directed and Participated in over 50 training seminars for the pharmaceutical, retail drug chains, dietary supplement industry and state boards of pharmacy. Expert has experience with manufacturers and distributors of dietary supplements and has provided expert advice to many such companies.
21 CFR Part 11 expert	He has been retained by several companies to assist them in preparing their bulk manufacturing processes for compliance with CGMP so that the active pharmaceutical ingredient may be used in filing NDAs The manufacturing sites and processes must abide by the CGMP and with my help they have been successful.
Show Secondary and Basic Areas of Expertise
*Localities:* Expert may consult nationally and internationally, and is also local to the following cities: Tampa, Florida; Saint Petersburg, Florida; Orlando, Florida; Clearwater, Florida; Lakeland, Florida; Largo, Florida; and Sarasota, Florida.

Education:

Year		Degree		Subject		Institution
1950		Doctor of Pharmacy		Pharmacy		Univ of Tenn College of Pharmacy

Work History:

Years	Employer	Department	Title	Responsibilities
1974 to	(Undisclosed)		President	Doctor of Pharmacy Compliance Consultant in FDA matters. Consultant to hospitals, pharmacies, and pharmaceutical manufacturers, food and dietary supplement manufacturers, device manufacturers and food warehouses
1958 to	(Undisclosed)	Pharmacy Director	CAPTAIN Pharmacy Director	Inactive Reserves. Served many short tours of Active Duty as Medical Coordinator and or Pharmacy Director for US Agencies including FDA

Career Accomplishments:

Associations/Societies

Pharmacy Director, US Public Health Service Reserves; Outstanding Unit Citation, US Public Health Service; Certificate of Appreciation from Surgeon General; President, SW Florida Chapter Association of Military Surgeons of the USA; Master Mason, Cumberland Lodge, Nashville TN; Owned and Operated, Expert's Prescription Lab (The first Pharmaceutical Repackager in US; Organized and Directed The Association of Drug Repackagers Inc.; Provided Consulting services to over 750 Pharmaceutical & Dietary Supplement Manufacturers and Distributors; Provided Consulting services to the majority of the major Retail drug chains in US in regards to their prescription services.

Licenses/Certifications

Doctor of Pharmacy, State of Tennessee

Professional Appointments

Board of Directors Pure Bioscience Inc.; Former member of Surgeon Generals Speakers Bureau

Awards/Recognition

Certificates of Appreciation from US Surgeon General PHS; President of SW Florida Chapter of Association of Military Surgeons of USA

Publications and Patents

Many articles and talks presented at various Association meets, Participated on panels for FDLI and presented talks to various organizations such as The Kentucky Feed Mills Ass, The National Association of Chain Drug Stores and others

Government Experience:

Years	Agency	Role	Description
1951 to 1954	US Army	Hospital Pharmacist
1954 to 2006	US Public Health Service Reserves	Pharmacy Director	Pharmacist and Medical Coordinator at Camp Krome Immigrations Center in Miami Florida

Consulting Services:

Performed In Depth Audits for Hospital Affiliates, (Absorbed by HCA) pharmacy departments, provided advice on utilization of personnel, stock controls, pharmacist liability, etc.

Directed and participated in 10 training seminars on the PDMA for wholesalers and distributors

Set up repackaging centers for most retail drug chains, CVS, Giant, Revco, Eckerds, Walgreens, Wal-Mart, Neighbor Care, Stop & Shop, Rite Aid, Brooks, LaVerdieres, Longs, Thrifty, Thrift and many others.

Prepared the CGMP for dietary supplements for the NNFA. Provided advice and counsel to over 30 dietary supplement manufacturers and distributors. Performed 100s of label and literature reviews for dietary supplement products as well as OTC drug products. Inspected over 500 manufacturing plants for compliance with FDA rules and regulations including dietary supplements, devices, drugs, & cosmetics

Served as Expert witness in many legal cases, both product liability, malpractice, patent problems etc.

Served as expert witness for FDA as well as Industry

As a member of the Intota consultant network, Expert is a specialist who provides technical consulting to corporate, legal and government clients. Expert provides professional consulting as a Litigation - Expert Witness on Pharmaceutical Matters (FDA Compliance) Consultant. Expert may consult as an independent consultant or as a member of a consultancy, consulting company, or consulting firm. Consultants service will be covered by a consulting contract. Ask an expert initial screening questions and ask the experts services particulars, by simply submitting an expert request.

Expert Witness:

10 FDA Injunction cases for the government and for private clients. Participated in several liability cases in defense of pharmacists or pharmacies. Assisted attorneys in 3 separate liability cases involving fire damage to pharmaceutical operations. Served as Expert for 4 malpractice cases, (Pharmacy malpractice, Medical Mal Practice) and 4 product liability cases)

Intota experts can serve as expert witnesses or litigation consultants offering expert testimony, expert advice, litigation support, forensic services, and related expert witness services. Expert can serve as an expert witness or litigation consultant in intellectual property (patent, trademark, trade secret, copyright), product liability, and insurance matters. Expert may provide forensic expert witness testimony, litigation consulting services, forensic investigation, and forensic testing if appropriate in litigation areas as a Litigation - Expert Witness on Pharmaceutical Matters (FDA Compliance) Expert Witness. Intota provides attorneys and legal professionals the opportunity to ask an expert initial screening questions and ask the experts services particulars by submitting an expert request.

International Experience:

Years	Country / Region	Summary
1974 to	Israel	Consultation with TEVA prior to their becoming international company. 2 day consultation in Israel
2003 to 2004	Puerto Rico	Retained to organize and set up a Repackaging center for client in Ponce, Puerto Rico

Market Research:

Expert serves as a resource to Intota Market Research Services for customized marketing research in industries or areas related to Litigation - Expert Witness on Pharmaceutical Matters (FDA Compliance). Experts are an invaluable source of overall industry insight as well as insight into specific companies and firms for custom business to business (b2b) and industrial market research. Intota uses analyst and consultant resources from Guideline whose Research Directors manage the research and analysis of the qualitative and quantitative data as well as report writing for the custom studies. The methods and tools used by Intota market research combine the insights of technical experts and industry insiders with secondary research to provide the custom b2b and industrial market research you need.

Additional Skills and Services:

Training/Seminars

For the past 20 years, Expert has organized and runs a non profit educational organization. He provides CGMP training to personnel in the food, drug, device, cosmetic and dietary supplement industries. Expert has held over 40 such seminars in cooperation with FDA and several state agencies.

Supplier and Vendor Location and Selection

He has worked with his clients in purchasing many types of manufacturing equipment. Including trips to Germany to inspect their manufacture and use. Also in validating the performance for the clients purposes.

Need the right expert? We can help!