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 Expert  107595

Expert in Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs


Available for your Consulting and Expert Witness Needs

Illinois (IL)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices.

As a professional consultant to the healthcare manufacturing industries, he works with about 30 worldwide companies annually in the areas of quality assurance auditing, US current Good Manufacturing Practice regulation implementation, 21CFR11 electronic record regulation assessment and GMP/Quality Technology training.

He has also helped these companies prepare for and pass U.S. FDA inspections and inspections of the European and Australian regulatory agencies - first time through. Expert's clients tend to fall into two groups: those that desire to pass an FDA inspection, for whom Expert plans the strategy to be followed to assure success first time through; and those who have failed an FDA inspection, received a Warning Letter and/or Temporary Restraining Order (TRO) and need to strategize the fastest possible means of satisfying FDA in order to get back into business and revert to positive cash flow. To date, Expert has achieved a 100% success level with both types of clients - when they have listened to him, and followed his advice.

His consulting assignments divide approximately 50% in the pharmaceutical manufacturing sphere, 25% in bulk pharmaceutical chemical (API) manufacturing, and 25% in medical device manufacturing.

Additionally, Expert provides training courses in-house in the fields of Good Manufacturing Practices, Validation, Quality Assurance Auditing, Good Documentation Practices, 21CFR11-Electronic Record Compliance, Technical Aspects of Pharmaceutical Water Systems, Managing the Quality Control Laboratory, and R&D technology transfer.

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pharmaceutical manufacturer

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pharmaceutical manufacturing

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bulk pharmaceutical chemical manufacturing

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bulk drug

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medical device manufacturing

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Current Good Manufacturing Practice

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drug processing

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drug validation

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Food and Drug Administration compliance

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Good Manufacturing Practice

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pharmaceutical quality assurance

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European Union's Good Manufacturing Practice

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Food and Drug Administration validation

Expert is extremely knowledgeable in the fields of pharmaceutical manufacturing plant layout and design, sterile product manufacture, aseptic and medical product packaging, small volume parenterals, and dosage form design. He is very knowledgeable in the medical device industry particularly regarding sterile and invasive devices.

He has designed seven pharmaceutical factories in four countries. He has also critiqued the designs of over twenty other company's facility designs for compliance with Good Manufacturing Practice (GMP) regulations.

Expert is experienced in conducting company audits to ensure that clients' medical device and pharmaceutical products and processes meet the standards required by the FDA and foreign governments for manufacture and quality. Expert can provide guidance on European drug and medical device regulations. He can also assist with bulk chemical, drug, and medical device, and nutritional product registrations in the U.S., Canada, Australia, and the European Community.

Expert has worked in FDA regulated pharmaceutical and medical device industries his entire working career. At various times, he has been responsible for GMP and GLP compliance. He has defended companies during FDA inspections, has prepared companies for FDA inspections, and has masterminded and prepared over 150 companies to pass FDA GMP inspections. He has managed regulatory affairs departments and has been responsible for pharmaceutical ANDA submissions, bulk pharmaceutical DMF submissions, and medical device 510(k) submissions. Additionally, he has trained FDA inspectors and has provided litigation support to FDA.

Expert is fully familiar with FDA regulations impacting the pharmaceutical and medical device industries. He has often provided companies with consulting advice on FDA regulation interpretation, and is often called upon by attorneys to assist clients in trouble with FDA to manage a "corrective action plan." Expert has worked under FDA consent decrees and is fully familiar with the strictures imposed. During his career Expert has provided GMP training to government inspectors in China, where he trained the first biological product GMP inspection force; India, where he trained the first All-India medical device inspection force; and at the FDA. The faculty at the University of Illinois have a contract to train FDA inspectors. Additionally, under United Nations assignments he has performed training in Cuba and Vietnam.

Expert has managed pharmaceutical manufacturing operations in Israel and the United Kingdom. In addition, he has audited pharmaceutical, active pharmaceutical ingredient, biotechnology, and medical device companies in 37 countries. As a consultant, Expert has worked on five continents for periods ranging from a few weeks to several months. For five years Expert was the Assistant Plant Manager in a U.S. company that manufactures intravenous solutions in flexible PVC bags. He also has experience in the manufacture of IV fluids in glass bottles and in blow-fill technology.

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facility design

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medical product packaging process

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aseptic packaging process

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aseptic filling

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quality engineering

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plant layout

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manufacturing facility design

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medical device manufacturing quality control

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pharmaceutical manufacturing facility auditing

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Food and Drug Administration

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Food and Drug Administration regulation

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inspector training

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international manufacturing

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intravenous drug delivery

In addition to five years managing a facility manufacturing large volume parenterals (LVPs), Expert has also had three years experience as the production manager of a U.S. factory manufacturing small volume parenteral (SVP) products in ampule, vial, and syringe delivery formats.

Expert was also the chairman of the PDA Task Force that developed and published the definitive industry guideline "PDA Monograph -- Validation of Aseptic Processes for Liquid Drug Products," in 1980.

Expert's career has included 15 years working within the pharmaceutical industry worldwide and 15 years working as a consultant to the pharmaceutical industry worldwide. He counts over 200 clients in his consulting portfolio. Expert has managed a quality control laboratory for two years, and as a pharmaceutical industry consultant, he is constantly auditing QC laboratories for compliance with GMP requirements. He is frequently asked questions regarding optimal laboratory layout and "laboratory work efficiency."

Expert regards himself as a "professional quality assurance auditor." When working in the pharmaceutical industry, he had direct QA responsibilities on the plant and corporate levels for many years. Since becoming a consultant, he has spent 15 years evaluating QA systems in all types of companies worldwide. Expert is also a recognized third-party GMP inspector by the Australian and Malaysian governments. His inspection reports are sent directly to these authorities for their decision as to whether a company Expert has inspected meets their GMP standards. Expert lectures on quality assurance matters at the postgraduate level publicly.

Expert has performed quality audits for 20 years. He does internal audits within companies and external audits of potential raw material and bulk chemical suppliers and potential contract manufacturers (both clinical trial manufacturers and commercial scale manufacturers). He has written a book on Quality Auditing techniques, "Auditing By Mail."

Expert performs a minimum of 12 vendor, supplier, contractor audits annually and has done so for over 10 years, primarily focusing on GMP compliance status. Expert has audited over 200 companies in 37 countries. He has the ability to perform rapid incisive audits that provide clients with the information they need to know to assess regulatory, business and economic risks associated with the use of a particular vendor or contractor.

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parenteral product

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parenteral product manufacturing

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parenteral product packaging

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sterilization processing technology

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sterile product aseptic manufacture

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terminal sterilization

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pharmaceutical industry

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pharmaceutical quality control

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quality assurance

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quality auditing

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vendor quality auditing

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manufacturing quality assurance


Show Only Primary Areas of Expert Consulting

Secondary Expertise
air quality standard, aseptic pharmaceutical process validation, bio-clean room, biomedical device manufacturing, bottle filler, bottle rinser, bottle washer, bulk mixing, bulk packaging material, capsule packaging process, clean room, clean room design, compliance testing, consumer product packaging, contract manufacturing, Current Good Manufacturing Practice auditing, deionized water, design-for-quality, drug container, drug dosage form development, drug labeling requirement, drug regulation, drug stability, European drug registration, excipient, FDA medical device regulation, Food and Drug Administration drug registration, generic drug, generic drug manufacturing, governmental registration process, health care quality assurance, industrial plant design, industrial sterilization, injectable drug, ISO 9000 series quality system standard, laboratory design, laboratory quality assurance, medical device, medical device auditing, medical device inspection, medical device manufacture clean room, medical device process validation, medical device sterilization, medical informatics, medical product manufacturing, medical software quality assurance, pharmaceutical analysis, pharmaceutical aseptic filling room, pharmaceutical capsule, pharmaceutical drug, pharmaceutical engineering, pharmaceutical intermediate, pharmaceutical packaging process, pharmaceutical research and development, pharmaceutical technology, pharmaceutical water treatment system validation, quality control, quality evaluation, quality standard, sterile packaging process, tablet manufacturing, tablet packaging process, tableting, time dating, validation, water quality standard

Basic Expertise
American Society for Quality Control, automated filling, automated filling machine, CE Marking, chemical manufacturing technology, chemical processing plant design, class 10 clean-room management, clean-in-place, data processing facility design, dosage form, drug, drug analysis, EN 29000 quality standard, European labeling requirement, European standard, European statute, filling process, first article inspection, Food and Drug Administration new drug code, foreign medical device regulation, gelatin capsule, grinding operation facility design, international organization, international standard, Japanese marketing, labeling process, over-the-counter cosmetic, over-the-counter drug, over-the-counter drug packaging, package regulation, package testing, packaging material, pharmaceutical chemistry, pharmaceutics, project management, standard, wet granulation
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Chicago, Illinois;  Rockford, Illinois;  Aurora, Illinois;  Naperville, Illinois;  Joliet, Illinois;  Elgin, Illinois;  South Bend, Indiana;  Gary, Indiana;  Milwaukee, Wisconsin;  and Madison, Wisconsin.

Often requested
with this expert:

Pharmaceutical Product Development and Good Manufacturing...
Pharmaceutical Manufacturing
Regulatory Compliance Auditing, Training; FDA NDA/ ANDA and...
GMPs for Drugs, Devices, Biologics

Education:
Year   Degree   Subject   Institution   Honors
1981   M.B.A.   Management   Lake Forest College, Illinois   With Distinction
1980   M.S.M.   Management   Lake Forest College, Illinois  
1971   M.S.   Pharmaceutical Technology   London University, England   Magna cum Laude
1969   B.Pharm.   Pharmacy   London University, England   Honors
1972   Diploma in Middle Eastern Studies   Middle Eastern Studies   The WUJS Institute - Arad, Israel  

Work History:
Years   Employer   Department   Title   Responsibilities

1986 to

 

(Undisclosed University)

 

Pharmaceutics

 

Lecturer in Pharmaceutical Technology

 

He lectures to undergraduates and post-graduates in pharmaceutical and quality technology. He focuses on pharmaceutical technology, quality assurance and GMP for the maufacture and testing of sterile and non-sterile pharmaceuticals, diagnostics and medical devices.

1985 to

 

(Undisclosed Consulting Company)

 


 

Senior Consultant

 

He provides consulting services in the fields of pharmaceutical technology, quality systems, Good Manufacturing Practices (GMPs) and Validation for governments and industry clients worldwide. He also specializes in guiding clients through first time approval by regulatory GMP inspection agencies (FDA, MHRA, HPFBI, TGA) of operations, and advising clients on rapid recovery from adverse regulatory inspections.

1981 to 1985

 

American Hospital Supply Corporation

 

American Critical Care

 

Director of Research

 

He worked on technology transfer support to divisions worldwide. He also was an internal corporate consultant on pharmaceutical manufacturing and quality assurance matters.

1976 to 1981

 

American Hospital Supply Corporation

 

American Critical Care

 

Director, Quality Assurance

 

He worked to assure compliance of all company sites and contract manufacturing sites worldwide to Corporate Quality Standards and FDA Good Manufacturing Practice Regulations.

1972 to 1976

 

Baxter/Travenol

 

Israel

 

Assistant Plant Manager

 

He directed manufacturing operations at a facility that manufactured pharmaceuticals and medical devices. He was resposible for logistic operations for the Middle East and sub-Saharan Africa. he was also resposible for day-to-day plant operation in the manufacture of sterile pharmaceuticals/medical devices for domestic and export sale.


Career Accomplishments:
Associations/Societies

Expert is a member of the Parenteral Drug Association and former chairman of the PDA task force that developed guidelines for the manufacture of drug products by aseptic filling. He is also a member of the American Association of Pharmaceutical Sciences, the Regulatory Affairs Professionals Society, the International Society of Pharmaceutical Engineers, and several international associations that deal with health related manufacturing and product registration.

Licenses/Certifications

He is a Licensed Pharmacist in the United Kingdom and Israel. He is a Qualified Person in the European Union.

Professional Appointments

Expert has been a member, past or present, of the following editorial boards: Drug GMP Report, Industrial Pharmacist, GMP Review, Pharmaceutical and Cosmetic Quality, Journal of Parenteral Science and Technology, and the Medical Device and Diagnostic Industry Conference Advisory Board.

Awards/Recognition

Expert is listed in "Who's Who in the World -- 2001". He is also in the GMP Institute Hall of Fame.


Publications:
Publications and Patents Summary

Expert is the author and editor of seven books in the field of pharmaceutical product quality and Good Manufacturing Practices. He is also a columnist for "Pharmaceutical and Cosmetic Quality" magazine.

Selected Publications and Publishers  
 - Interpharm Press  

Consulting Services:
Selected Consulting Examples:
  • Expert conducted a gap analysis of client readiness to pass an FDA Pre-Approval Inspection.
  • He has provided expert witness testimony in litigation between companies, and between government agencies and companies.
  • He prepared Validation Master Plans (VMPs) for pharmaceutical and biotechnology companies.
  • Expert did a facility design critique for compliance with Good Manufacturing Practice requirements.
  • He has designed Quality Assurance Systems for pharmaceutical and medical device manufacturers.
Recent Client Requests:
  • GMP expert in bulk chemical manufacturing for consulting on the development of a new cGMP Bulk manufacturing facility.
  • CMC expert for consulting on FDA regulatory strategy for transfer of manufacturing site from the USA to Germany.
  • FDA expert to provide training regarding GMP and nw regulations.
  • OTC expert for consulting on new product launch.
  • FDA expert for consulting on FDA Product registration.
  • Expert in IV fluids design for consulting on Manufacturing facility of lab ware products.
  • Expert in GMP certification for consulting on the manufacturing of small scale ca. 2-5 kg of product.
  • GMP expert needed for consulting on 21 CFR Part 111 dietary supplement GMPs.
  • Expert in pharmaceutical excipient for consulting on the GMP and other regulatory requirements for stability testing.
  • FDA expert for consultation to provide pre approval and post approval support to ensure approval of a NADA with a minimum of time spent in the review cycle of T-Pro.
  • Expert in surface contamination found on/in syringe components.
  • Expert for consulting on PuraCap Pharmaceutical - S. Plainfield, NJ.
  • Expert for consulting on GMP manufacturing certification for a software company.
  • Usp validation expert.
  • Pharmaceutical manufacturing expert for consulting on software development.
  • EU cosmetic expert for consulting on advising CTO to meet 76/768/EEC requirements.
  • Expert in FDA compliance for consulting on manufacturing packaging for OTC customer.
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:
Expert has provided expert witness services in civil litigation and criminal litigation (FDA vs. pharmaceutical companies). He has been deposed many times.
Recent Litigation Client Requests:
  • Expert for consulting on transdermal patch litigation ase.
  • Phamaceutical Technology expert for consulting on glass vial delamination.
  • Expert for consulting on in pharmaceutical manufacturing for litigation.
  • API Sterilization expert expert for consulting on Generic Pharma Patent Litigation.
  • Pharmaceutical manufacturing expert to evaluate manufacturing process and CGMP issues related to a pharmaceutical company's production of a double dosage of certain drugs.
  • Expert in MHRA to provide opinion on MHRA audit in litigation case.
  • Expert in current good manufacturing practice for consulting on GMP.
  • Expert in deviations in manufacturing pharmacutical resulting in alleged contamination.
  • Medical device expert for consulting on quality of syringes.
  • Clean room expert for consulting on Drug contamination case.
  • Contract manufacturing expert witness pharmaceuticals for consulting on Trial on pharmaceutical contract manufacturing.
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
Europe, Japan and Australia   Expert has extensive international experience, having worked outside the U.S. for 10 years. He typically works in 10-15 counties each year. He has handled the registration of drugs and devices in Europe, Japan, and Australia.
Europe   He has spent much time in European facilities advising on American standards and regulatory requirements, including expiration dating and other labeling issues.
Australia and Malaysia   Expert performs GMP audits on behalf of the Australian and Malaysian governments.

Language Skills:
Foreign Language   Description
Hebrew   Having lived in Israel for seven years, Expert is proficient in Hebrew. He has lectured to companies and university students in Hebrew.
French   Expert has managed a company department where all the workers were French-speaking North Africans.

Market Research:
Expert was the founder and owner of a publishing company and a seminar company that reached sales of $5M (USD) prior to his sale of the company. He was entirely responsible for all aspects of marketing.

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

Expert lectures worldwide to professional organizations, and publicly on international GMPs, validation, quality assurance, 21CFR11 (electronic records) and FDA matters. Courses he offers publicly and on-site include "Fundamentals and Essentials of Good Manufacturing Practices," "Fundamentals and Essentials of Validation," "Preparing For and Passing an FDA Inspection," and "Effective Quality Assurance Auditing," and "Good Documentation Practices."

Supplier and Vendor Location and Selection

Expert frequently performs audits of potential raw material suppliers and contract manufacturing facilities (for clinical trial manufacture, and commercial scale manufacture).

Other Skills and Services

Expert has trained FDA inspectors as well as government inspectors in India and China. He works extensively in the healthcare manufacturing field for United Nations agencies worldwide.


 

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