Expert Details

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

Expert ID: 107595 Illinois, USA

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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.

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.

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 a definitive industry guideline textbook.

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.

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.

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.

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 - Madison, Wisconsin

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Education

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

Work History

Years Employer Title Department Responsibilities
Years: 1986 to Present Employer: Undisclosed Title: Department: Pharmaceutics Responsibilities: 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.
Years: 1985 to Present Employer: Undisclosed Title: Senior Consultant Department: Responsibilities: 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.
Years: 1981 to 1985 Employer: Title: Director of Research Department: Responsibilities: He worked on technology transfer support to divisions worldwide. He also was an internal corporate consultant on pharmaceutical manufacturing and quality assurance matters.
Years: 1976 to 1981 Employer: Title: Director, Quality Assurance Department: Responsibilities: He worked to assure compliance of all company sites and contract manufacturing sites worldwide to Corporate Quality Standards and FDA Good Manufacturing Practice Regulations.
Years: 1972 to 1976 Employer: Title: Assistant Plant Manager Department: Responsibilities: 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.

International Experience

Years Country / Region Summary
Years: 2000 to Present Country / Region: Europe, Japan and Australia Summary: 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.
Years: 2000 to Present Country / Region: Europe Summary: He has spent much time in European facilities advising on American standards and regulatory requirements, including expiration dating and other labeling issues.
Years: 2000 to Present Country / Region: Australia and Malaysia Summary: Performs GMP audits on behalf of the Australian and Malaysian governments.

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". He is also in the GMP Institute Hall of Fame.
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 a pharmaceutical magazine.

Additional Experience

Expert Witness Experience
Expert has provided expert witness services in civil litigation and criminal litigation (FDA vs. pharmaceutical companies). He has been deposed many times.
Training / Seminars
Expert lectures worldwide to professional organizations, and publicly on international GMPs, validation, quality assurance, 21CFR11 (electronic records) and FDA matters. He offers courses that include best practices of pharmaceutical technology and quality systems and regulations.
Vendor Selection
Expert frequently performs audits of potential raw material suppliers and contract manufacturing facilities (for clinical trial manufacture, and commercial scale manufacture).
Marketing Experience
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.
Other Relevant Experience
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.

Language Skills

Language Proficiency
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.

Fields of Expertise

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

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