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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.