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Expert in Pharmaceutical Development, Analytical Methods, Method Validation and GMP/Part 11 Compliance
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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Expert has been involved with cGMPs since their re-release in March 1979. For 7 years during his tenure at Roche he was Compliance and Training Officer for the Technical Development and Kilo Lab Departments, and developed schemes by which the Pilot Plant could reasonably and efficiently comply with those regulations. At Ohmeda PPD, being the sole administrator for the Pharmaceutical Research Facility for the first 6 years of his tenure, he operated the GMPs for Phases 0 to Phase 3 of the Drug Development Process. He is adept at the correspondence of GMP with ICH and the Risk Based Directives introduced in 2003. He organized and reviewed SOPs, provided expert advice and remediation for the operation and training in cGMP systems for clients. He provided clients with protocols and/or critical reviews of Method and Process Validation Systems in the laboratory, plants and for training. He wrote protocols for and advised on Technology Transfer, Part 11 and laboratory organization. He provided CMC Reviews to clients for FDA submission. He Developed and administered yearly course in cGMPs and Validation for a National Professional Meeting (Eastern Analytical Symposium)(-1989-2002) and Part 11 (2003). He prepared clients for external auditing and structure. He provided evaluation and removal of deficiencies from internal and external inspections. He determined organizational needs and management systems for compliant GMP, ICH operations. He performed GMP and generalized QA for Production and Development operations. He directed the activities for formulation/pre-formulation research while at Ohmeda, PPD. He directed the efforts leading to the establishment of metabolism pharmacokinetics of drugs in body fluids. He directed the efforts leading to a full understanding of degradation in dosage forms, as well as the pathway of the degradation of liquid (gaseous) anesthetics by soda lime in anesthetic delivery systems (subject of White Paper to FDA, CDC, 1993). He delegated full activities leading to the successful submission of the Chemistry, Manufacturing and Controls Section of many INDs and NDAs for new drug candidates. He directed an FDA PAI.
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: New York, New York;
Yonkers, New York;
Newark, New Jersey;
Jersey City, New Jersey;
Paterson, New Jersey;
Elizabeth, New Jersey;
Bridgeport, Connecticut;
New Haven, Connecticut;
Hartford, Connecticut;
and Philadelphia, Pennsylvania.
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Degree |
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Subject |
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Institution |
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1954
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B.S.
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Pharmacy
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University of Pittsburgh
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1956
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M.S.
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Pharmacy
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University of Pittsburgh
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1961
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Ph.D.
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Medicinal Chemistry
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University of Pittsburgh
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Employer |
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Department |
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Title |
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Responsibilities |
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1995 to
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(Undisclosed)
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Pharmaceutical Consulting
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Owner/Operator
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1985 to 1995
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OHMEDA PPD (formerly Anaquest) (bought out by Baxter Healthcare))
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Pharmaceutical and Analytical Research
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Senior Scientist start-- Director at end
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1979 to 1985
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Hoffmann La-Roche Inc.
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Technical Development Department
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Senior Technical Fellow
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• He was responsible for the upgrading of HPLC usage for the department
• He was responsible for the acquisition and implementation of a CLAS/LIMS minicomputer network and XL-200 NMR and Analect FT/IR Systems.
• He was responsible for tracking the success and budgetary compliance of Divison-Wide Projects.
• He was GMP Trainer and Compliance Officer for Tech Dev. Dept. PilotPlant and Kilo Lab.
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1978 to 1979
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Hoffmann La-Roche Inc
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Analytical Development/Technical Division
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Manager
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• He was responsible for directing the Analytical section with an acceptable turnaround time and % of budget.
• He was responsible for the development of the organizational parameters for a company-wide chemical safety testing laboratory.
• He was responsible for Implementing a useful program for the use of DSC for vapor pressure studies and for purity analyses.
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1974 to 1978
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Hoffmann La-Roche Inc
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Chemical Development Section of TDD
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Asst. Manager
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He was responsible for combining the GLC/LC section with the Analytical Development Wet Chemistry Control section to supply the Chemical Engineering Development and Biotechnology Process Development department with chromatography support.
• He introduced GC/MS for solution to TDD problems
• He increased management scope to include analytical service to all operating sections of TDD which required enlarging the group from 10 to 17 chemists and technicians.
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1972 to 1974
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Hoffmann La-Roche Inc.
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Chemical Development Department/TDD
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Senior Chemist
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He reorganized an existing analytical function of 4 from a QC type operation for the Chemical Development Section to an R&D analytical function for 3 operating sections of TDD.
• He successlilly reorganized the analytical facility into an R&D lab providing basic analytical service to 3 operating sections of TDD.
• He increased management scope from 4 to 10 chemists and technicians to accommodate the increased work load.
• He introduced the use of analytical proton and fluorine NMR for process problems.
• He introduced DSC and purity by DSC for process problems.
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1971 to 1972
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U.S. Bureau of Customs Laboratory System
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Research Branch, NY and Washington Lab.
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Chief ,Research Branch of NY Laboratory System.
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He organized a newly formed research group to upgrade obsolete methods to those using (state-of-the-art )instrumentation.
• He provided GLC and GC/MS assistance to the Washington, DC research lab.
• He developed 3 quantitative NMR methods for imported chemicals.
• He improved the research efficiency by 30%.
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1967 to 1971
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Hoffmann La-Roche Inc
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Analytical Research Department/QC Division
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Manager Analytical Research I
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He was responsible for Line management of an instrumentation, drug stability and dosage form analysis group of 34 professionals.
• He directed a special projects group of 3 for structure determination of degradation products and impurities.
• He introduced the use of NMR as an analytical Q.C. tool.
• He introduced 3 (quantitative) fluorine-NMR methods for drug products.
• He planned, acquired and implemented the use of a PACE EAI Minicopmputer lab data system for automation of 16 gas chromatographs (first in the company).
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Associations/Societies
APhA, A.C.S., International Society for Magnetic Resonance (ISMAR), NY Acad Sci., PDA, Eastern Analytical Symposium Inc., Assoc. Chem. Consultants and Chemical Engineers (A.C.C. & C.E.), Soc Sigma Xi.
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Licenses/Certifications
R.Ph. NY and PA
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Professional Appointments
EAS Board President (1993);
Editorial Advisory Board, Applied Spectroscopy
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Awards/Recognition
Distinguished Alumnus PittSchool Pharmacy 1992;
Cedar Grove, NJ. J.B.L. Man of the Year 1984
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| Publications: |
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Publications and Patents Summary
He has 32 Publications, a recurring book chapter on Natural Products (5 cycles), 5 Invited Papers, 28 Presentations.
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| Government Experience: |
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Description |
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1971 to 1972
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U.S. Bureau Customs Laboratory
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Organize NY Research Faciity
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He was responsible for organizing a fledgling Research Branch and Heading up its activities for modernizing Research Analytics.
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| Selected Consulting Examples: |
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He assisted a team of Validation and Protocol experts determine compliance with standard GMP regulations.
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He was a member of a team of compliance experts reviewing company position for re-certification of products after consent-decree.
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He reviewed Validation and Technology Transfer methods and results prior to a Pre-Approval Inspection Visit.
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He visited, reviewed and advised on the transfer of activities from Univ Research Facility to MiniPilot Activity.Helped to plan Class 100 facility.
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He evaluated Plant Annual reports and OOS and OOG Summaries for effective PCCE reporting on company certification and Quality efficiency.
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Expert Witness Experience Summary:
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1. He was expert advisor to Roche Patent Attorneys in Patent Interference proceedings for MediPhysics vs. P&G relating use of Tc 99m for Diagnostic Testing. 2. He was deposed as an Expert Witness in wrongful death proceeding for Ohmeda PPD vs Georg (Cincinatti, OH). Case settled. 3. He assisted BOC Group general counsel in formulating approach to wrongful death actions on misuse of vials of Brevibloc.
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Recent Litigation Client Requests:
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Expert for consulting on in pharmaceutical manufacturing for litigation.
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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
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Expert is free.
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| International Experience: |
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Summary |
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1991 to 1991
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UK/Southport
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He reviewed lab operation, installed instrumentation and transferred analytical technology for anal. research and QC use.
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1993 to 1993
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Limoge, France
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He successfully transferred analytical technology to outsourcing laboratory
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1993 to 1993
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South Wales
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He performed a GMP audit of manufacturing lab and was "man in plant" for transferring dosage form preparation in satellite facility.
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He worked closely with Plant Engineers and Chemists in scale-up of newly approved anesthetics in a unique packaging.
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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.
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Expert is free.
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| Additional Skills and Services: |
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Training/Seminars
1. He developed and delivered training course for Pharmaceutical Training Institute Int'l in Validation of Computerized laboratory Instruments. One Year.
2. He developed and delivered cGMP Short Course at Eastern Analytical Symposium Yearly Meetings for 13 years.
3. He developed and delivered an Introduction to 21 CFR Part 11 for EAS Short Courses; one year.
4. He developed and delivered Short Course on Practical GC for Pharmaceutical Scientists for EAS; one year.
5. He developed a session for the 6th Annual Technology Transfer Conference (LaJolla, CA 2003) on "cGMP Compliance for a Successful Technology Transfer".
6.He developed and carried out a Workshop on Validation of Pharmaceuitcal Laboratories and Facilities.
7. He developed and delivered a Workshop at EAS in Compliance Predictions during RE-Validation.
8. He developed and delivered symposia on the Utility of Analytical Chemistry in the Development of Pharmaceutical Product Research and Development.
9. He formulated a symposium on the approach of risk-based-factors for the new GMP.
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Supplier and Vendor Location and Selection 1. He was the primary moving force in the acquisition of 2 LIMS based CDSs, and one minicomputer based CDS before LIMS was established.
2. He was the point man for acquisition of High Resolution NMR Instrumentation and GC/LC and MS systems, as well as FTIRs.
3. He was the deciding voice in the procurement of outsourcing for excess Validation and Stability of upcoming Pharmaceutical Products.
4. He chose a route and Vendor for the outsourcing of Blood Level and Bio-Pharmaceutical Studies on new Products.
5. He was the lead investigator in use of labs in UK and in France for Preparation of Dosage Forms for use in UK, development of level sensor in Anesthetic Vaporizers manufactured in UK, and for Analytical Release of Anesthetics in UK and France.
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Other Skills and Services
He established a mechanism for the off-ended production of CO in Chlorofluoro ether anesthetics and instructed marketers and sales in explaining its path and avenues for minimization.
He wrote a white paper on the issue for dissemination to FDA Medical Device Group and to CDC&P.
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Education
