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Pharmaceutical Development Risk Management FDA Review Expert Witness

Provides Opinion & Testimony In:

Pharmaceutical Development, Pharmaceutical Scale Up, Instrumentation, Manufacturing, Drug Development, Drug Safety, FDA Medical Device Regulation, 21 CFR Part 11, FDA New Drug Review Approval Procedures, Standard Operating Procedures, FDA Regulation Compliance, Product Process Optimization, Science, Statistics, Pharmaceuticals Regulatory Affairs, Quality Assurance, GXP, GMP, GLP, GCP Compliance, Regulatory Issues, Risk Management, Review FDA Correspondence,

Expert No. 3278

TECHNICAL SKILLS AND QUALIFICATIONS

•    Expert in pharmaceutical process optimization and scale-up with many years of experience and worldwide name recognition.
•    Working knowledge of Process Analytical Technology (PAT), FDA and EU regulatory compliance, Solid Dosage (granulation and compression) unit operations and scale-up, 21 CFR Part 11 compliance, Equipment and Process Validation, Quality Assurance, FAT/SAT protocols, IQ/OQ/PQ documentation, Six Sigma process, risk management. cGMP, GAMP, SUPAC.
•    Experienced in all aspects of project management and documentation for instrumented solid dosage equipment.
•    Professional knowledge of instrumentation, data acquisition systems and control for solid dosage equipment.
•    Skilled in theoretical and technical aspects of compaction and tableting, wet granulation, and roller compaction for pharmaceutical R&D, process and product optimization, process scale-up.
•    Many years of business management and operations, including accounting, education, training, product marketing and sales.
•    Qualified computer programmer, including expert command of VB6, VB.net and VBA, Visual Studio, Visual Safe Source, ActiveX, SQL server and queries, client-server applications, PC architecture, extensive general computer skills, web site design and web applications, ASP.NET, Silverlight Tools, real-time data acquisition, computer system validation, MS Office including MS Access, MS Project, HTML, Statistical packages, MS Visio. Optimized existing procedures and wrote new systems from scratch.  Created design, performed testing, provided training, supervised integration, implementation, compatibility testing, database programming, installation, deployment, administration, customer support, backup/recovery, and troubleshooting of computer-based systems.
•    Academic background in bioengineering and mechanical engineering. Solid experience in scientific editing, science, statistics, mathematics and biology. Fluent in English, Russian and Hebrew.

PROFESSIONAL EXPERIENCE/ACCOMPLISHMENTS

•    Has edited a very popular “Pharmaceutical Process Scale-Up” handbook (3rd edition published in 2011), and has contributed chapters on “Tablet Press Instrumentation” and “Wet Granulation: End-Point Determination and Scale-Up” in the Encyclopedia of Pharmaceutical Technology.
•    Was teaching various training courses and seminars on wet granulation, tableting and regulatory compliance, including workshops for FDA and AAPS. Conducted numerous presentations on the functionality and benefits of instrumented equipment, process monitoring, principles of Scale-Up and Post-Approval Changes (SUPAC) guidance and Process Analytical Technology (PAT).
•    Successfully operated an engineering company specializing in instrumentation of solid dosage pharmaceutical equipment, providing technical and organizational leadership.
•    Created the “Advanced Instrumentation Monitor” hardware and software package that became industry standard in pharmaceutical R&D. This package helped save over $3,000,000 annually in raw material evaluation alone for such Fortune 500 companies as Bristol-Myers Squibb, Novartis and Pfizer.
•    Was involved in numerous instrumentation, process optimization, technology scale-up and transfer, validation projects within GMP framework for dozens of major pharmaceutical and chemical companies throughout USA, Europe and elsewhere.
•    Was responsible for Quality Assurance, Quality Control, risk assessment, cGMP regulatory compliance, validation and audit of computer systems, analytical instrumentation, and monitoring and control of solid-dosage equipment.
•    Vast practical experience as a technical writer. Created numerous Standard Operating Procedures, Validation Protocols, Acceptance Criteria and Testing Protocols, Installation, Operational and Performance Qualifications for Instrumented Systems, Quality Control reports and Documentation for Regulatory Compliance.
•    Experienced in pharmaceutical technology transfer, powder mixing and compaction technologies, tablet and capsule manufacturing processes, process failure resolution, and regulatory SUPAC compliance. 
•    Project engineering experience in Data Acquisition and Control instrumentation for R&D, scale-up and manufacturing of pharmaceutical solid dosage forms. Was handling various capital projects including budget justification, vendor selection, integrated system testing, startup/commissioning and final systems acceptance. Responsible for achieving the project objectives in close cooperation with pharmaceutical and chemical customers.
•    Ph.D. in BioEngineering/BioMathematics

EMPLOYMENT HISTORY

Mar 2010 – current   
Part-time VB Senior Developer/Consultant at Bristol-Myers Squibb Pharmaceutical (New Brunswick, New Jersey), DBA A PRIVATE Pharmaceutical Technology Consulting COMPANY.
A consulting project involving a user interface for a MATLAB-based computing and plotting engine. Created a stand-alone executable written in VB6 that accepted user input and generated Excel-based reports and graphs. The system has help balloons that show up on demand when mouse hovers over input fields, and all user entries are validated to comply with the required ranges.  The system was tested on XP, Vista and Windows 7 computers.  Also consulting on interpretation of results from an instrumented roller compactor.

1985 – 2010     
General Manager at Metropolitan Computing Corporation (East Hanover, New Jersey). 
Making unique real-time data acquisition systems for pharmaceutical industry. Specialized in scale-up of tableting and granulation unit operations.

1983-1985    
Programmer-consultant with projects at Warner-Lambert (Morris Plains, New Jersey), Sandoz (East Hanover, New Jersey), and Merck (Rahway, New Jersey).
Projects included software development and documentation for instrumented tablet press and a number of control systems for solid dosage equipment. 

1980-1982    
Research Associate at University of Houston (Houston, Texas)
Department of Mechanical Engineering and Physiological Fluid Mechanics Laboratory.
Specialized in computer simulation and mathematical modeling of a steady-state flow of viscous fluids and hematocrit distribution in capillaries. Developed a computer program for stochastic network analysis of fluid flow in micro-vessels.

1977-1980    
Research Associate at University of Washington (Seattle, Washington)
Center for Bioengineering, Center for Quantitative Science
Specialized in application of linear control theory to computer simulation and mathematical modeling of life processes.

EDUCATION   

1982     Postdoctoral studies, Department of Mechanical Engineering, University of Houston, Houston, Texas.
1980      Ph.D., Biomathematics, Department of Bioengineering, University of Washington, Seattle, Washington.

PUBLICATIONS, PATENTS AND PRESENTATIONS: available upon request

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