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 Expert  729137

Expert in Near Infrared Spectroscopy, Multivariate Analysis, Pharmaceutical Analysis, (GMP)


Available for your Consulting and Expert Witness Needs

Maryland (MD)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert is an Internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods including near infrared and multivariate analysis. Nineteen years of industry experience with increasing responsibility and five years of policy experience. USP Scientific Fellow with the United States Pharmacopeia (USP) and Liaison to the General Chapters, Pharmaceutical Waters and Statistics Expert Committees. USP in-house expert on the FDA Process Analytical Technology and Quality by Design Initiative. He has liaised with government and industry stakeholders on compendial analytical, pharmaceutical waters, and statistical policies.

Expert has made many significant contributions in the field of Near Infrared (NIR) Spectroscopy, having presented, and published over sixty papers including four book chapters. Expert is co-developer and co-author of several pharmaceutical analysis process measurement patents. He also is a member of the Society for Applied Spectroscopy, The Coblentz Society, and the Council for Near Infrared Spectroscopy. He chaired the International Diffuse Reflectance Conference in 2006. From 1999 to 2001, he served as a secretary of the New York Section, Society for Applied Spectroscopy. Expert serves on several scientific advisory panels for several companies and editorial boards.

Expert received his Master of Science and Bachelor of Arts in Biology from the University of Bridgeport.

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applied spectroscopy

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chemical analysis

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diffuse reflectance spectroscopy

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near-infrared spectroscopy

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vibrational spectroscopy


Education:
Year   Degree   Subject   Institution  
1983   MS   Biology, Molecular Biology, Clinical Chemistry   University of Bridgeport  
1981   B.A.   Biology   University of Bridgeport  

Work History:
Years   Employer   Department   Title   Responsibilities

2008 to

 

(Undisclosed)

 


 

Consultant, Scientific Affairs

 

Expert provides in-house scientific expertise with hands-on pharmaceutical industry experience. Expert provides Expert's Firm management and its clients with advice, support, and leadership in the creation, coordination and delivery of Anti-Counterfeiting solutions, Hospital verification system setup,Analytical instruments, and Consultation, Training and Support programs and services. Expert's Firm Scientific Affairs strategy is structured to guide the development of Expert's Firm programs and services through Operations and Project Support as well as Life-cycle management. Expert has demonstrated industry leadership with expertise in developing, directing and coordinating innovative analytical solutions in pharmaceutical analysis. He is the former Scientific Fellow for Process Analytical Technology (PAT) for the United States Pharmacopeia, Documentary Standards Division. In that capacity, he assisted in the development of process analytical policy for the USP. For General Chapters, Pharmaceutical Waters, and Statistics Expert Committees, he had oversight over the development, revision and maintenance of over thirty general chapters and monographs that these expert committees support. He coordinated with government and industry stakeholders on compendial analytical, pharmaceutical waters, and statistical policies. As a lead investigator in the Applied Compendial Research Group, he developed, and implemented experimental protocols for spectroscopy, pharmaceutical water, and statistical experiments, especially using multivariate analysis. He conducted multi-laboratory studies with US FDA and private laboratories to develop reference standards, conduct inter-laboratory studies in Near Infrared (NIR) Spectroscopy on the construction of NIR spectral libraries on multiple NIR spectrophotometers across multiple laboratories for the detection and identification of counterfeit pharmaceuticals. He chaired the ASTMI E13.11 subcommittee on Multivariate Analysis, and is a former member of ASTMI Committee E55 on Pharmaceutical Application of Process Analytical Technology. He serves on the Editorial Advisory Boards of Pharmaceutical Manufacturing and American Pharmaceutical Review. He was co-developer and co-author of several pharmaceutical analysis process measurement patents using spectroscopy. His multi-disciplinary expertise includes current good manufacturing practices, all facets of FDA product and process regulatory compliance documentation, validation and data submission.

2003 to 2008

 

United States Pharmacopeia

 

Divsion Standards Development

 

Scientific Fellow for PAT

 

Served as liaison for United States Pharmacopeia, General Chapters, Pharmaceutical Waters, and Statistics Expert Committees, plus additional international government agencies and the pharmaceutical industry.

Worked to establish parameters for management consideration of Process Analytical Technology to compendial policy.

Recommended experts in spectroscopy and analytical chemistry to populate General Chapter and Reference Standards Expert Committees. Managed study as lead investigator on multi-laboratory project including U.S. FDA and private laboratory.

Supervised study for the development of Near Infrared Spectral Libraries on multiple NIR spectrophotometers

Developed, drafted and directed study protocol; drafted instrument and model standards for developing, maintaining, and transferring chemometric methods between laboratories. Represented USP at PAT related symposia, conferences, and USP sponsored events.

Led efforts to develop, revise, and publish the final USP General Chapter on Near Infrared Spectroscopy

Oversaw 30 new and revised general and informational chapters.

Developed nine pharmaceutical water monographs, three general and informational chapters, and two new and revised general and information chapters.

1991 to 2003

 

Purdue Pharma

 

Analytical Research and Development

 

Principal Scientist

 

Supported the analytical method development for chromatographic, spectroscopic, Potentiometric titrations, and dissolution analysis.

Worked with US FDA regulations.

Utilized US Code of federal regulations parts 58, 210, and 211, in the creation, review, and implementation of pharmaceutical standard operating procedures.

Produced required validation reports and analytical subsections for use in new drug applications, abbreviated drug applications, and Chemistry Manufacturing & Controls procedures.

Conducted pharmaceutical clinical studies, packaging verification, and product identification groundwork.

Supervised the Process Analytics Technology group for the development and implementation of the Process Analytical Methods; performed 21 Code of Federal Regulations-Part 11 validation audits.

Introduced new NIR spectroscopy technique to Research & Development; applied feasibility testing to company products; purchased equipment, performed calibration, and installed qualification program.


Career Accomplishments:
Associations/Societies

Society for Applied Spectroscopy;

American Chemical Society;

Coblentz Society;

Council for Near Infrared Spectroscopy.


Publications:
Publications and Patents Summary

Expert has over 60 publications (four of which are book chapters) and invited presentations and is a holder of four patents for the use of NIR techniques.

Selected Publications and Publishers  
 - Journal of Near Infrared Spectroscopy  
 - Journal of Pharmaceutical and Biomedical Analysis  

Consulting Services:
Selected Consulting Examples:
  • Perform analysis for the development of drug substance and products using process analytical technologies, quality by design and multivariate techniques.Solvent and moisture drying of API using NIR and PLS.Four Step API Synthesis using Mid-IR.Thin film deposit on final product dosage patch using NIR.Involved in the modeling and implementation of real time drying, content uniformity, and monitoring drug synthesis for commercialized products as well as new drug substance under development.
  • He formulated and developed a quality master plan for a Testing Laboratory Facility to address GMP deficiencies in their methods, instrumental qualifications, and quality specifications. along with former FDA associate consultant, we proposed and implemented a strategy for compliance in two phases. Phase one involved performing a gap analysis for compliance with FDA current Good Manufacturing Practices as applicable to testing laboratories for pharmaceutical products. the initial work focused on meeting with the client to scope out the assessment, auditing the laboratory and reviewing laboratory processes and systems, and preparation of a final report identifying areas requiring revision and updating. Phase two resulted in a remediation plan that addressed the finding in the gap assessment and laboratory audit that resulted in provide guidance and training to the clients laboratory personnel personnel and company management with regard to SOPS, overall Quality System, analytical method development, analytical method validation and verification, equipment qualification and calibration, personnel qualification and training, and some other miscellaneous areas that were identified during Phase I. The facility is now awaiting FDA inspection for a compliance statement of readiness for release testing.
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:
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.

Market Research:
Expert in compendial monographs and general chapters. Expert has practical as well as policy experience with GMP, ICH of pharmaceutical regulatory science. He was instrumental in discussions for policy development of process analytical technology, and quality by design approaches for pharmaceutical manufacturing technologies.

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.

 

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