Expert Details

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

Expert ID: 729137 Maryland, USA

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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. 19 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.





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.

Expert may consult nationally and internationally, and is also local to the following cities: Baltimore, Maryland - Frederick, Maryland - Gaithersburg, Maryland - Bowie, Maryland - Reading, Pennsylvania - Lancaster, Pennsylvania - Wilmington, Delaware - Alexandria, Virginia

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Education

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

Work History

Years Employer Title Department Responsibilities
Years: 2017 to Present Employer: Undisclosed Title: Lead Consultant Department: Responsibilities: Support cGMP and Preventative Controls implementation of Food Safety Modernization Act (FSMA) at the manufacturing facility. Provided cGMP audit and gap analysis of quality system. Provide support for quality group for cGMP training, process equipment and laboratory instrument qualification and analytical method validation.

RESPONSIBILITES:
• Trained senior management team on current good manufacturing practice
• Instruct senior management team on instituting quality systems management approach for manufacturing and laboratory facilities
• Write and train staff on standard operating procedures (SOPs) for management responsibility, quality management system policy, standard operating procedures and SOP template.
• Ongoing support for SOP writing and reviewing, quality management, and continuous auditing for compliance to FSMA and cGMPs.
Years: 2015 to 2017 Employer: Dynalabs, LLC Title: Director of Operations Department: Responsibilities: Reporting to the Chief Operating Officer and as a member of the executive team, in a change management role implemented operational excellence principles to effect continuous improvement that resulted in $1M monthly revenues in less than one year and multiple and consecutive $1M monthly revenues since then. Specific deliverables are:

• Revised and created new standard operating procedures to train or retrain, empower staff, samples and information to reestablish accountability and enhance customer service. Achieved 100% sample delivery to their intended targets and sample testing. Working with microbiology and chemistry managers and supervisors, he focused those teams on optimizing people performance, correcting, creating or eliminating process controls and creating or modifying procedures (SOPs) to attempt to effect 0% deviation, IR's and 0% sample loss with dramatic gains being made in all three divisions.

• Incorporated management and operation excellence tools into his toolbox that relate back to the following management categories: Planning, Budgeting and economic management, work flow and organization, compliance, problem solving, evaluation and control and finally risk management. The operations management team led by the COO and the Director of Operations managed several major initiatives in chemistry, microbiology and sample management in last quarter of 2015 and the first through third quarter 2016.

• Relocated the chemical laboratory from the first floor to the second floor with minimum impact from January 2016 until August 2016, Expert has refocused his efforts on incorporating management tools into his toolbox that relate back to the following management categories: Planning, Budgeting and economic management, work flow and organization, compliance, problem solving, evaluation and control and finally risk management. Expert and the operations management team are managing several major initiatives in chemistry, microbiology and sample management.

• Led the creation, development and implementation of the environmental, health and safety (EH&S) program impacting sample management, microbiology and chemistry operations. System optimization included solvent and waste transport from 1st to 2nd floor and vice versa using the elevator, solvent management and storage in the laboratory and media destruction management resulting in eighteen thousand dollars ($18k) savings annually.

• Led chemistry personnel in setting up, implementing and organizing the laboratory using the 5S system.

• Facilitated coordinating the Quality Assurance/Laboratory Operations Investigational Reporting of OOS by helping to repurpose a key analyst to quality to help minimize and facilitate closing of OOS issues in the chemistry laboratory.

• Microbiology underwent a dramatic staff turnover and Director of Operations worked with the management team to help facilitate and guide them through to stabilization period. With many controls implemented to minimize and eliminate sample loss, he has been managing with the microbiology and executive management team, phase II expansion, new testing services, EHS and waste programs, and coordinating application of testing new decontamination steps in the clean room.

• Sample management has seen the most change with the coordinating and training on the newly implemented bar coding system which brought with a major change in how samples are handled. This required major revisions to the sample management SOPs and these have all been written and revised. Staffing was a challenge but with management’s assistance, staffing was brought under control.

• Facilitated research and marketing for outsourcing testing on biologic compounds, developing, auditing and establishing a partnership with a leading domestic laboratory

• Facilitated research and marketing for testing state regulated cannabis products. Provided due diligence on current capacity, competitor pricing and market forecast.
Years: 2008 to Present Employer: Undisclosed Title: Director, Scientific Affairs Department: Responsibilities: Expert provides in-house scientific expertise with hands-on pharmaceutical industry experience. Expert provides InfraTrac 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. InfraTrac Scientific Affairs strategy is structured to guide the development of InfraTrac 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.
Years: 2009 to 2014 Employer: Infratrac Title: Consultant Department: Responsibilities: Lead consultant to client providing instrument qualification and validation, method development, program implementation and support for real time raw material inspection using Near Infrared and Raman spectroscopy. Primary focus was to provide oversight on the development of the sampling program, computer system validation and systems training, worked with client quality department to write SOPs for program OOS investigations. CAPA implementation, auditing, risk assessment, program management and delivery of GDP training for reduced testing program.

RESPONSIBILITES:
• Served as consultant and subject matter expert in spectroscopy and chemometric for operational and performance qualification, computer system validation and quality requirement documentation (e.g. user requirements, risk assessment, Part 11 assessment and traceability matrix) for raw material identification by Raman and NIR spectroscopy
• Audited site for CGMP compliance and alignment to 21 CFR 11, 210 and 211 and FDA guidance
• Provided site remediation and training for related CGMP requirements for reduced testing program
• Implement and instruct quality assurance on interim controls and remediation of their quality systems management approach for CGMP
Years: 2003 to 2008 Employer: United States Pharmacopeia Title: Scientist Fellow Department: Divsion Standards Development Responsibilities: 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.
Years: 1991 to 2003 Employer: Title: Principal Scientist Department: Responsibilities: 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 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.

More information is available upon request.

Fields of Expertise

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