Volunteer Focus
Neil Greenberg, PhD, Manager, Regulatory Affairs, Ortho-Clinical Diagnostics, Inc.

You have been with Ortho-Clinical Diagnostics (OCD) for over 25 years.  Please tell me about the work you have done there.
I began my career in the diagnostics industry in 1978.  At that time, Ortho Diagnostics’ Clinical Chemistry franchise was part of the Eastman Kodak Clinical Diagnostics Division.  Until 1983, I worked as manager of the Kodak Corporate Clinical Chemistry Service Laboratory, a New York State-licensed clinical chemistry service lab that provided routine and special chemistry service for Kodak’s medical department.  In addition to providing routine laboratory services, we also developed clinical chemistry methods for rare analytes for special occupational medicine and toxicology programs, and conducted internal performance evaluation studies for Kodak’s commercial clinical chemistry systems.  Also, as a member of the Product Specifications Team on the Kodak Clinical Chemistry systems project, I assisted in the development of product performance specifications for the research and development teams.

And in the mid-1980s, you began to move into work that was more specifically focused on calibration?
Yes.  I managed a clinical chemistry reference methods development and service laboratory at Kodak from 1983 to 1985.  We supported research and development and manufacturing in calibration of Kodak’s commercial clinical chemistry assay systems.  From 1985 to 1988, I worked as Manager of the Calibration/Analytical Systems Group, which included a staff of engineers and scientists who were responsible for all aspects of commercial system calibration.  Later I became Manager of Manufacturing Support for Reagents Development and Manufacturing.

What type of work did you do in that position?
We developed specifications, quality control processes, and release tests for raw materials and components for reagent manufacturing, and also conducted product troubleshooting investigations and product formulation improvements projects.  In addition, we developed formulations, specifications, and QC/release processes, working with various contract vendors in manufacturing Kodak’s commercial calibrators and controls for its commercial clinical chemistry systems.  The group was also responsible for bottle value assignment processes for product quality control and calibrator fluids.

And you moved into Customer Quality from there.
Yes. In 1991, I became manager of the QA-Customer Quality group within the Technical Support and Complaint Handling Unit for both the clinical chemistry and immunodiagnostics franchises. 

What were the challenges you faced working in that unit?
I managed a group of senior chemists and engineers who worked closely with our Worldwide Customer Technical Services Department, identifying and resolving significant product performance issues. Because this area is often a major focus of regulatory inspections and quality systems audits, it was paramount that documentation was always complete and timely.

Tell me about your work in Regulatory Affairs for OCD.
In 1999, I became Manager, Regulatory Affairs for Clinical Chemistry Systems.  In this position, I’ve defined regulatory strategies for new systems and assured that regulatory requirements were met for new product launches.  I’ve also managed submissions for numerous FDA 510ks as well as international regulatory registration and licensing for over 60 new products.  I also served as Regulatory Affairs subteam leader for the Immunochemistry Systems Infectious Disease Program, responsible for preparation of instrumentation and software documentation sections for premarket applications (PMA) for infectious disease test kits. 

And you were involved in the European Union In Vitro Diagnostics Directive Project Team at OCD-Rochester?
Yes. I provided regulatory oversight for the OCD Rochester European Union In Vitro Diagnostics Directive Program.  This was a major undertaking that spread over several years, and involved updating technical documentation and labeling for hundreds of existing products, to ensure conformance to European Union requirements.

You are involved with a number of professional and standards-development societies outside CLSI.  Could you provide some details on these?
I’ve been active in the AACC (American Association for Clinical Chemistry) since 1974.  I served on the Standards Committee from 1986 to 1991, as Chair of the Upstate NY Local Section from 2000 to 2001, and as Co-Chair and speaker for an AACC Edutrak on Calibration Traceability in 2001 and again in 2004.  I’ve served as an invited reviewer for Clinical Chemistry (AACC’s International Journal of Laboratory Medicine and Molecular Diagnostics).  I’m a member of the ADVAMED IVD Standards Working Group, and have served as ADVAMED Representative to the Joint Committee on Traceability in Laboratory Medicine, which is an international steering committee for calibration traceability of IVDs.   I’m also a member of the Regulatory Affairs Professional Society (RAPS), since 1999.  Since 2002, I’ve served as the Diagnostics Industry representative to the Lab Standardization Panel in the National Kidney Disease Education Program, of the National Institute of Diabetes & Digestive & Kidney Diseases, for the National Institutes of Health.

How did you become involved in CLSI?
I became involved with CLSI when it was still NCCLS, around 1985.  At that time, the organization had a group in place called the Council for the National Reference System for the Clinical Laboratory. The Chairman of this committee was Royden Rand, and Dr. Rand was my supervisor at Kodak at that time.  So, my involvement with CLSI stemmed from a request from my boss to serve as an observer on this committee. Ultimately I became much more involved with the organization.   I served as Chair of the Subcommittee on Reference Materials for Serum Cholesterol from 1988 to 1993, and remained a member of that committee until 1999.  The committee authored the CLSI/NCCLS guideline C37—Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures.  Additionally, I served as an advisor on the Subcommittee on Electrolytes from 1986 to 2003.

And did your involvement with CLSI lead to your work in ISO (the International Organization for Standardization)?
Yes.  My involvement is with ISO Technical Committee 212 (ISO/TC 212), for which CLSI serves as secretariat.  I’ve been specifically involved with Working Group 2 (WG2) since 1996.  Working Group 2 is developing standards for calibration traceability, an essential requirement for CE-marked IVDs under the EU IVD Directive.

How does the increasing rate at which people are traveling and information is exchanged in our globalizing world threaten the uniformity of standards and accuracy of results?
I don’t think these trends threaten the uniformity of standards and accuracy of results at all.  On the contrary, I think they promote the desire for uniformity and have made global standardization more of a priority. I think more and more people are jumping on the bandwagon. 

What, as you see them, are the most important purposes behind the overarching goal of making methods for analyte detection traceable to a higher order of references?
The goal is to facilitate information and data exchange, which ultimately accelerates the rate of medical discovery.

What first interested you in your line of work, and what has sustained your interest?
When I was first working at Kodak running the service laboratory for the corporate medical department, there was significant interest in the clinical laboratory data on high health risk employee subpopulations.  The challenges and the shortcomings of existing data based on the current state of the art dramatically underscored the need for a better understanding of reference intervals and careful standardization of lab data.   

Describe the relationship between CLSI document X5-R (Metrological Traceability and Its Implementation) and the ISO documents 17511 and 18153.  What necessitated this report in particular with those standards already available? What should users know about X5-R that sets it apart and makes it necessary?
The development of X5-R was driven by certain constraints in the ISO world regarding what could and could not be included in ISO documents 17511 and 18153.  Ultimately, what the people who needed this information were asking for was a more practical guide that would provide them with specific examples to enhance implementation of the ISO standards. The need for this additional information is how X5-R came about.

I’m pleased to see CLSI involved in a project like X5-R which is a collaborative effort between CLSI and IFCC.  Overall, projects like this improve CLSI’s visibility on a global basis and add to the organization’s credibility outside the US. Projects like X5-R set a global tone for CLSI.   

"Volunteer Focus" is an eNews feature which focuses on Clinical and Laboratory Standards Institute volunteers from different areas of the healthcare community, and the contributions they are making to the patient-testing world through CLSI and their daily work.  To recommend a volunteer to be featured in an upcoming issue, e-mail Communications.

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