Blog

Marcus McNeely, who is a long-time Blue Mountain employee, recently accepted the role of Vice President of the Northeastern US Region of The National Conference of Standards Laboratories International (NCSLI).  Marcus has been an active volunteer in NCSLI for many years and previously served as the Chair of the NCSLI Healthcare Metrology Committee (the 151 Committee).

As the chair of the Healthcare Metrology Committee, Marcus was an active driver of generating regulatory advocacy documents, actively approaching regulatory bodies and reaching out to service providers.

One of the largest accomplishments of the Committee while Marcus was chairing, was the writing of an advocacy document for the FDA on the acceptance of ISO 17025 ILAC accredited calibrations. The 151 Committee advocated FDA recognition of the compliance of accredited calibration laboratories.  The group’s basis for this was that ISO 17025’s requirements are largely parallel 21 CFR requirements for measurement traceability, and recognition stated in a guidance document would foster abbreviated and /or remote qualification activities on behalf of a regulated contracting agency. The advocacy also stressed that contracting 17025 calibrations should be voluntary. Many of the FDA’s own labs are ISO 17025 accredited and voluntary contracting of such service providers was already recognized in a draft guidance document for testing laboratories.

This advocacy document was turned over to the Office of Regulatory Affairs (ORA) within the FDA. Obviously, the desired outcome is that the FDA will write a guidance document that recognizes the requirements of ISO 17025 and that through ILAC accreditation these laboratories have demonstrated that they have a quality program for measurement traceability back to the international system of units (SI).

This type of advocacy work is on-going.  Below is more information on Marcus McNeely, NCSLI and the Healthcare Metrology Committee (taken from the NCSLI website).

 

Marcus McNeely
Business Process Analyst

Marcus McNeely has been in the field of Biotech and Pharmaceutical metrology and validation for over 20 years.  As a Business Process Analyst with Blue Mountain Quality Resources, Marcus consults with biotech, pharmaceutical and medical device companies on best practices in every step of establishing, managing and maintaining a calibration program. Marcus is the Vice President, Northeastern US Division of NCSL International.

 

About NCSLI (from NCSLI website)

NCSL International is, as our tagline indicates, an organization serving the world of measurement. We also want to make sure that we are best serving our members by engaging and focusing on the right activities that support our mission and vision.

NCSL International was formed in 1961 (as The National Conference of Standards Laboratories, dba, NCSL International) to promote cooperative efforts for solving the common problems faced by measurement laboratories. Today, NCSL International has over 1000 Member Organizations from academic, scientific, industrial, commercial and government facilities around the world. This wide representation of experience provides Members a rich opportunity to exchange ideas, techniques and innovations with others engaged in measurement science.

NCSL International is a nonprofit organization, whose membership is open to any organization with an interest in the science of measurement and its application in research, development, education or commerce.

About the Healthcare Metrology Committee (151 Committee) (from NCSLI website)

Committee Charter
Promote and advance the practice of Metrology in the manufacture and use of pharmaceuticals, medical devices and instrumentation. Establish liaisons with practitioners, manufacturers and regulatory agencies, as well as professional, and industrial associations within the Healthcare community, to communicate the expertise and knowledge of Metrology advocated by NCSL International.