traceable calibrations, FDA regulations, FDA regulation training, FDA pharmaceutical regulation, 21 CFR Part 820, calibration standards, ISO calibration, FDA cGMP regulations, FDA compliance, FDA cGMP, paperless records, 21 CFR Part 11, calibration procedures, calibration traceability, quality calibration program, a paperless calibration department that meets biotech, pharmaceutical, and medical device reqirements, paperless calibration compliance for national and international standards and regulations, virtual calibration workshops


Bucherview Metrology Services

Jay L. Bucher started Bucherview Metrology Services in 2002 as a calibration/metrology consulting and training company. Clients have ranged from a one-man third party calibration function to the Technical Services Division of the National Institute of Standards and Technology (N.I.S.T.). As the President and Chief Calibration Officer, Dr. Bucher has more than 40 years experience in the calibration and metrology career field. He successfully held positions in United States Air Force's Precision Measurement Equipment Laboratories (PMEL) ranging from bench technician to section supervisor, and from the Quality Assurance Manager to the Senior Calibration Laboratory Manager. He has also held positions as Senior Metrologist with Raytheon Middle East Systems (RAYMES) in support of the Royal Saudi Air Defense Force PMEL, and Manager of Metrology Services for a world leading biotechnology company. Starting in 1997 he developed, implemented and managed a ‘Best-in-Class’ metrology and calibration program that exceeded the standards of ISO 9001 and ISO 13485, and also met the requirements for cGMP (the FDA's QSR) for medical devices. He developed a paperless records system in 1999 for the data collection, storage and retrieval of their calibration records. He upgraded their paperless system to be wireless in 2005, and to meet 21CFR, Part 11 requirements in 2006.

Dr. Bucher now conducts virtual paperless calibration workshops through Bucherview Metrology Services, on-site workshops, and workshops during the Measurement Science Conference held annually in March, and during their Fall Tutorials in October, in California. He has also consulted, trained, and conducted workshops for more than a dozen Fortune 400 companies in the United States and Puerto Rico, with attendees ranging in experience from 60 days to 60 years. For more information, please see the Services section of this website.

Dr. Bucher has been a member delegate for the National Conference of Standards Laboratories (NCSL) International since 1997. He started the Madison Wisconsin Section of NCSL International in 2000, and is their section coordinator. He is also the North Central U. S. Region Coordinator. He received the Section/Region Coordinator of the Year Award from NCSL International in August 2006. He has presented papers, hosted sessions, and conducted tutorial workshops at seven NCSL International Workshop & Symposiums, along with numerous presentations at section meetings in the Twin Cities, Chicago, and Madison, WI.

He has also presented papers at the Measurement Science Conference (MSC) on several occasions. He has conducted tutorial workshops on meeting the FDA requirements for traceable calibration in biotech, pharmaceutical, and medical device companies at both NCSLI and MSC conferences, as well as workshops on Paperless Records.

As a Senior Member of the American Society for Quality (ASQ), Dr. Bucher stays active in the Measurement Quality Division (MQD) of ASQ. He is the current Secretary (2012 ~ 2013), and Immediate Past Chair (July 1, 2009 ~ December 31, 2011) and holds the positions of Chair, CCT sub-committee, Publications Chair, Share Point Administrator, Standards Committee Representative, and website liaison. He is also the Managing Editor and Publisher of The Standard, the quarterly newsletter of MQD. He took The Standard to being totally electronic with quarterly editions starting in 2005. He received the division’s highest honor, The Max J. Unis Award in 2004 for his leadership in The Metrology Handbook project.

Dr. Bucher earned his CCT (Certified Calibration Technician) certification in June 2003. He is listed as an SME (Subject Matter Expert) for the CCT writing and review workshops. As the Chair of the CCT certification subcommittee, he has been active in updating and improving the exam items since the CCT was approved by ASQ. Dr. Bucher is also an Editorial Advisor for Cal Lab Magazine, reviewing articles pertaining to calibration and metrology applications in the biotechnology, pharmaceutical, and medical device industries.

Dr. Bucher has authored six books...
  • The Metrology Handbook (Editor and coauthor), ISBN-13: 978-0-87389-620-7, available here;
  • The Quality Calibration Handbook: Developing and Managing a Calibration Program; ISBN-13: 978-0-87389-704-4; available here;
  • Paperless Records: Designing and Creating Your Own Electronic Forms; ISBN-13: 978-1-60402-103-5;
  • Ethics - The Final Frontier, ISBN-13: 978-1-61539-106-6;
  • Paperless Calibration Compliance For National and International Standards & Regulations, ISBN-13: 978-1-4507-3546-9, available here.
  • A Paperless Calibration Department That Meets Biotech, Pharmaceutical, & Medical Device Requirements, ISBN-13: 978-1-4507-5782-9, available here.

Education/Certification:

Distinguished graduate, US Air Force Technical Training School: 3ABR32430,

Precision Measurement Equipment Laboratories (PMEL) - May 1972

Distinguished graduate, 22nd Air Force NCO Leadership School,

Norton Air Force Base, CA - December 1977

Graduate, Pacific Air Force's NCO Academy,

Kadena Air Base, Okinawa - February 1985

Distinguished Graduate, USAF First Sergeant's Academy correspondence course - September 1989

Graduate, USAF Sr. NCO Academy correspondence course - November 1989

Received 'Nine-level' certification, and authorized to wear the USAF Master Munitions and Maintenance Badge - November 1989

B.S. in Electronics Technology from Almeda University, June 1997

Certified by the American Society for Quality (ASQ) as a Certified Calibration Technician (CCT), June 2003

M.S. in Electronics Technology from Almeda University, June 2004

Ph.D. in Traceable Calibration Technology from Almeda University, May 2011

 

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Photo courtesy of Yumi. Copyright © 2006