North Central US Region - Madison Wisconsin Section (1317)

Meeting Overview

This meeting will feature how to calibrate and maintain pipettes at your facility, with an analysis of Gage R&R of the process; and will also include Basic Training for New Calibration Technicians, followed by a Top 10 List of FDA 483s on calibration write-ups.

Topic: Gage Repeatability and Reproducibility: A Workshop in Measurement Variation Featuring Pipette
Speakers’ Name: John Roethke – Currently the Lead Metrologist at Exact Sciences in Madison Wisconsin. John has been active in validation and calibration for the pharma/biotech field for 20 years.
Speakers’ Name: Keela Sniadach – holds an ASQ CCT and has worked within the Promega Metrology department for 15 years in a variety of roles.
Calibration
Abstract: The workshop will give an introduction to and the details regarding pipette calibration at Promega including a demonstration using the Mettler XP26PC pipette calibration balance. The presentation will then lead into the fundamentals of Gage Repeatability and Reproducibility. The Gage R & R study will go through the process step by step with several real world examples using pipettes. The intent is to give the attendee the information necessary to set-up a study using their company’s measurement processes.

Topic: Basic Training for New Calibration Technicians in the Biopharma & Medical Device Industries
Speakers’ Name: Jay L. Bucher, Ph.D., started his calibration and metrology career with the U.S. Air Force's Precision Measurement Equipment Laboratories (PMEL) program, is a Senior member of ASQ, an ASQ Certified Calibration Technician (CCT), and an NCSLI section and region coordinator.
Abstract: Most biopharma and medical device companies give calibration responsibilities to the lowest ranking member of their quality assurance department. That is how it used to be done, but this is the 21st Century and times have changed. A quality calibration program, no matter if all their test equipment is sent out for calibration/repair, or accomplished in-house, must include a training program which is a mandatory requirement under ISO standards and FDA regulations. This presentation provides the basic training needed to get started in the right direction for any calibration/metrology department.
Learning Objectives: The learning objectives for this workshop are: The real meaning of calibration and traceability; what the standards and regulations actually say; facts and myths about calibration and traceability; the five steps of a quality calibration program.

Topic: The Top 10 List – Best Lessons Learned from FDA Warning Letters
Speakers’ Name: Jay L. Bucher, Ph.D., established Bucherview Metrology Services, LLC in 2002, and has consulted for clients ranging from NIST to a third-party one-man calibration function, including more than a dozen Fortune 400 companies. With more than 40 years in the metrology career field managing USAF PMELs, an FDA and ISO 13485 regulated metrology department, and training calibration personnel with 60 days to 60 years of experience, Jay brings a unique perspective to quality training to meet traceable calibration requirements. Jay is the editor and coauthor of the initial 2004 publication of The Metrology Handbook, and contributor and team leader for the review and update of the 2nd edition, and authored six additional books with the latest being A Calibration Training Program For The 21st Century. Jay has a B.S. and M.S. in Electronics Technology, and his Ph.D. in Traceable Calibration Technology.
Abstract: The current regulatory climate is intense as the U.S. Food & Drug Administration (FDA) has ratcheted up their compliance oversight with more Warning Letters being sent to Healthcare companies. Warning Letters are issued only for violations of regulatory significance. The good news is that the FDA publishes all Warning Letters on their web site as a public service. And they have a very easy search engine that allows you to find Warning Letters that contain topics particular to your industry or job. This presentation reviews calibration related FDA Warning Letters generated over the past five years. We will analyze the top ten best Warning Letter examples and discuss best practices that would avoid these violations. With this knowledge, we can learn from these violations and ensure that our metrology programs do not negatively impact the cost of quality of our organizations.

Speakers’ Name: Walter E. Nowocin, PEM, has 29 years of experience in the field of metrology with Medtronic, Inc., a global medical device manufacturer as a Senior Engineering Manager, and with the United States Marine Corps as a PMEL technician, technical instructor, and calibration lab manager. Walter is a Member Delegate to NCSLI representing Medtronic, he is a member of the NCSLI Twin Cities Steering Committee, and he is the Chair of the NCSLI Healthcare Metrology Committee. Walter has a Masters in Engineering Management degree from St. Cloud State University, Minnesota and is an Adjunct Professor with St. Cloud State for the Engineering Management graduate program teaching Management of Technology and Innovation. He recently attained his Professional Engineering Manager (PEM) certification from the American Society for Engineering Management.

Meeting Schedule:

8:00 AM - 8:45 AM Registration and get acquainted

8:45 AM - 9:00 AM Introductions and logistics

9:00 AM - 11:00 AM Gage Repeatability and Reproducibility: A Workshop in Measurement Variation using Pipette Calibration to demonstrate Key Features of Analysis of Variation.
- John Roethke (Exact Sciences)
- Keela Sniadach (Promega Corp.)

11:00 AM - 11:15 AM Group picture and door prizes

11:15 AM - 12:15 PM Lunch

12:15 PM - 12:30 PM NCSL International updates

12:30 PM - 1:30 PM Basic Training For New Calibration Technicians in the Biopharma & Medical Device Industries
- Jay L. Bucher, Ph.D. (Bucherview Metrology Services, LLC)

1:30 PM - 2:30 PM The Top 10 List – Best Lessons Learned from FDA Warning Letters
- Walter Nowocin (Medtronic, Inc.)