$20 – $40

ASQ NCDG March 2019 Roundtable Back to Basics – Calibration

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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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Back to Basics – Calibration

What is so basic about calibration?

Calibration is the foundation for all medical measurements!

Wednesday, March 27, 2019 7:00 - 9:00 PM


Topic: Back to Basics - Calibration

ASQ NCDG will be discussing Calibration as regulated by FDA 21 CFR 820 Subpart G – Production and Process Controls, section 820.72, and ISO/IEC 17025:2017, General Requirements for Calibration. Thomas will present an overview of calibration and the standards governing calibration. He will also present guides to successful calibration procedures, documentation and will delve into the issue of accuracy or more correctly the term “uncertainty” as it is associated with calibration metrics. The presentation will end with a section on tips and tricks to get the most out of a calibration program and system and hints on how to pass the scrutiny of an ISO audit of your calibration program.pic:



Featured Speaker:


Thomas Lypka, BScME, has 50+ years of experience in design engineering and development in a wide variety of disciplines including all aspects of pharmaceutical and medical device quality, manufacturing and sterilization research and development including the design, construction and certification of CERs. Currently, Thomas has his own consulting firm and specializes in heading medical device companies under Warning Letter status by FDA. Most recently, Thomas was certified as Lead Auditor for ISO 13485:2016 under the BSI Lead Auditor training program. Thomas built and staffed his first calibration lab in 1978. He has worked with many well-known companies and start-up companies in the Chicago and Bay Areas. He also has an extensive background in steelmaking, internal combustion engine design and development and management of large organizations. Thomas completed executive education for Management of Managers at the University of Michigan in 1975. He also completed the Quality Assurance program from D’Anza College in Cupertino in 1995.

Moderator: Gary Seeger, Vice President, Stellartech Research Corporation, BSME, and ASQ CRE, CQE.

Location: Stellartech Research Corporation, 560 Cottonwood Dr., Milpitas, CA 95035

Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.

Email: To be added to or removed from our email list, contact George Marcel (gjmarcel@gmail.com).

Registration Link: http://ncdgmar019.eventbrite.com

ONLY Credit Card accepted at door via Eventbrite

Questions: For information about this session, contact Anesh Tilwani (Anesh.tilwani@gmail.com).

Formal discussion and questions will end between 8:30 - 8:40 pm to allow time for networking.

Materials: Presentation & workshop sheets provided for onsite attendees only. Please limit distribution to attendees: personal professional use only.

Webinar Remote Access (no cost):

https://attendee.gotowebinar.com/rt/8290285084177151234







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Date and Time

Location

Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

View Map

Refund Policy

Contact the organizer to request a refund.

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