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Back to Basics: Understanding the Fundamentals of Quality Technology - ASQ...

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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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Back to Basics - Understanding the Fundamentals of Quality Technology

Wednesday, January 23, 2019, 7:00 to 9:00 pm


Topic: Back to Basics

Over the past couple of decades, the focus of medical device quality assurance has been regulatory process compliance and the attending documentation. We may have lost focus on the fundamentals of quality technology. Quality engineering and quality technology create the architecture and foundation underlying documentation processes such as the QSR and ISO 13485. These regulations point out in general what we are supposed to do, but do not touch specifically on how to do it. Medical device quality professionals should have the detailed knowledge of statistics, sampling, metrology, reliability, process control, calibration, and the other elements that comprise fundamental quality engineering. People and capability underlie the effectiveness of any processes that are put in place. This roundtable is meant as an overview of the technical tools available to minimize variation and assure repeatability of product quality and hopefully encourage the medical device quality professional to get back to basics.

Featured Speaker:

Gary Seeger is the Vice President of Quality Assurance and Regulatory Affairs at Stellartech Research Corporation. Gary is an ASQ CQE (1974) and an ASQ CRE (1980). He holds a BS in physics from Harvey Mudd College and an MBA from UCLA. Gary has been on the Biomedical Discussion Group Board for over 20 years and has 45 years of experience in pharmaceutical and medical device quality assurance and regulatory affairs.

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Moderator:

Barry Craner, former Vice President (QA/RA), Stellartech Research Corporation, former Chair, ASQ Biomedical Division, MS+, MBA, CQE, CRE, CQA, CBA, RAC(US), on the ASQ Northern California Biomedical Discussion Group Board since 1993, with 40 years experience in engineering and medical device QA and RA, and consults in medical device risk management.

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: NCDGJAN2019.eventbrite.com

ONLY Credit Card accepted at door (via Eventbrite)

Questions: For information about this session, contact Gary Seeger (gseeger@stellartec.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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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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