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6th Annual ASQ San Diego Quality Conference, EU MDR plus Compliance, Qualit...

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4795 Executive Drive

San Diego, CA 92122

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Refunds up to 30 days before event

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October 19 and 20 in beautiful San Diego, CA

ASQ Biomedical Division and the ASQ San Diego Section 703 are partnering to provide a truly international conference with high caliber speakers on a wide range of topics. A full day EU Medical Device Regulation MDR program, multiple Saturday topic tracks, and a Medical Device company tour.

Day 1, Friday

Tentative Agenda (current program is found at

8:00 - 8:30 Registration, Welcome of participants & Opening Address

8 30 - 10:00 Overhaul of the EU Medical Device(s) Regulation - Oliver Christ- Day 1 speaker

  • Why does Europe need a new MDR? – Objectives & Justifications

  • What are the main benefits for Patients & Consumers?

  • The “Big Five” changes > Implication for Medical Devices Manufacturer

10 00 – 10 15 Coffee-Break

10 15 - 11:30 “Fight for” Notified Body services under MDR in Europe – Disruption expected

11:30 - 1:30 Ilumina Tour & Lunch- separate registration required for tour

1:30 - 2:30 UDI, Labelling & Technical Documentation (affected products; materials)

2:30 - 3:30 Post-Market Surveillance & Post-Market Clinical Follow-up – What to do?

3 30 – 3 45 Coffee-Break

3 45 – 4 45 Road-Map for MDR Compliance – Countdown for May 26, 2020

4 45 – 5 15 Discussion & Summary of Day1

There will be a Friday night networking event at the Karl Straus Brewery:

Day 2, Compliance, Quality, and Culture

Tentative Agenda (current program is found at

8:00 - 8:30 Registration

8:30 - 9:00 Welcome and Opening Address, Gary Workman

9:00 - 10:30 KEYNOTE: A Step by Step Guide: How to align organizational culture when implementing a quality system, Jerry Mairani

10:30 - 11:00 Break

11:00 - 12:00 PANEL: Cross-Disciplinary Strategies for an Effective Quality Management System,
Walter Kuhns, Chuck Donlon, Keith Boyle, Nivaldo Diaz

12:00 - 1:00 Lunch

1:00 - 2:00 Tracks A, B, & C

Track A A3 Problem Solving, Mark Claywell

Track B Risk Management – Based on the ASQ CQE BoK; FDA Q9 Quality Risk Management, ISO 31000, & ISO 9001-2015, Mark Lindsey

Track C The Radical Paradigm Shift for your Operational Excellence Platform: Overcoming the Inertia of Analytics with Profound Intelligence, Therese Costich

2:00 - 3:00 Tracks A, B, & C

Track A Design Thinking Applied to Manufacturing Processes, Abe Cohan

Track B Design Control for Medical Devices – A Practical Approach for the New ISO 13485 Updates, Cinta Burgos

Track C QSR Compliance Quality, David Manalan

3:00 - 3:30 Break

3:30 - 4:30 Tracks A, B, & C

Track A Introduction to The MedAccred® Critical Processes Audit Program, Eliot Dratch

Track B MDSAP: What Does It Mean For Medical Device Manufacturers?, Alexander Crosby

Track C Leadership Styles and the Art of Six Sigma, Gary Miller


Two days of opportunities to network and learn with fellow professionals.

1.0 RU/CEU each day.

For sponsorship opportunities or or other questions, contact

Larry Miller, San Diego conference chair, or

Pam Goldstein, Biomedical Division conference chair,

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4795 Executive Drive

San Diego, CA 92122

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Refund Policy

Refunds up to 30 days before event

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