November 2017

Temecula Valley Section 0713

November 2017 Monthly Dinner Meeting

Topic: “Supplier Quality”

Who: Brandon Gosiengfiao

When: Thursday, November 16th, 2017 at 6:00 PM

Where: Temecula Library Community Room B

30600 Pauba Road,
Temecula, CA 92592

Dinner Cost: $20.00 for members
$25.00 for non-members

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Presentation Title: “Supplier Quality – The Ins and Outs of Process Validations at the supplier level: When to Do it and When you Can Get Away Without it”

Abstract: The Ins and Outs of Process Validations at the supplier level: When to Do it and When you Can Get Away Without it

  • Analyzing potential product impacts to accommodate supplier changes
  • Promoting constant and disciplined supplier communication to understand relevant changes
  • Minimizing disruption to the supply chain through timely revalidations to meet regulatory expectations
  • Managing the after effect of process changes to maintain product quality


Presentation Speaker: Brandon Gosiengfiao

Brandon Gosiengfiao has worked in the Medical Device industry regulated by the FDA per 21 CFR Part 820 for over 12+ years. His professional career in Quality Engineering includes the following medical device companies:  Abbott Vascular (formerly Guidant), Extrumed (supplier of medical device tubing), Carefusion (formerly Cardinal Health), Boston Scientific (formerly Cameron Health) and currently back at Abbott formerly St. Jude Medical as Sr. Supplier Development Quality Engineer. Brandon has worked in quality engineering in areas including production and process controls, design planning and controls and supplier controls and quality.

Brandon is from the Bay Area and a graduate from San Jose State University with BS Management and Minor in Industrial Technology. He is ASQ CQE certified and has completed the Green Belt program at Villanova University.  He has achieved numerous patents for the design of Guide Wires while at Guidant and Abbott. Additionally, Brandon has co-authored with Dr. Michael Whitt, Bioengineering Lecturer/Cal Poly San Luis Obispo which was published in The Handbook of Technology Management/Wiley: December 1, 2009 entitled Statistical Process Control.

Join us for a wonderful presentation of “Supplier Quality” on November 16th, 2017 at 6:00pm!!!

This eye-opening and invaluable discussion will give even seasoned auditors a new perspective, and will help improve the audit experience not only for clients, but also dramatically reduce problems with Certification Body internal review committees and Accreditation Bodies.
As a clinic participant, you will:
The “angle of perception” used by auditors, and how to expand it using the “missing senses” to soak up evidence like a sponge.
Learn how auditees hide nonconformities in plain view, based on predicted auditor behavior.
Never again have your audit findings challenged because of weak evidence.
Speaker Bio: Christopher Paris is a former Chemical Process Engineer, and has worked with ISO 9001 systems since 1988.  In 1999, he founded Oxebridge Quality Resources, an ISO 9001 and AS9100 consulting firm whose clients include SpaceX, Lufthansa, L3 Communications, and
200 small and medium sized organizations. He was a member of the US TAG to TC 176,
and is an international speaker on the subject of quality and ISO 9001, primarily advocating
for the point of view of standards users.  Click Here for more on Christopher Paris bio.