Medical Device Division

 View Only

Reminder: in person event - Risk Based Supplier Quality Management - May 23, 2024, 3:30-8:00 PM

By Lisa Grosskopf posted 05/10/24 09:56 AM

  

ASQ New England Discussion Group (NEDG) Presents:

Risk Based Supplier Quality Management

May 23, 2024  3:30-8:00 PM

HOW WELL IS RISK CONTROLLED IN YOUR SUPPLIER QUALITY MANGEMENT PROCESS?  FIND OUT FROM OUR EXPERT PRESENTERS HOW TO REDUCE SUPPLIER RISK.

Does your company….

Understand if your existing supplier quality practices are functional and compliant?  

Understand how to mitigate quality risk throughout your supply chain?

Come learn …

How to make your Supplier Quality Management Process risk controlled, efficient, and meeting regulatory requirements.

TOPICS TO BE COVERED:                                                                                                                                                         

Supplier Management Introduction/Overview                                                                                                              Supplier Initiation, Qualification, and Inputs During Design                                                                                                                     Supplier Management Practices- NCMR’s, SCARS, “Use as Is”, Supplier Replacement                                                  Risk in Supplier Selection, Supplier Qualification/Requalification, How to handle “off the shelf                            components”,  Supplier Auditing  

link to registration    

PRESENTERS:          

Diane Shay, Vice President Quality, Interative Scopes. Seasoned professional with extensive experience in medical device, and biopharmaceutical experience in quality management/operations, quality assurance, quality control, operations, and product development with a demonstrated commitment to quality and compliance excellence. Diane has worked for larger companies such as Haemonetics, C.R. Bard, Medtronic and Millipore.  She has spent the last 15 years in combination device / drug products working for smaller startup companies such as scPharmaceuticals and EyePoint Pharmaceuticals.

James Shore, Chief Quality Officer, Quality Lean Solutions. James “Gunny” Shore is the chief quality officer at Quality Lean Solutions. He offers over 30 years of quality and supplier management experience working Boston Scientific, Aspect Medical, ACMI, Brooks Automation, and Raytheon). Shore’s professional certifications include ASQ Certified Six Sigma Black Belt, ASQ Certified Quality Manager/Operations Excellence, Certified Quality Auditor, and Certified Mechanical Inspector, as well as ASQ Senior Member. Co-author of the book entitled “Proactive Supplier Quality Management in the Medical Device Industry,” which is published by Quality Press.

Peter Karon, Sr. Supplier Quality Engineer, NeedleTech Products, Inc., has been working for a mid-sized medical device contract manufacturing company, NeedleTech Products, Inc. since 2008.  Peter leads supplier quality to enable a complex supply chain with a large number of varied materials and complex components to meet regulatory and customer requirements.  His role as the Supplier Quality Engineer includes supplier auditing, supplier risk management and supplier performance trending/analysis.    In addition to BA and Masters degree, Peter holds ASQ certifications as a Certified Supplier Quality Professional (CSQP), Certified Medical Device Auditor (CMDA) and Certified Six Sigma Green Belt (CSSGB). 

Karen Brozowski, Quality Consultant, has over 35 years of medical device quality and regulatory affairs experience in the Medical Device industry. She has expertise in FDA and world-wide submissions, third party inspections, process validation, sterilization, and all phases of quality systems management. She is  Regulatory Affairs Certified (RAC) and holds ASQ Certifications-- Certified Medical Device Auditor and Certified Supplier Quality Professional.  She holds a BS Degree from Worcester Polytechnic Institute and a MA Degree from Anna Maria College.

Cost

• Registration Fee after May 1st : $199.00

Food/Beverage:

Refreshments throughout and dinner provided

Event Refund Policy

We unfortunately cannot offer refunds for cancellations made within 1 week of this event.  Refunds requested prior to one week, will be honored, however, the sign-on fees from Member Planet, will be charged.  The NEDG does offer full credit towards future events. Substitute or replacement persons are always permitted. Please contact the program chair listed if a change is to be made to ensure we have the most up-to-date information on the event’s attendee.

Location:

Waltham Woods Conference Center

860 Winter Street

Waltham, MA 02451

To Register: go to https://app.memberplanet.com/#/event/asqbiomedicaldivisioncommittee/asqnedgpresentsriskbasedsupplierqualitymanagement                        

Program Chair:  Karen A. Brozowski,  774-249-5668, karenbrozowski@cs.com

0 comments
4 views

Permalink