ASQ New England Discussion Group (NEDG) Presents
by request:
VIRTUAL WEBINAR:
“QMS CURRENT REGULATORY REQUIREMENTS- Part 1” *
April 29, 2025, 3:00-7:00 PM ET
IS YOUR QMS MEETING CURRENT REGULATORY EXPECTATIONS?
TO BE CERTAIN YOU COMPLY WITH CURRENT REQUIREMENTS – JOIN FOR THIS “HOW TO COMPLY” WEBINAR
SESSION TOPICS:
· QMS PLANNING AND STRUCTURE
· QUALITY MANUAL
· INTERNAL AUDITS
AREAS TO BE COVERED:
· Current practices for Quality Planning, QMS Structure, Quality Manual, Internal Audits
· Compliance “how to” with direction from a practitioner/leader
· Escape the pitfalls when implementing or improving your systems
· Come learn the required changes and obtain the knowledge to update your QMS to meet current regulatory expectations
SPEAKERS:
Diane Shay, Vice President of Quality, Iterative Scopes
Diane Shay is currently Vice President of Quality at Iterative Scopes. Diane is a 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. Has managed the oversight and execution of quality and regulatory compliance functions across all GxP processes through clinical development to global commercialization. Responsibilities include development and implementation of policies, procedures and protocols for compliance with GxP activities as well as establishing a quality organization and software solutions in order to meet regulatory compliance requirements. 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, Principal, Quality Lean Solutions
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 in 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. TBD.
Karen Brozowski, Quality Consultant
Karen Brozowski has over 30 years of medical device quality and regulatory affairs experience in the Medical Device industry in various capacities. She has expertise in FDA and world-wide submissions, third party inspections, process validation, and all phases of quality systems management. She has experience with FDA/ISO audits and supplier audits within the USA as well as at many locations internationally. Karen has worked in the field of medical devices throughout most of her career, with resident positions in the United States, United Kingdom, Northern Ireland, and Asia. Her work history includes positions at Corning Medical and Scientific, Teleflex Inc., Medtronic Inc., Arteriocyte Medical Systems, and NeedleTech Products, Inc. Product experience includes Class II and III medical devices, and IVD’s. She is a Regulatory Affairs Certified (RAC), ASQ Biomedical Auditor Certified, and an ASQ Certified Supplier Quality Professional. She holds a BS Degree and a MA Degree.
*Be an Event Influencer:
WE ARE URGING YOU TO SUPPLY ANY QMS TOPIC SUGGESTIONS, that you would like presented during our follow-on Sessions, so please let us know. ALTERNATIVELY, IF YOU WOULD LIKE TO PRESENT A TOPIC, LET US KNOW. Our purpose under the ASQ Umbrella is to meet the educational needs of our attendees and we take this very seriously.
To request other Quality System topics or to present in the multipart program series, contact Dennis Shay at dpshay@gmail.com.
Program Log-on/Access Information:
Two -three days prior to the seminar, you will receive the log-on information for this program. PLEASE MAKE SURE THAT THE EMAIL ADDRESS YOU USE FOR REGISTRATION IS THE CONTACT EMAIL ADDRESS DESIRED FOR YOUR REGISTRATION LINK. This email address will be used to provide your log in details to access this seminar starting at 4:00 PM on April 29, 2025. Should you NOT receive these details, please check your SPAM folder. If you do not receive this link and it is not in your SPAM folder, please contact us using the links below for Dennis Shay or Karen Brozowski.
Program Charge:
· Registration Fee $ 49.00
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. Substitute or replacement people 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.
Attendance Certificate Credit:
This will be supplied via email after the webinar with attendance confirmed for the event and released slides.
0.5 RU
Registration Information:
go to: https://mp.gg/dj9vewls
or scan QR Code: 
Send your questions to:
Program Chair, Dennis Shay, - dpshay@gmail.com
Program Assistant, Karen Brozowski - karenbrozowski@cs.com (774) 249-5668.