“QMS CURRENT REGULATORY REQUIREMENTS- Part 2”

When:  May 28, 2025 from 04:00 PM to 07:00 PM (ET)
Associated with  Medical Device Division

ASQ New England Discussion Group (NEDG) Presents by request:  

 VIRTUAL WEBINAR: 

“QMS CURRENT REGULATORY REQUIREMENTS- Part 2 

 IS YOUR QMS MEETING CURRENT DESIGN AND SUPPLIER QUALITY EXPECTATIONS? 

TO BE CERTAIN YOU COMPLY WITH CURRENT REQUIREMENTS – JOIN THISHOW TO COMPLY” WEBINAR 

 

SESSION TOPICS:  

  • DESIGN CONTROLS  

DESIGN CONTROL CONTINUAL ROLE IN PRE- AND POST-MARKET  

SUPPLIER MANAGEMENT – FROM THE BEGINNING TO RELEASE AND BEYOND! 

IMPORTANCE OF EARLY INVOLVEMENT OF SUPPLIERS FOR SUCCESS 

 

AREAS TO BE COVERED:  

  • Understand the importance of design controls in device quality and why they are a quality system requirement    

  • Know the Quality System Regulation requirements for design controls and learn how its sections interact with one another and the rest of the quality system 

  • Understand the continual role design controls play in both premarket and post-market device development 

  • Provide insight into the importance of involving Quality from the beginning of the design project and how that improves the success of the product launch and post-market surveillance 

  • Utilizing the expertise of suppliers for success in design and manufacturing 

 SPEAKERS: 

Dennis Shay, Regulatory Affairs Director, Best Buy Health 

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Text BoxJames Shore, Principal, Quality Lean Solutions 

 

 Program Log-on/Access Information:

Two -three days prior to the seminar, you will receive the log-on information for this programPLEASE 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, 2025Should you NOT receive these details, please check your SPAM folderIf 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 James Shore. 

 

Program Charge: 

  • Registration Fee $ 49.00 

Event Refund Policy:  

Unfortunately, we cannot offer refunds for cancellations made within one week of this eventRefunds requested prior to one week will be honored. However, the sign-on fees from Member Planet will be chargedSubstitute or replacement people are always permitted. Please get in touch with 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 attendees. 

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 tohttps://mp.gg/qqrwrp7  

or scan QR Code: 

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Send your questions to:  

Co-Program Chair, Dennis Shay, - dpshay@gmail.com    

Co-Program Chair, James Shore – james@qualityleansolutions.com  

 

 

*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 knowALTERNATIVELY, IF YOU WOULD LIKE TO PRESENT A TOPIC, LET US KNOWOur 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.    

 

Location

Online Instructions:
Url: https://mp.gg/qqrwrp7
Login: See above