ASQ New England Discussion Group (NEDG) Presents
by request:
VIRTUAL WEBINAR:
“READINESS RONDEZVOUS” –
FDA’S QSR UPDATE TO QMSR
September 24, 2024, 4:00-7:00 PM ET
FDA SPEAKER: CAPTAIN KIMBERLY LEWANDOWSKI-WALKER
HOW WELL ARE YOU PREPARED FOR COMPLIANCE WITH THE FDA’S ADOPTION OF ISO 13485:2016?
TO BE CERTAIN YOU COMPLY -- JOIN US TO HEAR FROM THE REGULATOR, THE PRACTITIONER, AND THE AUDITOR!
Is your company knowledgeable regarding the changes/additions required by FDA for the incorporation of ISO 13485 in CFR 820?
Come learn the required changes to update your FDA based quality system compliance to meet the new regulatory requirement.
Obtain knowledge directly from the FDA supplemented by our knowledgeable speakers
Get ready! Compliance is required by February 2, 2026
TOPICS TO BE COVERED:
• Overview of updates to the regulation
• Scope, Definitions and changes to previous exemptions
• Control of Records and Complaints
• Requirements for QMS, which includes Design Process and Records
• Control of Production and Service, which includes Device Labeling and Packaging
• Compliance “how to” and direction from a practitioner
• Auditor compliance requirements
SPEAKERS:
CAPT Kimberly Lewandowski-Walker, Senior Regulatory Officer, Center for Devices and Radiological Health, U.S. Food and Drug Administration
CAPT Kimberly Lewandowski-Walker, Senior Regulatory Officer with the U.S. Food and Drug Administration, Office of Product Evaluation and Quality, Center for Devices and Radiological Health. I have a Doctor of Optometry Degree from Indiana University, a Master of Science in Human Services from Capella University, and a Bachelor of Science in Biology from Indiana University. I currently work on the Medical Device Single Audit Program (MDSAP) team. I have been a course developer and instructor for various FDA medical device training courses and the developer of the Medical Device Single Audit Program training series for the third-party auditors and regulatory authority assessors. Additionally, I am an ASQ Certified Biomedical Auditor and have completed the ISO 13485 Lead Auditor course and the ISO 17021 course.
Teresa Cherry, Vice President Quality Assurance and Regulatory Affairs, Xenix Medical
Teresa Cherry has worked as a quality professional for over 30 years, in the Medical Device and Defense Industries. She has a Bachelor’s Degree in Mechanical Engineering and a Master’s Degree in Engineering from the University of Central Florida. Currently she is the VP of Quality and Regulatory Affairs for Xenix Medical, a small medical device company who develops, manufactures and distributes implants and surgical instruments used in spine surgery. Since starting at Xenix Medical in 2021, they have become ISO 13485:2016 Certified and have updated their QMS for the new Final Rule of 21 CFR 820. She has worked in quality at both large organizations (such as Alcon and Lockheed Martin) and several small startups.
Teresa Cherry has served 12 years as a Member Leader with the Medical Device Division of the professional society, American Society for Quality (ASQ). She is also a member of the Regulatory Affairs Professional Society (RAPS) and holds several certifications through both organizations (ASQ CQA, ASQ CQE, ASQ CMDA and RAPS RAC Devices). She is also a Certified Lead Auditor for ISO 13485:2016 through Oriel Stat-A-Matrix and has presented various quality topics at several ASQ Conferences, including WCQI.
Timothy Barash – BSI Assessor (Retired)
Timothy Barash has over 40 years of experience in the medical device industry in a broad range of areas including quality assurance, regulatory affairs, auditing, manufacturing, and new product development. Tim retired from over 16 years with BSI as a Senior Lead Auditor and continued auditing with BSI as an External Resource until fully retiring in April 2024. He is a Senior Member of ASQ and the ASQ Medical Device Division, is an ASQ Certified Quality Engineer, and is an active participant on the board of the New England Discussion Group.
Program Date: SEPTEMBER 24, 2024
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 September 24, 2024. Should you NOT receive these details, please check your SPAM. If you do not receive this link and it is not in your SPAM, please contact us using the links below.
Program Charge:
• Early Bird Registration: $59.00 (ends August 30, 2024)
• Registration Fee on/after September 1st : $79.00
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 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.
To Register: go to http: https://app.memberplanet.com/#/event/asqbiomedicaldivisioncommittee/readinessrondezvousfdaqsrupdatetoqmsr
Send your questions to: Program Chair, James Shore, Quality Lean Solutions- James@qualityleansolutions.com, (508) 726-0574 or Karen Brozowski, Program, Assistant - karenbrozowski@cs.com.