Sponsored Webcast: FDA QMSR: What do the Proposed Changes Mean for Industry?

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Virtual Programs Virtual Programs
Wednesday, 03 August 2022 (10:00 AM) - Wednesday, 03 August 2022 (11:00 AM) Eastern Time (US & Canada)

NAMSA and the Regulatory Affairs Professional Society (RAPS) will hold this webcast to bring awareness to the U.S. Food and Drug Administration’s (FDA) Quality System Regulation (QSR) proposed changes and what these may mean for the medical device industry and MedTech manufacturers as a whole.

During this online event, NAMSA’s quality experts will review the FDA’s proposed changes to Quality System Regulation (21 CFR part 820) which is now referred to as Quality Management System Regulation (QMSR). Specifically, we will review the history of quality systems, look at the changes to quality regulations and discuss the FDA’s intent to align with the ISO 13485 standard. Speakers will also provide a focused look at what the proposed QMSR changes mean for device manufacturers’ quality systems, including organizations that adhere to the current FDA QSR standard.

Discussion will include:

  • An overview of the proposed QMSR structure: why, what, when?
  • QMSR & ISO 13485 Comparison: a deeper dive to highlight similarities and differences and their impacts to the industry
  • Next steps as an industry


Learning Objectices

  • Overview of the proposed QMSR structure: why, what, when?
  • QMSR & ISO 13485 Comparison: a deeper dive to highlight similarities and differences, and their impact to the industry
  • Things we still don't know and next steps?

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.


Who Should Attend

The focus will be on quality and regulatory professionals from medical device organizations with a presence or interest in the US market – although all device manufacturers will find value in this webinar.


Registration Fees & Deadlines

Member $0 | Nonmember $0


Instructors:

Lisa Schwartz

Lisa Schwartz
NAMSA

Lisa Schwartz joined NAMSA in 2021 as a Principal Quality Consultant and is passionate about helping manufacturers improve QMS to ensure compliance to quality standards and regulatory requirements. Lisa has more than 20 years of experience in the medical device industry, including developing, implementing and managing quality management systems (QMS) for medical devices startups to midsize and global companies. While in industry, she has held various individual contributor and quality leadership roles in quality assurance supporting or overseeing QMS compliance, design, manufacturing, quality engineering, supplier quality and auditing. Other medical device industry experience involves a wide range of products including: implantable devices, single use products and drug coated devices. She also has experience working for a notified body as a lead auditor, 510(k) reviewer and project manager.

LINDA MUMMAH-SCHENDEL

Linda Mummah-Schendel
NAMSA

Linda Mummah-Schendel has more than 30 years of regulatory experience in the medical device industry. She has developed, implemented and trained on new and re-engineered quality systems, including projects related to continuous improvement, product non-conformance, CAPA systems and root cause analyses. She has led multiple project management and development activities for a wide variety of medical devices and combination drug/devices, including in vitro diagnostic (IVD) and biopharmaceutical products. An expert in GMP regulation and ISO 13485 quality system requirements, Mummah-Schendel also has extensive knowledge and experience surrounding IDE and PMA submissions.

Rich Granquist

Rich Granquist
NAMSA

Rich Granquist has 16 years of experience in the medical device industry and has spent extensive time working with both start up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management.

Rich Granquist has 16 years of experience in the medical device industry and has spent extensive time working with both start up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management.

Granquist started in the medical device industry as a microbiologist focusing on aseptic technique and terminal sterilization at Cook Medical. During his eight year career at Cook, he expanded his responsibilities to include coordination of pre-clinical testing including, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices. Before leaving Cook, Rich spent two years as a quality engineer performing complaint investigations, root cause investigation and product development focusing on aortic intervention vascular devices. In 2014, Rich joined NAMSA as a quality systems consultant and has now been with the company for eight years. In 16 years in the industry, he has participated in numerous AAMI ISO standards committees and currently sits on the committees for ISO 14971, ISO 13485, and ISO 15223.


Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the webcast.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org

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