Date/TimeAugust 3, 2022
NAMSA and the Regulatory Affairs Professional Society (RAPS) present this webinar 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 webinar, 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
Lisa SchwartzPrincipal Quality System Consultant
Lisa Schwartz joined NAMSA in 2021 as a Principal Quality Consultant and is passionate about helping Clients improve their Quality Management System (QMS) to ensure compliance to quality standards and regulatory requirements. Lisa has over 20 years’ experience in the medical device industry, including developing, implementing and managing QMS for medical devices start-ups to midsize and global companies. While in industry, she has held various individual contributor and quality leadership roles in Quality Assurance (QA) 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.
Rich GranquistSenior Quality System Consultant
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 started in the medical device industry as a Microbiologist focusing on aseptic technique and terminal sterilization at Cook Medical. During his 8 -year career at Cook, he expanded his responsibilities to include coordination of preclinical testing including, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices. Before leaving Cook, Rich spent two (2) 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. Over his 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.
Linda Mummah-SchendelPrincipal Quality System Consultant
Linda Mummah-Schendel has over 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 IVD and biopharmaceutical products. An expert in GMP regulation and ISO 13485 Quality System requirements, Ms. Mummah-Schendel also has extensive knowledge and experience surrounding IDE and PMA submissions.