Mastering Quality Management Systems: Ensuring Compliance with the New FDA LDT Rule
Learning Objectives:
- Explain the role of a quality management system in compliance with the FDA LDT rule
- Discuss how the FDA will approach LDT assay modifications
- Evaluate considerations for building an effective QMS
C.E. Credits: P.A.C.E.® CE | Florida CE
Summary
Promega is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E® Program.
Promega is also a premier partner of CE Broker, the official tracking system of the Florida Board of Clinical Laboratory Personnel.
Level of Instruction: Intermediate
Number of Contact Hours: 1
(For P,A.C.E credit, criteria must be completed within 6 months of registration.)
*It is the registrant's responsibility to verify the applicability of the offered credits to meet individual continuing education requirements.
In the evolving regulatory landscape for diagnostics, the FDA LDT rule emphasizes the necessity for robust quality management systems (QMS). Join Promega and McDermott for an informative webinar that explores the significance of these systems in developing IVD assays. McDermott will provide an overview of the FDA rule, its phases, and the critical role of a QMS in compliance. Promega will demonstrate how laboratory quality systems can leverage its ISO-certified quality framework to streamline FDA submissions. This webinar will equip you with considerations for building an effective QMS, facilitating regulatory compliance and enhancing the reliability of your IVD assays.
Speakers
Michael W Ryan
Partner
McDermott Will & Emery LLP
Mike advises manufacturers, healthcare providers, drug and technology developers, and investors on the legal, regulatory and reimbursement issues that arise during the development and commercialization of medical devices, clinical laboratory testing services, biological products and drugs. Mike helps innovative companies identify and navigate applicable FDA regulatory requirements for new technologies, particularlyin vitrodiagnostics, laboratory-developed tests, and digital health products. He also guides life sciences companies and laboratories by evaluating and implementing strategies to optimize coding, coverage and payment for novel technologies.
Throughout the life cycle of US Food and Drug Administration (FDA)-regulated medical devices, drugs and biological products, Michael provides clients, including global device companies, diagnostic test developers, with sound guidance on compliance issues. He is experienced in the review of promotional and marketing materials for FDA-regulated medical products.
Michael also counsels clinical laboratories on state and federal compliance issues, including those under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), state laboratory licensure laws, and billing and reimbursement rules.
Abigail Davis
Director, Quality Assurance
Promega
Abigail Davis, M.S., is a seasoned Quality and Regulatory professional with over 25 years of experience spanning life science products, medical devices, and drugs. As the Director of Quality Assurance at Promega Corporation, she leads strategic QA initiatives and ensures compliance with key regulations and standards.
In academia, Abigail serves as an adjunct professor at both Northwestern University and the University of Wisconsin-Madison. At Northwestern, she teaches in the Quality Assurance & Regulatory Science Master’s Program, focusing on Applied Quality & Regulatory Practices. At the University of Wisconsin-Madison, she instructs on GxP (Good Laboratory/Clinical/Manufacturing Practice) standards in the Applied Drug Development Master’s Program.
Abigail holds a Master of Science in Biotechnology from the University of Wisconsin-Madison and a Graduate Certificate in Regulatory and Quality Compliance from Purdue University.
Abigail's extensive industry and academic experience provide her with a grounded and comprehensive perspective on quality and regulatory compliance.