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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand
recording from October 2020.
2020 has been a year of challenges, but it
has also provided experiences from which we can reflect and learn. In the
diagnostic world, manufacturers have had to develop new devices at breakneck
speak and get them to market to help battle a public health pandemic. As our
knowledge of COVID-19 matures and as we understand more about how tests can
help at difference points in the care pathway, manufacturers are now looking to
repurpose emergency use applications into global registrations.
COVID-19 has put the design and development process into a pressure cooker, it
is still necessary to have a well thought-out plan for moving your IVD along a
development pathway to succeed for emergency use applications as well as for
traditional global submissions. Whether you are developing SARS-CoV-2 assays or
are just interested how to efficiently build your global submissions, this webcast
aims to share some of those best practices using SARS-CoV-2 as a case study.
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.
Upon the conclusion
of the program you will:
Understand how to efficiently compile IVD
submission for global submissions
Understand how to develop submissions in tandem
with the design of the product
Have learned tips and common pit falls to avoid
when generating global IVD submissions
IVD Regulatory professionals
IVD Design teams
Developers of SARS-CoV-2 assays
Christie Hughes, IVD consultant, Qserve Group
Christie Hughes has
over 20 years’ experience with thorough knowledge of the IVD sector in quality,
regulatory, auditing and training. She has versatile knowledge of quality
assurance and regulatory affairs with hands on experience and expertise in
quality management systems, regulatory affairs, project management and clinical
affairs. Between 1996 and 2016, she held roles including QA Manager, Quality
& Compliance Manager, QA Director, Product Manager for microRNA tests, and
Senior Manager Regulatory Affairs at IVD multinationals Luminex and Thermo
Fisher Scientific. Since 2017, Christie has run her own consulting firm,
Integrys Consulting, where she has worked on several projects in the QA/RA IVD
area for both Qserve and her own firm.
Christie has a
master’s in public health degree in epidemiology and a bachelor’s degree in
biology/medical technology, is a certified medical technologist (medical
laboratory scientist) through the American Society for Clinical Pathology
(ASCP) and is a certified quality auditor through the American Society for
Lorry Weaver, US principal consultant,
regulatory affairs, Qserve Group
Lorry Weaver has
over 30 years of experience in the medical industry, working in large
multi-national corporations, mid-sized companies, clinical laboratories, and
the consulting business. In addition to her domestic roles, she has held global
responsibilities in Europe, Canada, Japan and China. In this time, Lorry has developed regulatory
and quality expertise spanning a broad range of product areas, including Class
II cardiovascular and renal devices, Class III cardiovascular implants, in
vitro diagnostics ranging from standard microbe identification and
antimicrobial susceptibility panels to genetic sequencing of bacteria, viruses,
and tumor tissue as companion diagnostic (CDx) assays using next-generation
sequencing (NGS). She has thorough knowledge of developing US regulatory
strategies, engaging with FDA through pre-submissions (Q-subs) to partner with
FDA and the manufacturer in developing novel regulatory pathways, writing IDEs,
510(k)s, and PMAs.
Lorry has a
bachelor’s in microbiology with a minor in chemistry from Northern Arizona
University and an MBA with emphasis in marketing from CSU-Sacramento. She is
also a licensed Medical Technologist and Clinical Laboratory Scientist by the
American Society for Clinical Pathology (ASCP), the National Credentialing
Agency for Laboratory Personnel, Inc. (NCA), and the State of California.
Sue Spencer, head of IVD, Qserve Group
Sue Spencer has over
30 years’ experience in the Medical Device and IVD industries where she has
held positions in R&D, Manufacturing and Quality Assurance. She has worked
in the notified body arena since the initial introduction of the Medical
Devices and IVD Directives and is now involved with the development of the new
regulations. She has over 14 years’ experience working for several notified
bodies; where she chaired the IVD subgroup of NBMED coordinating the notified
body responses to the IVDR and participated in the Commission IVD Technical
Sue is presently a
consultant with Qserve Group where she leads an experienced team to support
manufacturers develop strategies, prepare technical documentation, and
implement the requirements of the IVDR, FDA and other regions.