Testing with Confidence: Evaluation Protocols and Strategies for Compliance in an Evolving Regulatory Environment
April 29, 2025
Event Details
Discover the latest in laboratory and diagnostic innovation with a new half-day virtual event from CLSI. This unique training session features keynote and panelist discussions with prominent industry experts and regulatory authorities as well as applied learning labs and workshop discussions. Sessions cover foundational statistical techniques and testing protocols to quality system implementation essential and standards conformance. Discuss real world challenges, anticipated oversight, and how the new regulatory implications will affect your laboratory with those who are in it every day!
Secure Your Spot Today
Date: Tuesday, April 29, 2025
Time: 12:00 - 4:00 pm ET | 9:00 - 1:00 pm PT
Price: $550. Register by 15 March for early-bird discounted price: $350
Learning Objectives
• Examine changes within the regulatory environment• Review effective standards implementation, quality system, and evaluation protocol best practices
• Discuss foundational statistical techniques and workshop specific challenges in implementing protocols
P.A.C.E. Information
Earn up to 4.0 P.A.C.E.® credits for the virtual event.
Eva Temkin
Arnold & Porter
Keynote Presentation
The Changing Regulatory Environment: What it Means for LDTs, IVDs, and Diagnostic Innovation and Practice
12:00pm ET | Kickoff from Dr. Barb Jones, CLSI CEO
"Defining a Course in the Path of Ambiguity – Leveling Up to Stay Ahead"
12:15pm ET | Keynote Presentation featuring Eva Temkin, Arnold & Porter
"The Changing Regulatory Environment: What it Means for LDTs, IVDs, and Diagnostic Innovation and Practice"
1:00pm ET | 10 Minute Break
1:10 - 2:00pm ET | (Applied) Learning Labs I
2:00pm ET | 10 Minute Break
2:10 - 3:00pm ET | (Applied) Learning Labs II
3:05 - 4:00pm ET | Panel Discussion
"Understanding the Implications for your Laboratory" featuring moderator Shannon Bennett (Mayo Clinic), Mario Wijker (RAQAIVD) and Mindy Nye (LabCorp)
Each session includes practical examples and applied learning, leveraging polling and interactive chat. All sessions include open Q&A in a “fireside chat” format.
Learners select one session from three different options for each hour:
Learning Lab I
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Session 1: "EP Framework: Validation Studies and Basic Data Evaluation"
Speaker: Michelle R. Campbell, MS, MLS
An insight into foundational frameworks for statistical techniques. -
Session 2: “Using Surrogate Samples for Performance Studies”
Speaker: Marvin Berman, PhD, CBT
A hierarchical approach for selecting surrogate samples for in vitro medical laboratory tests. -
Session 3: “Documentation and Quality System Implementation”
Speaker: Lucia M. Berte MLS(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE
Foundational principles for your laboratory’s Quality Management System
Learning Lab II
-
Session 1: “Establishing Acceptance Criteria”
Speaker: Kornelia Galior, PhD, DABCC
Defining total analytical error goals for quantitative medical laboratory test methods. Features a detailed preview of upcoming document CLSI EP46. -
Session 2: "Evaluating Precision Performance of Quantitative Measurement"
Speaker: Jesper Johansen, PhD, MS
Guidance for evaluating the precision performance of quantitative measurement procedures. -
Session 3: “Using CLSI Standards Recognized by the FDA”
Speaker: Victoria Petrides, MS
Specific applied knowledge for LDTs navigating regulatory procedures and/or adapting protocols for regulatory clearance.
Eva Temkin
Partner, Arnold & Porter
Keynote Speaker
Eva Temkin works with medical device, biotechnology, and pharmaceutical companies on a wide array of issues related to product development, approval, and marketing. Ms. Temkin has extensive experience with the unique issues facing biological products, including cell and gene therapies, in addition to a wide variety of drugs and devices. Drawing on nearly 20 years of practice, including almost a decade at the FDA, she works with clients to develop and execute regulatory, legislative, and litigation strategies. She also advises clients with respect to the Inflation Reduction Act and other new and evolving mandates affecting FDA-regulated products. Ms. Temkin is a frequent speaker and author on FDA regulatory issues and a contributor to multiple academic publications.
Mario Wijker
RAQAIVD
Event Co-Chair
Mario Wijker is a seasoned quality and regulatory professional with over 30 years of experience in the medical device and in-vitro diagnostics industry. In addition to roles in business development and strategic marketing, he has led global quality and regulatory organizations for 15 years and has developed and implemented quality systems in several companies. He is an expert in quality remediation program and translating quality and regulatory requirements into actionable deliverables for a corporation.
Shannon Bennett
Mayo Clinic
Panelist
Shannon Bennett works at the Mayo Clinic and has more than twenty years experience in the quality management field within the Department of Laboratory Medicine & Pathology. His current role is Director of Regulatory Affairs, focused on clinical laboratory test development and verification/validation, as well as interacting with a variety of regulatory agencies such as the New York State Department of Health and the FDA.
Dr. Barb Jones
CLSI CEO
Dr. Barb Jones was appointed Chief Executive Officer of CLSI on May 15, 2022. She is the third CEO in CLSI's 54-year history. Dr. Jones’ experience includes operations leadership, laboratory management, pharmaceutical and quality standards development, regulatory policy, and business development at both the national and international levels. Prior to her role as CLSI’s CEO, Barb was Senior Vice President, Scientific Operations and Regulatory Affairs at Vyant Bio in San Diego, California.
Mindy Nye
LabCorp
Event Co-Chair
Dr. Mindy Nye is a board-certified medical technologist (MT(ASCP)) and a diplomate of the American Board of Medical and Public Health Microbiology (D(ABMM)). Dr. Nye currently has the role of Vice President, Operations & Science Liaison in the Office of the Chief Scientific Officer at Labcorp. Dr. Nye was honored with the 2024 Luminary Award by the Healthcare Businesswomen’s Association.
Victoria Petrides, MS
Abbott Laboratories
Statistician and Quality Program Manager
Victoria Petrides, MS has more than 25 years of experience at Abbott Laboratories where she is a Statistician and Quality Program Manager in Abbott’s corporate Quality and Regulatory office. She is currently responsible for reviewing pre-market submissions between all of Abbott’s diagnostic divisions and the US FDA and for establishing and leading Abbott’s Laboratory Standards Intelligence Team.
Dr. Kornelia Galior
Grady Memorial Hospital
Director of Clinical Chemistry and Point of Care Testing
Dr. Kornelia Galior is a Director of Clinical Chemistry and Point of Care Testing at Grady Memorial Hospital and an Assistant Professor in the Department of Pathology and Laboratory Medicine at Emory Medical School in Atlanta, GA. She is involved in teaching pathology residents, medical laboratory scientists and endocrinology fellows. Dr. Galior interests in the field of laboratory medicine focus on preventing laboratory errors, applications of biological variations and defining quality metrics.
Dr. Marvin Berman, PhD
Abbott Laboratories
Associate Director, Reproductive/Endocrine Research System
Dr. Marvin Berman, PhD, Associate Director, Reproductive/Endocrine Research System has over 30 years of experience at Abbott in a variety of positions such as research, manufacturing, technical support, validation and scientific affairs. Dr. Berman plays an integral role in advancing immunoassay & clinical chemistry diagnostic assays with a multidisciplinary perspective from his various diverse positions.
Luci Berte
Ms. Berte has taught medical laboratories worldwide how to implement a Quality Management System for achieving accreditation, improving patient safety, and reducing the cost of poor quality. She also trains laboratorians how to write better documents and how to design more effective training and competence assessment programs. Ms. Berte has volunteered for CLSI for over 30 years and has served as chairholder and member of past and current QMS guidance document development and quality management committees.
Secure Your Spot Today
Date: Tuesday, April 29, 2025
Time: 12:00 - 4:00 pm ET | 9:00 - 1:00 pm PT
Price: $550. Register by 15 March for early-bird discounted price: $350
Become a Member
Join today to stay current on the latest regulation!
Members benefit from discounted and exclusive access to documents, education, and resources.
Learn more about about membership options.
Is there an early bird discount?
Yes, the early bird discount is $350 for those that register by 15 March 2025.
What payment methods are accepted?
We accept debit and credit cards including VISA, American Express, Mastercard, and Discover. You can also contact CustomerService@clsi.org if you wish to pay by check or wire transfer.
Is there a member discount?
Yes, education programs and discounts are an important part of CLSI membership! Members receive a-member exclusive price of $400 (versus $550 non-member price). Members are also eligible for the early-bird price of $350 if they register by 15 March 2025.
Where can I review my registration information?
You can review your registration information at My CLSI (hyper link) under “Order History.”
Can I change which sessions I am signed up for?
You will be able to select and change your sessions after you register for the event, on the event platform. Your registration entitles you to attend the opening and keynote sessions, two (of six) learning lab workshops, and the final panel session.
Are there breakout sessions? Where can I find information about them?
Yes, you can review the options for the breakout sessions within the agenda above. More detailed information and learning objectives for each session will be available on the event site. Registered attendees will receive an email and links to that site beginning at the end of February.
Will recordings, summaries, and or notes be available after the session?
Yes, registrants will have access to the on-demand recordings and a PDF version of the slides for all sessions attended. (It is important to register for the sessions you are interested in!) These recordings and documents will be available within one week of the event.
Is it possible to register a group?
Yes, group registrations are possible and can be beneficial for your laboratory. Please contact customerservice@clsi.org for assistance.
Where can I find information about claiming P.A.C.E. ® credit?
CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. Registered event participants can earn up to 4.0 P.A.C.E.® credits for the virtual event. You must complete the evaluation survey to earn the credits. Information will be available during the event and emailed to attendees.
How do I access the event on April 29th?
Registered attendees will receive email instructions with more information about how to access the event platform and how to select individual breakout sessions.