Although the covid pandemic mitigations have been challenging, they have resulted in a perspective adjustment at MSACL that has revealed an exciting opportunity to extend the
knowledge base of the MSACL community even further into the research and clinical space ... consistent online content.
Under this new paradigm of operation, we are offering a platform of engagement to provide not only classical SCIENTIFIC CONTENT, but also to extend
the best of the MSACL NETWORKING effects -- such as those found during Booth and Poster Tours, and the Meet-a-Mentor program -- into the virtual space. SHORT COURSES are also a part of the Connect ecosystem.
Wed
Feb
19, 2025
Los Angeles : 10:00 AM - 11:00 AM
NEW YORK:
Feb 19 • 01:00 PM - 02:00 PM
LONDON:
Feb 19 • 06:00 PM - 07:00 PM
PARIS:
Feb 19 • 07:00 PM - 08:00 PM
INDIA:
Feb 19 • 11:30 PM - 12:30 AM
CHINA:
Feb 20 • 02:00 AM - 03:00 AM
SYDNEY:
Feb 20 • 05:00 AM - 06:00 AM
Seminar
There is no cost to register for this activity.
Moderator(s):
Jacqueline Hubbard, PhD, DABCC Beth Israel Deaconess Medical Center, Harvard Medical School
Managing LDT Materials with MS Access - QA and FDA Compliance for the 21st Century
Dawn Francisco
UC San Diego Health
Dawn Francisco is currently the lead clinical laboratory scientist at the University of California San Diego Health clinical toxicology lab. She received her bachelor's degree in biochemistry in California State University San Marcos and completed her clinical lab scientist training at the University of California Irvine Medical Center.
This presentation will review the UCSD CALM Toxicology Laboratory experience using a home-brew MS Access database for record keeping and tracking of mass spectrometry LDT reagents, chemicals, mobile phases, primary standards, calibrators, etc. Using the system delivered hours of time saved, easier investigation of LDT materials as a possible source of complaints, non-conforming events, QC or PT problems, and no-stress review of documentation during inspections. SOP and database templates for the system will be available for download from the MSACL-CAC webpage after the webinar.
Thu
Feb
20, 2025
Los Angeles : 07:30 AM - 10:30 AM
NEW YORK:
Feb 20 • 10:30 AM - 01:30 PM
LONDON:
Feb 20 • 03:30 PM - 06:30 PM
PARIS:
Feb 20 • 04:30 PM - 07:30 PM
INDIA:
Feb 20 • 09:00 PM - 12:00 AM
CHINA:
Feb 20 • 11:30 PM - 02:30 AM
SYDNEY:
Feb 21 • 02:30 AM - 05:30 AM
Workshop
Quality Control
There is no cost to register for this activity.
Mastering ISO 15189: A Comprehensive Guide for Metabolomic Labs
Sindhu Nair, Ph.D
Q Boost Inc.
Sindhu Nair is a seasoned Quality Consultant and CEO of Q Boost Inc., with extensive experience in quality management and software development. She has successfully implemented ISO and CLIA standards across various labs and is an active contributor to the development of ISO 15189 standards. Sindhu also performs audits for ISO 17025, ISO 9001, ISO 13485, and ISO 15189 standards.
In her role at Q Boost Inc., Sindhu provides quality consultation services to research labs and start-ups, performs ISO audits, and develops quality-compliant e-QMS systems. She is an active member of various professional organizations, including the Metabolomics Quality Assurance and Quality Control Consortium (mQACC), the Standards Council of Canada (SCC), and the Canadian Standards Association (CSA).
Sindhu is recognized for her leadership, problem-solving skills, and passion for quality system development, consistently enhancing laboratory standards and practices.
Yamilé López Hernández
Clinical Metabolomics Laboratory, Universidad Autónoma de Zacatecas
Dr. Yamilé López Hernández (Ph.D in Health Sciences) is the Technical Director of the Clinical Metabolomics Laboratory at the Universidad Autónoma de Zacatecas, Mexico and a Research Associate at Wishart´s lab (University of Alberta, Edmonton, Canada). As head of the Metabolomics and Proteomics Facility at the Autonomous University of Zacatecas, she has built one of the region's premier laboratories for biomarker discovery, which uses untargeted and targeted metabolomics techniques to identify critical biomarkers for diseases such as COVID-19, diabetes, and cancer. By building this facility from the ground up, Dr. López Hernández has positioned her lab as a leading institution in Mexico for biomarker research, supporting both national and international collaborations. Her contributions are groundbreaking for Latin America, where access to cutting-edge technologies like mass spectrometry has historically been limited. She is a member of the Board of Directors of the North American Metabolomics Society (MANA) and member of the Metabolomics Society and the Latin American Metabolite Profiling Society.
By the end of this 3-hour workshop, participants will be able to:
Understand ISO 15189 Requirements: Clearly articulate the key requirements and standards of ISO 15189 specific to metabolomic labs, including documentation, quality control, and management responsibilities.
Implement Best Practices: Apply best practices and strategies for establishing a quality management system (QMS) that meets ISO 15189 standards, including risk management, external and internal quality control, corrective actions, and continual improvement processes.
Prepare for Certification: Develop a step-by-step plan to prepare their metabolomic lab for ISO 15189 certification, including conducting internal audits, addressing non-conformities, and engaging with accrediting bodies.
Utilize Tools and Resources: Identify and utilize tools, resources, and software solutions that can aid in meeting ISO 15189 requirements, enhancing lab efficiency, and ensuring compliance.
Troubleshoot Common Challenges: Recognize and troubleshoot common challenges and obstacles faced during the ISO 15189 certification process, with special emphasis on developing a proper method validation protocol and implementing an effective training and competency program. Gain practical guidelines and solutions to overcome these issues.
Thu
Mar
06, 2025
Los Angeles : 11:00 AM - 12:00 PM
NEW YORK:
Mar 06 • 02:00 PM - 03:00 PM
LONDON:
Mar 06 • 07:00 PM - 08:00 PM
PARIS:
Mar 06 • 08:00 PM - 09:00 PM
INDIA:
Mar 07 • 12:30 AM - 01:30 AM
CHINA:
Mar 07 • 03:00 AM - 04:00 AM
SYDNEY:
Mar 07 • 06:00 AM - 07:00 AM
Seminar
There is no cost to register for this activity.
Moderator(s):
Jacqueline Hubbard, PhD, DABCC Beth Israel Deaconess Medical Center, Harvard Medical School
What You Need To Know Now To Comply with FDA Labeling Requirements for LDT’s
Jessica Miley
UTAK Laboratories
Jessica Miley is the Quality Assurance and Regulatory Affairs Lead at UTAK Laboratories, Inc. She has been an integral part of the Regulatory team at UTAK since 2021 and played a key role in spearheading the implementation of Unique Device Identification (UDI) in product labeling, ensuring alignment with FDA labeling standards. As the designated Management Representative and a certified ISO 13485 lead auditor, she is dedicated to establishing and enforcing adherence to strict quality and regulatory standards within the organization.
Andrew Hartmann
UTAK Laboratories
Andrew Hartmann is the Business Development Manager at UTAK Laboratories, Inc., where he has spent the past decade spearheading initiatives in regulatory compliance and business growth. Formerly UTAK’s Regulatory Manager, Andrew served as the company’s Management Representative, overseeing all aspects of FDA labeling requirements and ensuring the organization maintained strict compliance standards. He is also a certified ISO 13485 Lead Auditor, bringing a broad understanding of quality systems to his role.
Are you confident your lab’s labeling processes are fully FDA compliant? With the FDA now enforcing laboratory-developed tests (LDTs) under the same rigorous standards as other IVDs, many labs are struggling to keep up. Non-compliance can lead to costly fines, failed audits, or even product recalls—mistakes no lab can afford. This webinar is your chance to stay ahead of the curve.
Join industry experts as they break down the most confusing and challenging aspects of FDA labeling requirements, specifically for laboratory-developed quality control (QC) materials. From deciphering regulatory jargon to creating airtight labeling procedures, this webinar will arm you with the tools and knowledge to eliminate compliance risks, streamline operations, and protect your lab’s reputation.
What you will get out of it:
- Clarity on FDA Requirements: Understand the critical aspects of FDA labeling compliance for laboratory-developed tests and QC materials.
- Actionable Guidance: Gain practical steps to implement a compliant labeling process tailored to your lab’s needs.
- Expert Insights: Learn from seasoned regulatory professionals with firsthand experience in FDA labeling and quality assurance.
- Avoid Costly Mistakes: Discover common labeling pitfalls and how to avoid them to protect your lab’s reputation and bottom line.
- Confidence in Compliance: Leave equipped with the knowledge and tools to ensure your labeling process meets FDA standards.
- Topics to include: How to comply with requirements of 21 CFR pts. 801 & 809, label vs labeling, UDI, assigning claims and stability, and tips and tricks from our over 50 years in medical device labeling experience.