Navigating instrument compliance, validation and calibration requirements isn’t easy. Our webinars are designed to help you make sense of the challenges you will encounter, led by experts who know what to expect. Register for upcoming webinars or view our past webinars on demand below.
Demystifying Analytical Validation While Onboarding NGS Tests
Next-generation sequencing (NGS) is quickly becoming the go-to tool for testing labs looking to bring on additional tests requiring smaller tissue samples, reduced time to results, and increased efficiencies and profitability. While these labs are faced with inherent challenges—such as staffing resources and competencies, testing volumes, and reimbursement—more and more are deciding that insourcing commercially available NGS tests is the way to go for the greatest return on investment. However, adapting to variability in the compliance environment, applying requirements to molecular assays, and knowing the documentation needed can pose additional risk.
In this webinar, you will hear about the importance of analytical validation (AV) in the process validation workflow when introducing NGS-based testing. An AV specialist will summarize the College of American Pathologists (CAP) checklist for NGS tests, the New York State Department of Health (NYSDOH) guidelines, and the importance of demonstrating utility as relating to the AV consulting services provided by Thermo Fisher Scientific. The webinar will cover the importance of using the CAP checklist and NYSDOH guidelines to aid in the launch of new molecular tests.
- Recognize the requirements outlined in the CAP checklist when onboarding new NGS tests
- Discuss how Thermo Fisher Scientific aligns their AV consulting services to the CAP and NYSDOH guidelines
- Discuss the challenges faced by molecular testing labs when bringing new tests online
About the speakers:
Sr. Project Manager, Analytical Validation (AV) Consulting Services, Thermo Fisher Scientific
Geoffrey Bien is the senior project manager at Thermo Fisher Scientific for AV consulting services for Ion Torrent Oncomine products. In this role, Geoffrey consults with molecular testing labs on the AV process when onboarding new NGS assays. Geoffrey started his career in molecular diagnostics at Clarient (GE Healthcare/NeoGenomics) in Aliso Viejo, California, where he was responsible for the development and validation of allele-specific PCR and Sanger sequencing assays. In 2013, he joined Thermo Fisher Scientific and was part of the team that implemented NGS at the company's lab in West Sacramento, California. After a brief stint at an engineering firm, Geoffrey rejoined Thermo Fisher Scientific in his current role, where he has helped develop the current AV consulting services for NGS.
Leah Ames, MS, MLS (ASCP) SCYM
Coordinator, Molecular Biology Department, Alverno Laboratories
Leah Ames is a coordinator for the molecular biology department, and the lead medical laboratory scientist responsible for implementing NGS, at Alverno Laboratories in Hammond, Indiana. She has spent the last 13 years working in their molecular laboratory bringing new tests online, including the lab's recently implemented Ion Torrent Oncomine Myeloid Panel workflow. She holds a specialist certification in flow cytometry from the American Society for Clinical Pathology (ASCP) and is an adjunct professor in the laboratory science programs of multiple universities, focusing on professional collaboration, patient safety, and improving diagnostics in health care.
Instrument Compliance for a Quality System: A Candid Conversation About IQ/OQ/PQ
For laboratories that operate within a quality management system, compliance with global standards such as ISO 9001, ISO 13485, ISO 17025, ISO 15189, GxP, and other country-specific regulations require documented verification that laboratory instruments are installed and operating according to the manufacturer’s specifications for the design's intended use. Performing these tests on your own can be complex, time-consuming, costly, and challenging to complete. A properly planned and scoped compliance initiative and process validation engagement is more flexible than a reactive engagement due to non-compliance. By providing peace of mind through testing and documentation to help ensure that instruments and equipment are working appropriately and producing high-quality data, qualifications are important to every laboratory, even those not operating in a regulated environment.
In this webinar, you’ll hear from compliance specialists at Thermo Fisher Scientific on the importance of complete qualification protocols and documentation, their value in process validation, and the importance of maintaining a quality system.
- Learn why qualifications (IQ/OQ/PQ) are important and when they are required
- Learn how instrument and equipment qualifications fit into process validation
- Learn what is included in qualifications from Thermo Fisher Scientific
About the speakers:
Product Manager, Compliance and Professional Services, Thermo Fisher Scientific
Randall Albright is the global product manager for compliance and professional services at Thermo Fisher Scientific. In this role, he is responsible for the business segments of the qualifications, computer system validation, and analytical validation services for the Applied Biosystems, Invitrogen, and Ion Torrent instruments. Randall's prior background includes several years as a US FDA investigator, specializing in medical device and imports. Randall brings over 25 years of industry experience in biotechnology and engineering.
Technical Applications Manager, Cold Storage Division, Thermo Fisher Scientific
Dean Rainbolt is the Technical Applications Manager for the Cold Storage Division at Thermo Fisher Scientific. With over 28 years of Pharmaceutical experience, Dean spent over 21 of those years supporting multiple business units such as Development Stability, Corporate Reference Standards, Analytical Testing labs as well as the Bio-Assay group in regard to Asset Management, Validation and Qualification services. He was the primary audit contact in the above areas as well as an auditor for other internal business units and is considered a process validation expert among his peers.