OCT 20, 2020

Thermo Fisher Scientific: Lab Compliance Solutions

Welcome to the Lab Compliance Solutions Virtual Event

This event will help expand the understanding of qualifications and validations as industry standard accepted processes supporting regulatory guidance and quality systems compliance in the laboratory environment. Throughout the event, a line-up of 8 leading compliance and industry professionals will share their personal expertise on topics ranging from:

Performing computer system validation, what is involved, how frequently it should be performed and the benefits it can have to help meet FDA regulations and quality standards
The importance of clinical labs following guidance provided by CAP for onboarding new NSG based clinical tests
How to mitigate the risk of potential non-compliance as you return to the lab or transition instrumentation to meet new demands with operational qualification and requalification services
The purpose for performing Analytical Validation as part of the larger process validation efforts for a laboratory workflow for clinical tests
The importance of performing instrument qualifications, their value as documentation in process validation, and the importance of maintaining a quality system

Speakers

Geoffrey Bien

Sr. Project Manager, Analytical Validation (AV) Consulting Services - Thermo Fisher Scientific
Leah Ames, MS, MLS (ASCP) SCYM

Coordinator, Molecular Biology Department - Alverno Laboratories
Randall Albright

Product Manager, Compliance and Professional Services, Thermo Fisher Scientific
Dean Rainbolt

Technical Applications Manager, Cold Storage Division, Thermo Fisher Scientific
Ilyn Lyzette Santos

Senior Project Manager, Professional Services, Thermo Fisher Scientific
Ryan S. Robetorye, M.D., Ph.D.

Molecular Diagnostics Laboratory - Department of Laboratory Medicine and Pathology Mayo Clinic in Arizona
Martin Wheeler

Regulatory Product Manager, Unity Lab Services part of Thermo Fisher Scientific
Julian Renpenning

Regional Marketing Manager EMEA, Thermo Fisher Scientific

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Agenda

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ondemand

OCT 20, 2020 10:15 AM PDT

Instrument Compliance for a Quality System: A Candid Conversation About IQ/OQ/PQ
Randall Albright, Dean Rainbolt
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.

Learning objectives:

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
SEE ABSTRACT HIDE ABSTRACT
Randall Albright
Product Manager, Compliance and Professional Services,...

Dean Rainbolt
Technical Applications Manager, Cold Storage Division,...
OCT 20, 2020 9:00 AM PDT

Demystifying Analytical Validation While Onboarding NGS Tests
Geoffrey Bien, Leah Ames, MS, MLS (ASCP) SCYM
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.

Learning objectives:

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
SEE ABSTRACT HIDE ABSTRACT
Geoffrey Bien
Sr. Project Manager, Analytical Validation (AV) Consult...

Leah Ames, MS, MLS (ASCP) SCYM
Coordinator, Molecular Biology Department - Alverno Lab...
OCT 20, 2020 8:00 AM PDT

How to Avoid Potential Non-Compliance with Regulatory Guidelines in Challenging Times
Martin Wheeler, Julian Renpenning
The complexities of maintaining compliance and audit-readiness in regulated environments take significant time and resources. Learn how to mitigate the risk of potential non-compliance as you return to the lab or transition instrumentation to meet new demands with operational qualification and requalification services from Unity Lab Services. See how you can save time and improve your laboratory’s performance.

Learning objectives:

Discover qualification services for analytical instruments and laboratory equipment

Learn about the range of qualification capabilities that provide improved productivity, single-vendor convenience, and an industry-exclusive, no-charge requalification guarantee
SEE ABSTRACT HIDE ABSTRACT
Martin Wheeler
Regulatory Product Manager, Unity Lab Services part of...

Julian Renpenning
Regional Marketing Manager EMEA, Thermo Fisher Scientif...
OCT 20, 2020 7:00 AM PDT

Analytical and Clinical Validation Requirements for Next Generation Sequencing Laboratory-Developed Tests
Ryan S. Robetorye, M.D., Ph.D.

Molecular Diagnostics Laboratory - Department of Laboratory Medicine and Pathology Mayo Clinic in Arizona
Next generation sequencing (NGS) has revolutionized molecular diagnostic testing. It is important to note that, as with many molecular diagnostic tests currently in clinical use, there are very few FDA-approved or FDA-cleared NGS assays, and thus analytical and clinical assay validation of laboratory-developed tests (LDTs) is essential to the application of NGS technology for clinical diagnostic testing. Both analytical and clinical performance parameters must be established for NGS-based LDTs. Analytical performance parameters include accuracy, precision, reportable range, and reference interval, as well as analytical sensitivity, analytical specificity, and any other parameter that is considered important to assure the analytical performance of a particular test (e.g., specimen stability, carryover). The clinical validity and clinical utility of the testing must also be considered. The College of American Pathologists (CAPs) Molecular Pathology Checklist requirements, universally recognized as providing best-in-class standards for clinical laboratory testing, address the analytical and clinical validation of NGS-based LDTs.

Learning objectives:

Explain the intent of the CAP accreditation requirements for the analytical and clinical validation of NGS-based LDTs listed in the Molecular Pathology Checklist

Identify noncompliant validation issues that are common to many molecular laboratories performing NGS-based testing
SEE ABSTRACT HIDE ABSTRACT
OCT 20, 2020 6:00 AM PDT

Computer System Validation: Your Path to Documenting Data Integrity
Ilyn Santos

Senior Project Manager, Professional Services, Thermo Fisher Scientific
In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality standards. We will cover an overview of total validation process, consulting services, and discuss the components used to document full CSV as well as component documentation details.

Learning objectives:

Learn why CSV is important and how it supports compliance

Learn about considerations of what is needs to be developed and executed to support validation of computerized systems

Learn what is included in CSV consulting services from Thermo Fisher Scientific to help save you time, money, and headaches
SEE ABSTRACT HIDE ABSTRACT

Speakers

Geoffrey Bien
Sr. Project Manager, Analytical Validation (AV) Consulting Services - Thermo Fisher Scientific

Biography
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 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 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

Biography
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.
Randall Albright
Product Manager, Compliance and Professional Services, Thermo Fisher Scientific

Biography
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.
Dean Rainbolt
Technical Applications Manager, Cold Storage Division, Thermo Fisher Scientific

Biography
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.
Ilyn Lyzette Santos
Senior Project Manager, Professional Services, Thermo Fisher Scientific

Biography
Ilyn Lyzette Santos is the senior project manager for Professional Services at Thermo Fisher Scientific. In this role, she is responsible for the development, project management, and execution of CSV engagements along with managing AV projects in Asia Pacific and Japan. Ilyn’s background stems from assay development and validation as well as quality management. She was involved in the development and validation of diagnostic tests for oncology and infectious diseases and spent almost 10 years in quality management roles for ISO 9001 and 13485 as quality management representative, internal auditor, and supervisor of QA/QC departments.
Ryan S. Robetorye, M.D., Ph.D.
Molecular Diagnostics Laboratory - Department of Laboratory Medicine and Pathology Mayo Clinic in Arizona

Biography
Dr. Ryan S. Robetorye received his M.D. and Ph.D. degrees from Baylor College of Medicine in Houston, Texas. He is board certified in Clinical Pathology, Hematology, and Molecular Genetic Pathology and currently works as a Consultant at the Mayo Clinic in Phoenix, Arizona. He serves as the Director of the Clinical Laboratories at the Mayo Clinic as well as the Medical Director of the Coagulation Laboratory and Co-Director of the Molecular Diagnostic-Arizona Laboratory (MDAZL). As a charter member of the College of American Pathologists (CAP) Next-Generation Sequencing Work Group, he helped to develop the first set of clinical laboratory standards for the regulation of laboratories offering NGS-based testing. This group also developed the first proficiency testing programs for clinical laboratories performing NGS tests. Dr. Robetorye is a current member of the College of American Pathologists Genomic Medicine Resource Committee and clinical laboratory Accreditation Committee. His research interests primarily involve hematological malignancies and molecular diagnostics involving gene expression profiling and next-generation sequencing.
Martin Wheeler
Regulatory Product Manager, Unity Lab Services part of Thermo Fisher Scientific

Biography
Since 1997, Martin has worked within the Thermo Fisher Scientific organization focusing on single quadrupole instrumentation using gas & liquid chromatography together with mass spectrometers, CDS, and layered applications. In his current roles Regulatory Product Manager, Martin works closely with our Regulatory Products Support Group to create and update compliance and qualification procedures, and assist our field-based engineers.
Julian Renpenning
Regional Marketing Manager EMEA, Thermo Fisher Scientific

Biography
Julian attended The Technical University of Berlin Biotechnology and specialized in analytical chemistry and bioprocess engineering. In 2011, he started his PhD at The Environmental Research in Leipzig, Germany. In 2015, he continued his career as a postdoc studying analytical method development for hyphenated MS, IRMS, and ICP-MS with gas chromatography. Julian joined Thermo Fisher Scientific in 2019 as a Regional Marketing Manager in EMEA for GC, GC-MS, and IOMS.

About Us

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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