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.


Microarray support

 

On-demand videos

Genome-wide transcriptome studies are powerful ways of identifying changes between groups or conditions, and characterizing biological processes. This demo shows how to efficiently compare expression differences on the Clariom D microarray platform using Transcriptome Analysis Console 4.0 (TAC). Within this demo, various strategies are illustrated: Identification of groups using Exploratory Grouping Analysis, comparison of sub-groups based on high- or low-expression of a gene of interest, and differential expression analysis between experimental groups. TAC enables users to quickly and efficiently do popular genome-wide transcriptome analysis strategies and visualizations such as PCA, Alternative-Splicing Analysis, Hierarchical Clustering, and Functional Pathway Analysis.

About the speaker:

Schleifer

Rob Schleifer, PhD

Field Application Scientist, Southeastern U.S., Thermo Fisher Scientific

Rob Schleifer is a Field Application Scientist at Thermo Fisher Scientific for microarray technologies in the gene expression, cytogenetics, and genotyping applications. He has been in this role since 2018.  Before joining Thermo Fisher, Rob studied cancer genomics at the Medical College of Georgia at Augusta University, where he earned his PhD in Biotechnology and Genomic Medicine. Prior to joining Thermo Fisher Scientific, Rob’s research focus revolved around on cancer treatment response, genomic signatures, and biomarker identification.

Looking for more help with our microarray products and solutions? Get help with product selection, troubleshooting, and instrument support across our portfolio of products.

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Genotyping is important in research of genes and gene variants associated with disease. This demo will show how to effectively run genotyping analysis using, as an example, the PMRA microarray with the Axiom Analysis Suite(AxAS) program. Users will be able to not only be able to run QC check and genotyping, but easily visualize the data with multiple graphical options. Individual marker cluster plots can be investigated and genotyping data can be exported in multiple formats for various downstream applications like PLINK.

About the speaker:

Schleifer

Michelle Desrosiers

Staff Scientist – Field Bioinformatics Scientist (Axiom Platform), Field Application Scientist CT (Affymetrix Microarray Products), Thermo Fisher Scientific

Michelle Desrosiers is currently a Field Bioinformatic Specialist for the Axiom GeneChip product line. She supports customers on the west coast who are primarily focused on genotyping and copy number analysis in the area of Agri-genomics. Michelle also supports her local territory of Connecticut for all GeneChip microarray products and applications. She has been a part of Thermo Fisher for over 15 years. Prior to becoming a bioinformatics specialist, she was a part of the Technical Application Specialist team for 8 years.

Applied Biosystems Axiom arrays can be designed to detect copy number changes and Loss of Heterozygosity (LOH), in addition to genotyping Single Nucleotide Polymorphisms (SNPs) and insertions and deletions (indels). This tutorial will explore copy number analysis with the human Precision Medicine Diversity Array (PMD array). Along with whole-genome genotyping, the PMD Array also enables copy number analysis for regions of pharmacogenetic interest, as well as whole-genome copy number discovery analysis. Viewers will gain expertise in how to review copy number quality control (QC) metrics, explore copy number results for specific regions of pharmacogenetic interest, and visualize whole-genome copy number variation and allelic imbalances including gains, losses, and LOH, all using Axiom Analysis Suite software.

About the speaker:

Marci_Sullivan

Marci Sullivan

Staff Scientist – Field Applications (Axiom Bioinformatics), Thermo Fisher Scientific

Marci Sullivan works within Thermo Fisher Scientific’s Microarray Field Applications team, with a focus on genotyping and copy number data analysis. She supports customers with a wide range of applications, from association studies to precision medicine to direct-to-consumer testing. She has 17 years of experience in the genomics field, with prior background as a Field Applications Specialist at Affymetrix, supporting customers with immuno-oncology research and reproductive health/molecular diagnostic applications. She holds an M.S. in Bioinformatics and a certificate in Data Visualization from NYU.

Capillary Electrophoresis Support

 

An increasingly acknowledged problem is that cells grown in vitro can become misidentified or contaminated with other unrelated cell lines. Publishing with the wrong cell line can have a negative impact on a scientist's ability to obtain funding or get published.

Join us for this live webinar to learn about STR DNA profiling and the importance of human cell line authentication as part of our Connect2Science Webinar Series.

About the speaker:

Schleifer

Audra McKinzie

Field Application Scientist, Thermo Fisher Scientific

Audra McKinzie is a Field Application Scientist at Thermo Fisher Scientific. She lives in the San Francisco Bay Area. Audra is a passionate scientist and educator, who supports Next-Generation Sequencing and Capillary Electrophoresis Applications. In her free time, Audra loves hiking, bicycling, and re-purposing discarded objects.

Are you doing fragment analysis via capillary electrophoresis? If so, GeneMapper is required for almost all fragment analysis applications.

Join us on this informative webinar as an introduction or a refresher for this important software tool as part of our Connect2Science Webinar Series.

About the speaker:

Marci_Sullivan

Marc Basterretche

Senior Field Application Scientist, Thermo Fisher Scientific

Marc Basterretche is a Senior Field Application Scientist at Thermo Fisher Scientific. He lives in Los Angeles, California. Marc is a passionate scientist and educator, who supports Next-Generation Sequencing and Capillary Electrophoresis Applications. In his free-time, Marc loves playing softball, basketball, spending time with family, and has a love/hate relationship with running.

If you are running CE sequencing and require accurate and confident base-calling for minor variants, you will likely require an orthogonal test with NGS and/or qPCR.

Join us for this live webinar to learn more about how Minor Variant Finder software is a great solution for such an orthogonal test as part of our Connect2Science Webinar Series.

About the speaker:

Marci_Sullivan

Marc Basterretche

Senior Field Application Scientist, Thermo Fisher Scientific

Marc Basterretche is a Senior Field Application Scientist at Thermo Fisher Scientific. He lives in Los Angeles, California. Marc is a passionate scientist and educator, who supports Next-Generation Sequencing and Capillary Electrophoresis Applications. In his free-time, Marc loves playing softball, basketball, spending time with family, and has a love/hate relationship with running.

Compliance support

 

On-demand webinars

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.  

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

About the speakers:

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Geoffrey Bien

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

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.

Still have questions about analytical validation? Have a sales specialist contact you.

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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.

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

About the speakers:

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Randall Albright

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.

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Dean Rainbolt

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.

Trust your hardware qualifications to the company that designed your system. Request your quote for qualification services today—because science  can't wait on noncompliant instruments.

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Style Sheet for Global Design System