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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

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Agenda
  • OCT 20, 2020 10:15 AM PDT
    Instrument Compliance for a Quality System: A Candid Conversation About IQ/OQ/PQ
    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
    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
    Regulatory Product Manager, Unity Lab Services part of...
    Julian Renpenning
    Regional Marketing Manager EMEA, Thermo Fisher Scientif...
  • Analytical and Clinical Validation Requirements for Next Generation Sequencing Laboratory-Developed Tests
    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
  • Computer System Validation: Your Path to Documenting Data Integrity
    OCT 20, 2020 6:00 AM PDT
    Computer System Validation: Your Path to Documenting Data Integrity
    Ilyn Lyzette Santos
    Senior Project Manager, Professional Services, Thermo Fisher Scientific
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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