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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
  • Geoffrey Bien

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

    Coordinator, Molecular Biology Department - Alverno Laboratories
    BIOGRAPHY
  • Randall Albright

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

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

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

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

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

    Regional Marketing Manager EMEA, Thermo Fisher Scientific
    BIOGRAPHY

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Agenda
  • OCT 20, 2020 10:15 AM PDT
    Randall Albright, Dean Rainbolt
    Randall Albright
    Product Manager, Compliance and Professional Services, Thermo Fisher Scientific
    BIOGRAPHY
    Dean Rainbolt
    Technical Applications Manager, Cold Storage Division, Thermo Fisher Scientific
    BIOGRAPHY
  • OCT 20, 2020 9:00 AM PDT
    Geoffrey Bien, Leah Ames, MS, MLS (ASCP) SCYM
    Geoffrey Bien
    Sr. Project Manager, Analytical Validation (AV) Consulting Services - Thermo Fisher Scientific
    BIOGRAPHY
    Leah Ames, MS, MLS (ASCP) SCYM
    Coordinator, Molecular Biology Department - Alverno Laboratories
    BIOGRAPHY
  • OCT 20, 2020 8:00 AM PDT
    Martin Wheeler, Julian Renpenning
    Martin Wheeler
    Regulatory Product Manager, Unity Lab Services part of Thermo Fisher Scientific
    BIOGRAPHY
    Julian Renpenning
    Regional Marketing Manager EMEA, Thermo Fisher Scientific
    BIOGRAPHY
  • Analytical and Clinical Validation Requirements for Next Generation Sequencing Laboratory-Developed Tests
    OCT 20, 2020 7:00 AM PDT
    Ryan S. Robetorye, M.D., Ph.D.
    Molecular Diagnostics Laboratory - Department of Laboratory Medicine and Pathology Mayo Clinic in Arizona
    BIOGRAPHY
  • Computer System Validation: Your Path to Documenting Data Integrity
    OCT 20, 2020 6:00 AM PDT
    Ilyn Santos
    Senior Project Manager, Professional Services, Thermo Fisher Scientific
    BIOGRAPHY
Speakers

  • Geoffrey Bien
    Geoffrey Bien
    Sr. Project Manager, Analytical Validation (AV) Consulting Services - Thermo Fisher Scientific
    BIOGRAPHY
  • Leah Ames, MS, MLS (ASCP) SCYM
    Leah Ames, MS, MLS (ASCP) SCYM
    Coordinator, Molecular Biology Department - Alverno Laboratories
    BIOGRAPHY
  • Randall Albright
    Randall Albright
    Product Manager, Compliance and Professional Services, Thermo Fisher Scientific
    BIOGRAPHY
  • Dean Rainbolt
    Dean Rainbolt
    Technical Applications Manager, Cold Storage Division, Thermo Fisher Scientific
    BIOGRAPHY
  • Ilyn Lyzette Santos
    Ilyn Lyzette Santos
    Senior Project Manager, Professional Services, Thermo Fisher Scientific
    BIOGRAPHY
  • Ryan S. Robetorye, M.D., Ph.D.
    Ryan S. Robetorye, M.D., Ph.D.
    Molecular Diagnostics Laboratory - Department of Laboratory Medicine and Pathology Mayo Clinic in Arizona
    BIOGRAPHY
  • Martin Wheeler
    Martin Wheeler
    Regulatory Product Manager, Unity Lab Services part of Thermo Fisher Scientific
    BIOGRAPHY
  • Julian Renpenning
    Julian Renpenning
    Regional Marketing Manager EMEA, Thermo Fisher Scientific
    BIOGRAPHY
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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