APR 02, 2019 10:00 AM PDT

Instrument Compliance for a Quality System: A Candid Conversation About IQ/OQ/PQ

SPONSORED BY: Thermo Fisher Scientific
C.E. CREDITS: P.A.C.E. CE | Florida CE
Speakers
  • 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.
    • 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.

      Abstract:

      DATE: April 2nd, 2019

      TIME: 10:00AM PDT

      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

       

      LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.


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