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
   

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
   

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