In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality standards. We will cover an overview of total validation process, consulting services, and discuss the components used to document full CSV as well as component documentation details.

Learning objectives:

• Discuss why CSV is important and how it supports compliance 
• Describe what needs to be developed and executed to support validation of computerized systems 
• Define what is included in CSV consulting services from Thermo Fisher Scientific to help save you time, money and headaches

Next-generation sequencing (NGS) has become increasingly popular with testing laboratories allowing them to obtain more data in less time and with minimal input.

In this webinar we will explore the new Ion Torrent Genexus system, the first sample to answer all in one instrument, along with the new Oncomine Precision Assay while examining the performance and data.

Learning objectives:

• Discuss the Ion Torrent Genexus system and its sample to answer capabilities
• Discuss the Oncomine Precision Assay and its performance on the Genexus system
• Explain how the Genexus system and Oncomine Precision Assay could fit into your lab

Historically, developing a molecular test within a clinical laboratory has been perceived as a complicated and laborious process. In this webinar, we aim to dispel common misconceptions of laboratory developed tests by inviting an industry expert to share personal experiences and reflections of what it takes for a clinical laboratory to bring an in-house molecular test to market.

Our featured guest is Vijay Singh, Director of Molecular Diagnostics at HealthTrackRx, who will share the advantages, challenges and considerations he encounters while designing and implementing molecular tests at his laboratory.  

After this webinar, attendees will be able to:  

•        Describe advantages of implementing a laboratory developed test  
•        List decision criteria for assay design and target selection   
•        Recall analytical and clinical validation considerations

Real-time PCR, also known as quantitative PCR (qPCR), is the gold-standard for sensitive, specific detection and quantification of nucleic acid targets. This technology allows for powerful assay design algorithms, optimized master mixes, intuitive data analysis software, and diverse applications.  The Analytical Validation of qPCR assays can, however, be a complex and time-consuming task.

In this webinar we will explore the need for the Analytical Validation (AV) and dive into what it takes to complete a qPCR AV.  An experienced AV Project Manager will share their insight into the AV journey focusing on the most accepted validation guidelines, challenges and solutions for a successful Analytical Validation.

Learning objectives:

•        Outline the principal validation guidelines
•        Discuss the challenges that come with an Analytical Validation
•        Discover Thermo Fisher Scientific’s approach to consulting on an AV project

For laboratories that operate within quality management systems for compliance with global standards such as ISO 9001, ISO 13485, ISO 17025, ISO 15189, GxP, etc. and other country-specific regulations, documented verification that laboratory instruments or equipment are installed, operating, and performing according to the manufacturer’s specifications for the design's intended use is a requirement. Developing and 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 manufacture offered testing and documentation to help ensure that instruments and equipment are working and producing accurate data, qualifications are important to every laboratory, even those not operating in a regulated environment.

In this webinar, you’ll hear about the importance of qualification protocols as documentation, their value in process validation, and the importance of maintaining a quality system.

Learning objectives:

• Summarize where a qualification comes from  
• Explain what process validation is and how a qualification (IQ/OQ/PQ) fits
• Discuss what qualifications (IQ/OQ/PQ) provide, how they are organized, and when they are required 
• Review why instrument and equipment qualifications are important to process validation
• Compare what is included in a qualification from Thermo Fisher Scientific and where they are applicable

Discover experiences and insights into the analytical validation (AV) journey during this webinar. Explore the ISO 15189, as well as other relevant validation guidelines, and the need for AV from a regulatory perspective.

Learning objectives:

•        Identify the reasons and requirements to complete an AV
•        Describe the Thermo Fisher Scientific approach to consulting on an AV project
•        Outline assay performance verification and AV as tools to ensure workflows are optimized under the appropriate validation guidelines