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 Field Applications Scientist, Brunie White, will share her 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

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 labs, as it allows them to obtain more data in less time and with minimal input.

In this webinar, Dr. Hewitt will share her experience with the Ion Torrent™ Genexus™ System, the first NGS solution that automates the specimen-to-report workflow, along with the Oncomine™ Precision Assay —all while examining the performance characteristics and data.

 Learning objectives:  

• Provide an overview of Peter MacCallum Cancer Centre
• Discuss solid somatic molecular services provided
• Identify key elements in selecting an NGS assay and sequencer 
• Provide an overview of validating the Oncomine Precision Assay

Peace of mind allows us to operate with the confidence that we are doing things the right way and the outcome of our actions is accurate. For PCR instruments, that peace of mind comes with routine temperature verification. Temperature Verification is the process of ensuring a PCR device is reaching specified temperatures by using specialized precision tooling to measure the performance of the sample block. This helps ensure that you obtain the optimal performance level from your PCR instrument and have the necessary performance documentation for accreditation. Join this webinar to hear more about the importance of temperature verification, the specific details of what is included in a thorough temperature verification, and how to have temperature verification performed on your devices.

Learning Objectives: 

• Explain temperature verification and why it is important
• Outline temperature verification solutions
• Discuss methods of temperature verification

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