A straightforward path toward regulatory compliance, data integrity, and computer systems validation

Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing.  Regulatory agencies require that the many components of the system implemented, from assays to data integrity, be qualified and validated to meet regulatory guidance in a CGMP environment.  Therefore, when choosing a microbial testing solution, it’s important to have a clear path toward regulatory compliance from the start in order to avoid any costly complications down the road.

In this webinar we will share experiences with a variety of strategies toward implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.

Learning Objectives:

• Discuss the regulatory guidance around validation of a microbial testing and identification system in the CGMP environment
• Explain the details of a microbial identification system designed to meet regulatory requirements
• Identify a complete computer systems validation plan, including data integrity, IQ/OQ/PQ, and 21 CFR part 11 compliance

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, we will explore the Ion TorrentTM GenexusTM System, the NGS solution that automates the specimen-to-report workflow, along with the OncomineTM Precision Assay—all while examining the performance and data. 

Learning objectives: 

• Learn about the Genexus System and its sample-to-answer capabilities 
• Learn about the Oncomine Precision Assay and its performance on the Genexus System 
• Discuss how the Genexus System and Oncomine Precision Assay could fit into your lab 

Your path to documenting data integrity

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

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

In this webinar, we will explore the need for AV and dive into what it takes to complete a qPCR AV. An experienced AV Project Manager, Victoria Quiett, will share her insight into the AV journey, focusing on the most accepted validation guidelines, as well as challenges and solutions for a successful AV.

Learning objectives:

• Outline the principal validation guidelines

• Discuss the challenges that come with an AV

• Discover the way Thermo Fisher Scientific consults 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