Addressing Data Integrity Gaps: Does Your Lab Have a Strategy?

Data integrity is paramount in today’s digital world. Data Integrity Insights helps your lab stand up to any regulatory examination by informing you about the latest global enforcement trends and the strategies you can use to stay compliant. Presenting uncompromised results and maintaining compliance with the latest regulations and standards, including those issued by the pharmaceutical, environmental and food regulatory bodies, is a necessity.

The traditional approaches to laboratory data integrity are insufficient to meet today’s increased scrutiny of computerised systems and the terabytes of data they produce. To successfully present your results, you must be prepared to prove that your data have not been compromised—and that can be a challenge.

Does your lab have a data integrity strategy? Are data integrity gaps putting your company at risk?

Learn how to perform data process mapping on a chromatographic process from the set-up of analysis through calculating the reportable result. From this map, the data integrity gaps can be identified, and the risk assessed to determine how critical the gaps are so that a plan and strategy to remediate or remove the risks can be implemented.

 

What you will learn

  • Understand the scope of a data integrity program
  • How to perform data process mapping on a chromatographic process to identify data integrity gaps, assess the risk posed by those gaps, and determine how to remediate or solve them.
  • Understand options for short-term remediation and long-term solutions

 

Who should attend

Analytical chemists, technicians, laboratory managers, regulatory affairs personnel and others working in R&D and QA/QC in the pharmaceutical industry.

 

Bob McDowall
Director, RD McDowall
Limited, Bromley,
Kent, UK

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Industrialising High-Throughput Glycoproteomics Using AI for Clinical Use

Cancer is a leading cause of death worldwide and there is a great movement globally to develop new treatments and advance how cancer is diagnosed. Technology has been a great help, particularly in recent years, and now there’s new innovation that could take our cancer diagnosis and treatment to a new level.

According to an article published by The Guardian, doctors, scientists and researchers have built an artificial intelligence model that can accurately identify cancer in a development they say could speed up diagnosis of the disease and fast-track patients to treatment. This is but one of many new developments that include AI technology in cancer diagnosis as well as treatment.

In this webinar, we learn the predictive powers of artificial intelligence combined with cutting-edge mass spectrometry to discover clinically relevant biomarkers that can only be revealed by high-resolution analysis of the glycoproteome. This presentation is for all who are interested to learn more about the real-world clinical application of glycoproteomics on cancer diagnosis.

 

Speaker

Dr. Low Ley Hian
Director of Development
InterVenn Biosciences

 

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Gather Assay Materials

Energy metabolism drives cell function in health and disease. The landscape of therapeutic discovery is rapidly evolving, and cellular metabolism has emerged as the critical driver of a range of common diseases. Cell biology functions as a network of signaling, pathways, and checkpoints — with cellular metabolism as a central orchestrator to fuel many cellular processes.

The development of safe and effective drugs requires an understanding of genes, proteins, and pathways that may be key intermediates and potential candidates for drug target intervention. Cellular processes are dynamic, and metabolic programs are the upstream determinants of cellular outcomes. Identification and validation of potential drug targets requires a comprehensive view of those upstream drivers to modulate cell response and safely and effectively intervene.

Agilent Seahorse XF technology provides functional, live-cell metabolic measurements for a more direct measure and a deeper understanding of cellular processes. In this training webinar, you will learn about the fundamentals of Agilent Seahorse XF technology, the typical XF assay workflow, the Agilent XF Assay Learning Center resource, and the required and recommended materials to perform a successful XF assay.

 

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Food and Cannabis Elemental Analysis Part 2: Elemental Sample Prep for the Food and Agriculture Lab – Optimizing Your System for High Matrix Samples

Trace elemental analysis of foods and cannabis products is essential to ensure that products are suitable for consumption. The analysis of minerals and additional trace elements is also important because it provides labelling information that is required when these products are used as nutritional.

Agilent has presented a webinar series that focuses on elemental sample preparation to optimise high matrix samples in the food and agriculture testing space.

 

Part 1

We will cover the entire Agilent elemental portfolio. Each of the different instruments’ strengths and how they meet the challenges that food and cannabis labs have.

 

Part 2

We will focus on preparing your samples, including microwave digestion. We will also cover how to optimize your system for high matrix samples and a diverse sample set.

 

Part 3

We will put it all together, with running samples live in the lab. We will also share additional tips and tricks for obtaining excellent analytical results in these difficult matrices.

This focused information on spectroscopy applications is valuable for the emerging cannabis market as well as analysts who are seeking to master skills for food testing.

 

Speakers

Jenny Nelson, PhD
Application Scientist
Agilent Technologies, Inc.

Jenny Nelson received her Ph.D. in Analytical Chemistry from the University of Cincinnati in 2007, and her MBA from Saint Mary’s College of California in 2011. Currently, Jenny is an Application Scientist for the Life Science and Chemical Analysis team at Agilent Technologies, joining in 2012 (with a step away in 2019). Jenny is also an Adjunct Professor in the Department of Viticulture and Enology at the University of California, Davis, since 2013. Jenny has been very active with AOAC and ASTM over the past eight years, serving on expert review panels, chairing committees, and volunteering to develop new methods needed by the industry. Jenny has extensive experience in operating and method development for Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), Microwave Plasma Atomic Emission Spectroscopy (MP-AES). Jenny has broad knowledge and experience in different speciation analysis for many sample matrices using GC-ICPMS and LC-ICPMS. As well as vast experience with sp-ICP-MS for many applications.

 

Greg Gilleland
Application Scientist
Agilent Technologies, Inc.

Greg began his spectroscopy career in 1987 in Colorado, working at a series of environmental labs. After 14 years working in the world of commercial environmental labs, he moved on to a spectroscopy instrument manufacturer where he performed service and sales functions over the course of 11 years. He has been with Agilent Technologies, Inc., since 2012 in the role of Application Scientist for ICP-OES, MP-AES and AA products.

 

Mark Kelinske
Application Scientist
Agilent Technologies, Inc.

Mark Kelinske is an Applications Chemist with Agilent Technologies, specializing in advanced ICP-MS and ICP-MS/MS techniques. He received his undergraduate and graduate degrees from Texas A&M University in College Station, TX. Prior to Agilent, Mark was a senior research scientist and research group manager with Southern Research Institute in Birmingham, AL, where he focused on low-level analytical chemistry, method development, and research program management.

 

Chris Conklin
Atomic Spectroscopy Product Specialist
Agilent Technologies, Inc.

With a degree from the University of Wisconsin – Eau Claire, Chris worked in, and lead, a quality control lab testing fine chemicals ranging from reagent grade to high purity. Over the course of 12 years in that role, Chris has run a variety of atomic elemental instruments and techniques including AA, ICP-OES, and ICP-MS. As a result, he has seen most of the periodic table in its elemental form and overcome the associated interferences. In 2018, Chris brought that knowledge and experience to his current role with Agilent as the Product Specialist for Atomic Spectroscopy supporting AA, MP-AES, and ICP-OES for the Eastern US.

 

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Accelerating Drug Development, QC & Manufacturing

During this webinar we will describe the newest breakthrough technologies and applications of Raman, Laser based Infrared and UV-Vis Spectroscopy in Pharma.

This will include use of transmission Raman as an alternative to UPHPLC for content uniformity and polymorph studies. Furthermore, use of a next generation IR instrument using a quantum cascade laser will be described for chemical imaging studies including analysis of tablet component distribution, polymorph distribution, salt exchange and stability studies. New breakthrough technologies for ultra-fast and productive parallel temperature based kinetic studies, protein folding, DNA melting and other temperature related UV-Vis measurements will end this overview.

 

Jan Wülfken
Product Specialist – Molecular Spectroscopy
Agilent Technologies

Dr. Wuelfken has worked for many years as Product Specialist for Agilent Technolgies in many region of the world, supporting Molecular ( Raman FTIR, Fluorescence nad UV-Vis/NIR) Spectroscopy business.

 

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Raw Material Identification Through All Kinds of Package Materials

In this webinar we will focus on raw material identification and will give a detailed comparison about the different spectroscopic techniques FTIR, NIR and Raman as well as an a new special Raman way called “SORS” to measure though opaque containers.

Jan Wülfken
Product Specialist – Molecular Spectroscopy
Agilent Technologies

Dr. Wuelfken has worked for many years as Product Specialist for Agilent Technolgies in many region of the world, supporting Molecular ( Raman FTIR, Fluorescence nad UV-Vis/NIR) Spectroscopy business.

 

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Making Better Connections in GC and GC/MS Systems

This presentation will cover products from Agilent that make GC connections more robust by utilising new technologies that makes connections easier, leak free and more inert for any application.

Topics covered include: Self Tightening Stainless Column Nuts and ferrules, Press Fits, UltiMetal Plus and Stainless Steel Capillary Tubing, Ferrule Pre-swaging installation tool and MS interface installation tool, among others.

Mark Sinnott
Application Engineer
Agilent Technologies, Inc.

Mark Sinnott works for Agilent Technologies as a Technical Support Engineer in the Consumables and Supplies Division (CSD). In his position at Agilent, Mark performs technical support and applications assistance to gas chromatographers worldwide. He has more than 22 years of experience in gas chromatography, including environmental analysis of compounds in air, soil and water matrices, including dissolved gas analysis for the electrical industry. Mark holds a Master’s Degree in Chemistry from California State University, Sacramento, and currently resides in Twin Falls Idaho.

 

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Analysis of Biopharmaceuticals: A Deeper Dive into Bioseparations

Ensuring the safety and efficacy of biotherapeutics from research to development, and then from manufacturing to quality control is essential to bring a product to market. Large molecules pose unique challenges for biotherapeutic analyses in that they often require running a panel of tests to ensure product efficacy and safety.

Industry efforts have evolved towards comprehensive analytical workflows that enable researchers to monitor critical quality attributes (CQAs) of highly complex and diverse biotherapeutic molecules.

Part 2: A Deeper Dive into Bioseparations

In the second session of this series we will discuss the range of bioseparation approaches used for characterization of CQAs in more detail. This includes solutions available for native (Size Exclusion, Ion Exchange, HIC) and reduced state (RP, HILIC) bioseparations for analysis of mAbs and other biotherapeutics.

 

Donna Potts
Biopharma Market Specialist EMEA IDO
Agilent Technologies

Donna is a Biopharma Market Specialist for Agilent Technologies; over the last decade she has been responsible for business development for Agilent analytical solutions in the Biopharma market space. Donna has worked extensively with biomolecules during her career, with a strong emphasis on Life Science and Biopharma applications using LC-MS.

After completing Postdoctoral Research at Boston University School of Medicine, she worked as an application specialist before becoming a Market Specialist in 2013. Donna holds a PhD in Analytical Chemistry from The University of Manchester, UK, where her studies focused on protein quantitation using mass spectrometry.

 

Cecilia Mazza
Product Specialist, EMEA IDO – Chemistries & Suppliers
Agilent Technologies

With more than 20 years of professional experience, Cecilia is presently the Product Specialist for columns and supplies at Agilent. Supporting distributors and laboratory users in the analysis and purification of small and large molecules, for a wide range of LC and GC applications as well as sample preparation.

Cecilia holds a Ph.D. in Chemical Engineering from Rensselaer Polytechnic Institute in US.

 

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Analysis of Biopharmaceuticals: Introduction to Workflows

Ensuring the safety and efficacy of biotherapeutics from research to development, and then from manufacturing to quality control is essential to bring a product to market. Large molecules pose unique challenges for biotherapeutic analyses in that they often require running a panel of tests to ensure product efficacy and safety.

Industry efforts have evolved towards comprehensive analytical workflows that enable researchers to monitor critical quality attributes (CQAs) of highly complex and diverse biotherapeutic molecules.

Part 1: Introduction to Workflows

This presentation will provide an insight into the basics of the biopharma industry and introduce how analytical tools can be utilised as part of comprehensive workflows for characterisation of CQAs.

 

Donna Potts
Biopharma Market Specialist EMEA IDO
Agilent Technologies

Donna is a Biopharma Market Specialist for Agilent Technologies; over the last decade she has been responsible for business development for Agilent analytical solutions in the Biopharma market space. Donna has worked extensively with biomolecules during her career, with a strong emphasis on Life Science and Biopharma applications using LC-MS.

After completing Postdoctoral Research at Boston University School of Medicine, she worked as an application specialist before becoming a Market Specialist in 2013. Donna holds a PhD in Analytical Chemistry from The University of Manchester, UK, where her studies focused on protein quantitation using mass spectrometry.

 

Cecilia Mazza
Product Specialist, EMEA IDO – Chemistries & Suppliers
Agilent Technologies

With more than 20 years of professional experience, Cecilia is presently the Product Specialist for columns and supplies at Agilent. Supporting distributors and laboratory users in the analysis and purification of small and large molecules, for a wide range of LC and GC applications as well as sample preparation.

Cecilia holds a Ph.D. in Chemical Engineering from Rensselaer Polytechnic Institute in US.

 

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ICH Q3D Guideline: Elemental Impurities Analysis in Pharmaceutical Products

In the first half of this webinar, we will introduce the ICH/USP regulation and how to measure elemental impurities with the Agilent ICP-OES and/or ICP-MS instruments.

The second part of the webinar will focus on the Agilent software compliance solutions where you will see our options for data integrity as well as software features that simplify validating methods according to ICH/USP.

 

Uwe Noetzel
EMEAI Technical Coverage and Solutions
Agilent Technologies

Uwe joined Agilent as a GC/LC MS specialist in 1989. Since 1994 he is involved in ICP-MS as a Product Specialist. In 2001 he became part of the Agilent International Distributor Organization (IDO). Today his responsibility is the full Agilent Atomic Spectroscopy Portfolio in IDO

 

Andrew Brotherhood
Atomic Spectroscopy Application Engineer
Agilent Technologies

Andrew has over 15 years’ hands-on experience with ICP-MS, ICP-OES and Ion Chromatography instrumentation. He has mainly worked in the pharmaceutical analysis industry gaining significant experience with developing and validating methods to pharma regulations. Andrew started working for Agilent as a full time employee in January 2018 working as an Atomic Spectroscopy Application Engineer based at the Agilent Centre of Excellence in the UK.

 

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