This presentation looks at common issues encountered with DMSO-solvated compounds in HTS libraries and, current methods for identifying and tracking these issues. It also introduces applications of a novel high resolution and imaging processing instrument (HIAPI) for rapid assessment and quality control of HTS library compound library quality.
Idealp Pharma Hits & Leads Optimisation Case Study 1MehdiChelbi
Idealp-Pharma provides integrated drug discovery services from hits identification to lead optimization. They have expertise in medicinal chemistry, biology, computational sciences, and ADMET testing. One case study described the optimization of initial hits into leads over 9 months through iterative chemical synthesis, testing, and analysis to identify 3-6 promising chemical series. Services include biological screening, computational analysis, synthesis, ADMET testing, and working with customers throughout the drug discovery process.
A process has been developed that integrates the automation of blood sample collection, plasma transfer, preparation and analysis for drug discovery using LC/MS or LC/MS/MS detection. The process uses a Culex automated blood sampler to collect samples from rats, a TECAN robot to transfer plasma to a 96-well plate and precipitate samples, and templates to analyze samples. Investigations found no significant differences between automated and manual processes for obtaining compound concentrations for preliminary pharmacokinetic calculations. Data for atenolol agreed with published data, demonstrating the validity of the integrated automated process.
The Andrej Sali Lab Processes Millions of Small Files with PanasasPanasas
The University of California, San Francisco (UCSF) needed a computing solution that could process millions of small files as quickly as possible for researchers identifying the structural similarities of protein models. They needed to eliminate poor storage system performance and significantly decrease administrator management time and within a limited budget. Here is how the fully integrated software/hardware solution including the Panasas Operating Environment and the PanFS parallel file system with the Panasas DirectFLOW protocol helped UCSF to overcome the challenges.
Greg Labbe: quality control issues in housing constructionjeff_ranson
Greg Labbe of BlueGreen consulting showcases many quality control issues with new housing construction. Presented to the Toronto Certified Sustainable Building Advisor Program
Sensory evaluation refers to evaluating food using human senses. It is done to develop new products, improve existing ones, ensure quality standards, and determine consumer acceptance. Components of a food composition table are also discussed. Methods of cooking can make food healthier by using less oil and having shorter cooking times to retain nutrients. Ingredients can be substituted to reduce saturated fat and increase fiber. Food presentation and flavoring are also important to make dishes more appealing.
This document discusses food quality parameters and methods for analyzing food products. It outlines factors that contribute to food quality like appearance, taste, and nutritional value. Physical, chemical, and microbiological tests are used to analyze raw materials and finished products to ensure safety and purity. Parameters like moisture, fat, protein, and packaging materials are evaluated using methods like the hot air oven test and chemical analysis. Instrumental techniques like gas chromatography-olfactometry and electronic nose are also used to objectively measure organoleptic properties and identify volatile compounds that influence flavor.
Expanding the Compound Management toolkit: leveraging technology to streamlin...Pierre Baillargeon
The continual evolution of compound management labs in terms of sample capacity and capabilities provides opportunities to improve the associated QA and QC operations. As new technologies enable support of greater plate densities and library sizes, new approaches to QA and QC must follow suit.
• Review of potential for error in compound management labs and impact of new technology on QA/QC efficiency
• Leveraging sample color to quickly identify problems
• Novel methods for monitoring the health of large sample libraries over time
• Correlating visual properties of solubilized samples to experimental results and calculated properties
Accelrys Announces Experiment Knowledge Base (EKB) for Enterprise Lab ManagementBIOVIA
The document discusses Accelrys' new Experiment Knowledge Base (EKB) solution for enterprise lab management. EKB aims to improve lab efficiency, knowledge capture and reuse by transforming scientific data into actionable knowledge. It integrates with existing lab systems and uses preconfigured interfaces and services to help customers intelligently plan, execute, analyze and manage materials development experiments. EKB is expected to accelerate innovation by reducing experiment repetition and costs while enabling scientists to learn from past experiments.
Idealp Pharma Hits & Leads Optimisation Case Study 1MehdiChelbi
Idealp-Pharma provides integrated drug discovery services from hits identification to lead optimization. They have expertise in medicinal chemistry, biology, computational sciences, and ADMET testing. One case study described the optimization of initial hits into leads over 9 months through iterative chemical synthesis, testing, and analysis to identify 3-6 promising chemical series. Services include biological screening, computational analysis, synthesis, ADMET testing, and working with customers throughout the drug discovery process.
A process has been developed that integrates the automation of blood sample collection, plasma transfer, preparation and analysis for drug discovery using LC/MS or LC/MS/MS detection. The process uses a Culex automated blood sampler to collect samples from rats, a TECAN robot to transfer plasma to a 96-well plate and precipitate samples, and templates to analyze samples. Investigations found no significant differences between automated and manual processes for obtaining compound concentrations for preliminary pharmacokinetic calculations. Data for atenolol agreed with published data, demonstrating the validity of the integrated automated process.
The Andrej Sali Lab Processes Millions of Small Files with PanasasPanasas
The University of California, San Francisco (UCSF) needed a computing solution that could process millions of small files as quickly as possible for researchers identifying the structural similarities of protein models. They needed to eliminate poor storage system performance and significantly decrease administrator management time and within a limited budget. Here is how the fully integrated software/hardware solution including the Panasas Operating Environment and the PanFS parallel file system with the Panasas DirectFLOW protocol helped UCSF to overcome the challenges.
Greg Labbe: quality control issues in housing constructionjeff_ranson
Greg Labbe of BlueGreen consulting showcases many quality control issues with new housing construction. Presented to the Toronto Certified Sustainable Building Advisor Program
Sensory evaluation refers to evaluating food using human senses. It is done to develop new products, improve existing ones, ensure quality standards, and determine consumer acceptance. Components of a food composition table are also discussed. Methods of cooking can make food healthier by using less oil and having shorter cooking times to retain nutrients. Ingredients can be substituted to reduce saturated fat and increase fiber. Food presentation and flavoring are also important to make dishes more appealing.
This document discusses food quality parameters and methods for analyzing food products. It outlines factors that contribute to food quality like appearance, taste, and nutritional value. Physical, chemical, and microbiological tests are used to analyze raw materials and finished products to ensure safety and purity. Parameters like moisture, fat, protein, and packaging materials are evaluated using methods like the hot air oven test and chemical analysis. Instrumental techniques like gas chromatography-olfactometry and electronic nose are also used to objectively measure organoleptic properties and identify volatile compounds that influence flavor.
Expanding the Compound Management toolkit: leveraging technology to streamlin...Pierre Baillargeon
The continual evolution of compound management labs in terms of sample capacity and capabilities provides opportunities to improve the associated QA and QC operations. As new technologies enable support of greater plate densities and library sizes, new approaches to QA and QC must follow suit.
• Review of potential for error in compound management labs and impact of new technology on QA/QC efficiency
• Leveraging sample color to quickly identify problems
• Novel methods for monitoring the health of large sample libraries over time
• Correlating visual properties of solubilized samples to experimental results and calculated properties
Accelrys Announces Experiment Knowledge Base (EKB) for Enterprise Lab ManagementBIOVIA
The document discusses Accelrys' new Experiment Knowledge Base (EKB) solution for enterprise lab management. EKB aims to improve lab efficiency, knowledge capture and reuse by transforming scientific data into actionable knowledge. It integrates with existing lab systems and uses preconfigured interfaces and services to help customers intelligently plan, execute, analyze and manage materials development experiments. EKB is expected to accelerate innovation by reducing experiment repetition and costs while enabling scientists to learn from past experiments.
This file includes the SLAS2013 presentations of Paul A. Johnston of University of Pittsburgh; Douglas Auld of Novartis Institutes for Biomedical Research; and Lisa Minor of In Vitro Strategies, LLC.
Innovative Drug Pipeline Solutions: Medicinal Chemistry, Process Chemistry, cGMP API Manufacturing. 105+ global clients. 120,000 sq.ft. facilities located in Research Triangle Park, NC USA. FDA inspected and DEA registered.
Persistent has expertise in developing software and drivers for multiple analytical instruments including LC, GC, MS, PCR, bioinformatics, NGS, CE, and flow cytometry. They have over 20 years of experience producing chromatography software and over 15 years of experience developing instrument drivers for various systems. Persistent also has an in-house laboratory for development and testing.
CoreRx is a dosage form development company specializing in formulation development, analytical development, and clinical manufacturing. They focus on client satisfaction, quality science, strong communication, timeline management, and client goals. CoreRx offers preformulation, formulation development, analytical services, manufacturing, packaging, labeling, and stability services. They have experienced scientific staff and capabilities including specialized dosage forms. CoreRx aims to get clients' products to market quickly while maintaining compliance.
Describes the integrated use of several common analytical informatics tools / platforms in the lab and the VM space to maximize access. It also describes a variety of customized additions including links to proprietary databases, barcode utilization, adding value to analytical data, and one stop shopping for data analysis / reporting. The impact is that the same FTEs can produce >3 fold more results!
Sandor Szalma (Janssen) gives an overview of this potential Pistoia Alliance working group during the "Dragons' Den" session of the Pistoia Alliance Conference in Boston, MA, on April 24, 2012.
Appalla Venkataprabhakar and I presented this at the Oracle\'s Annual Clinical Development and Safety Conference 2010 at Hyderabad, India on 6th October 2010.
Luke Lightning presented on pre-clinical drug development and ADME (absorption, distribution, metabolism, excretion) studies. He discussed why ADME is important for assessing a compound's developability. He provided examples of his experience conducting ADME studies at Alquest Therapeutics and a previous company. The presentation covered regulatory considerations for ADME studies, in vitro and in vivo study types and costs, and options for conducting studies in-house or outsourcing them. An example ADME work plan was presented, along with a summary of key points and future directions for ADME research.
The document is a resume for Kanagasabapathi S., highlighting his expertise and 10+ years of experience in bioanalytical method development and drug discovery. It summarizes his responsibilities developing over 1000 analytical methods for small molecules, conducting ADME assays, and managing projects. Currently he works as a Research Scientist at Syngene International Ltd, where he leads projects and trains junior scientists.
The SCYNEXIS analytical research and development team consists of experienced scientists who develop and validate analytical methods for starting materials, active pharmaceutical ingredients, and synthetic intermediates according to regulatory guidance documents. SCYNEXIS has state-of-the-art instrumentation and the expertise to solve complex analytical problems and meet aggressive timelines. Their services include method development and validation, assay testing, forced degradation studies, and structural identification.
The Genome-in-a-Bottle Consortium aims to develop reference materials for clinical applications of human genome sequencing. The National Institute of Standards and Technology is partnering with the Food and Drug Administration and other organizations to produce reference genomes that can be used to evaluate the performance of sequencing instruments and ensure consistency across platforms. The consortium will select candidate reference genomes, experimentally characterize the materials, integrate the data to produce consensus variant calls, and define performance metrics for end users. The goal is to provide a trusted source of reference materials to support regulatory oversight and commercial use of genome sequencing.
This document summarizes information about Novo Informatics, a drug discovery startup incubated at IIT Delhi. It provides an overview of computational aided drug design (CADD) and its advantages. Novo Informatics' mission is to accelerate drug discovery through CADD approaches like virtual screening and hit optimization. It has expertise in various areas of the drug discovery process and access to chemical libraries and supercomputing facilities at IIT Delhi. The company also engages in target analysis, molecule synthesis and validation services for clients.
Pete Young is an analytical scientist with over 25 years of experience in GMP and non-GMP analytical chemistry laboratory environments at Eli Lilly and Company. He has extensive experience operating and maintaining laboratory equipment, developing analytical methods, and analyzing samples using techniques such as HPLC, GC, Karl Fischer, UV-Vis, and dissolution. Pete is proficient with various computer programs for data management and reporting. He enjoys working independently while also collaborating as part of a team. Pete is safety-conscious and always looking for ways to improve work processes.
The document discusses process improvement metrics and methods at the Jet Propulsion Laboratory (JPL). It notes that while JPL aims to perform like a CMMI Level 4 organization, it is actually assessed at CMMI Level 3. It outlines some of JPL's data collection methods and key questions around understanding their software environment. Some of the processes in place include tailoring software development processes and measuring performance against processes. Risks, strengths and recommendations are identified from process reviews.
Dear Sir,
I take pleasure in introducing STABICON LIFE SCIENCES, a focused Analytical Methods Development/Validation & Stability Centre.
Stabicon Life Sciences is a Contract Research Organization. Services provided by Stabicon currently include specialized and focused services for complete stability study management including storage of samples, analysis and preparation of required documentation, associated analytical method development and validations for different phases of drug development program.
We are committed to complete confidentiality and protection of client’s intellectual property. We are committed to quality and reliability of our service. We also remain committed to our customers to deliver on agreed objectives and committed timelines and a promise to ourselves to be a reliable partner fulfilling requirements of our customer’s .Now we have been approved by few National & Multinational companies, who have now placed order with us for conducting stability studies on their products. We have been audited on behalf of Health Canada and have been approved for performing analytical and stability work for Canadian companies. We are also in process getting registration of our company with USFDA as cGMP testing analytical company located outside United States.
We have come across your company as a reputed organisation.We are looking for business partners with whom we can associate by acting as your back office support from India. By doing this it will allow you to allocate your resources for strategic projects. It will also allow you to save on your budgets significantly by taking advantage of Indian costs with International Quality Services offered by Stabicon.You may please visit our website www.stabicon.com for more details.
Looking forward to your response.
Thanking you and assuring our best service at all time.
Regards,
Vijay
Project Director
Stabicon Life Sciences Pvt Ltd
Mobile: +919591974355/080-41714280
www.stabicon.com
This document provides an overview of Stabicon Life Sciences, an analytical testing laboratory located in Bangalore, India. It describes the facility's 15,000 square foot built area, cGMP and cGLP compliance, and management by experienced professionals. Services offered include stability programs, analytical development and validation, bio-waiver studies, quality control testing, and microbiological testing.
Dilip Shah is seeking a position in pharmaceutical research utilizing his skills in laboratory instrumentation and assays. He has over 15 years of experience in compound management, high-throughput screening, and assay operations at major pharmaceutical companies. His technical skills include automated liquid handling systems, fluorescence and luminescence detection instruments, and assay techniques for targets such as ion channels, kinases, and phosphodiesterases.
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
Nova Biologicals implemented a Thermo Scientific LIMS integrated with NextDocs DMS to replace their outdated paper-based and manual processes, allowing them to more efficiently manage their increasing sample load and meet growing regulatory requirements from organizations like the FDA and EPA. The new system automated workflows, improved data quality and access, enhanced reporting capabilities, and facilitated regulatory compliance audits. Nova has seen benefits including increased throughput, personnel cost savings, improved customer service, and ease of meeting accreditation standards.
Unlocking Productivity: Leveraging the Potential of Copilot in Microsoft 365, a presentation by Christoforos Vlachos, Senior Solutions Manager – Modern Workplace, Uni Systems
This file includes the SLAS2013 presentations of Paul A. Johnston of University of Pittsburgh; Douglas Auld of Novartis Institutes for Biomedical Research; and Lisa Minor of In Vitro Strategies, LLC.
Innovative Drug Pipeline Solutions: Medicinal Chemistry, Process Chemistry, cGMP API Manufacturing. 105+ global clients. 120,000 sq.ft. facilities located in Research Triangle Park, NC USA. FDA inspected and DEA registered.
Persistent has expertise in developing software and drivers for multiple analytical instruments including LC, GC, MS, PCR, bioinformatics, NGS, CE, and flow cytometry. They have over 20 years of experience producing chromatography software and over 15 years of experience developing instrument drivers for various systems. Persistent also has an in-house laboratory for development and testing.
CoreRx is a dosage form development company specializing in formulation development, analytical development, and clinical manufacturing. They focus on client satisfaction, quality science, strong communication, timeline management, and client goals. CoreRx offers preformulation, formulation development, analytical services, manufacturing, packaging, labeling, and stability services. They have experienced scientific staff and capabilities including specialized dosage forms. CoreRx aims to get clients' products to market quickly while maintaining compliance.
Describes the integrated use of several common analytical informatics tools / platforms in the lab and the VM space to maximize access. It also describes a variety of customized additions including links to proprietary databases, barcode utilization, adding value to analytical data, and one stop shopping for data analysis / reporting. The impact is that the same FTEs can produce >3 fold more results!
Sandor Szalma (Janssen) gives an overview of this potential Pistoia Alliance working group during the "Dragons' Den" session of the Pistoia Alliance Conference in Boston, MA, on April 24, 2012.
Appalla Venkataprabhakar and I presented this at the Oracle\'s Annual Clinical Development and Safety Conference 2010 at Hyderabad, India on 6th October 2010.
Luke Lightning presented on pre-clinical drug development and ADME (absorption, distribution, metabolism, excretion) studies. He discussed why ADME is important for assessing a compound's developability. He provided examples of his experience conducting ADME studies at Alquest Therapeutics and a previous company. The presentation covered regulatory considerations for ADME studies, in vitro and in vivo study types and costs, and options for conducting studies in-house or outsourcing them. An example ADME work plan was presented, along with a summary of key points and future directions for ADME research.
The document is a resume for Kanagasabapathi S., highlighting his expertise and 10+ years of experience in bioanalytical method development and drug discovery. It summarizes his responsibilities developing over 1000 analytical methods for small molecules, conducting ADME assays, and managing projects. Currently he works as a Research Scientist at Syngene International Ltd, where he leads projects and trains junior scientists.
The SCYNEXIS analytical research and development team consists of experienced scientists who develop and validate analytical methods for starting materials, active pharmaceutical ingredients, and synthetic intermediates according to regulatory guidance documents. SCYNEXIS has state-of-the-art instrumentation and the expertise to solve complex analytical problems and meet aggressive timelines. Their services include method development and validation, assay testing, forced degradation studies, and structural identification.
The Genome-in-a-Bottle Consortium aims to develop reference materials for clinical applications of human genome sequencing. The National Institute of Standards and Technology is partnering with the Food and Drug Administration and other organizations to produce reference genomes that can be used to evaluate the performance of sequencing instruments and ensure consistency across platforms. The consortium will select candidate reference genomes, experimentally characterize the materials, integrate the data to produce consensus variant calls, and define performance metrics for end users. The goal is to provide a trusted source of reference materials to support regulatory oversight and commercial use of genome sequencing.
This document summarizes information about Novo Informatics, a drug discovery startup incubated at IIT Delhi. It provides an overview of computational aided drug design (CADD) and its advantages. Novo Informatics' mission is to accelerate drug discovery through CADD approaches like virtual screening and hit optimization. It has expertise in various areas of the drug discovery process and access to chemical libraries and supercomputing facilities at IIT Delhi. The company also engages in target analysis, molecule synthesis and validation services for clients.
Pete Young is an analytical scientist with over 25 years of experience in GMP and non-GMP analytical chemistry laboratory environments at Eli Lilly and Company. He has extensive experience operating and maintaining laboratory equipment, developing analytical methods, and analyzing samples using techniques such as HPLC, GC, Karl Fischer, UV-Vis, and dissolution. Pete is proficient with various computer programs for data management and reporting. He enjoys working independently while also collaborating as part of a team. Pete is safety-conscious and always looking for ways to improve work processes.
The document discusses process improvement metrics and methods at the Jet Propulsion Laboratory (JPL). It notes that while JPL aims to perform like a CMMI Level 4 organization, it is actually assessed at CMMI Level 3. It outlines some of JPL's data collection methods and key questions around understanding their software environment. Some of the processes in place include tailoring software development processes and measuring performance against processes. Risks, strengths and recommendations are identified from process reviews.
Dear Sir,
I take pleasure in introducing STABICON LIFE SCIENCES, a focused Analytical Methods Development/Validation & Stability Centre.
Stabicon Life Sciences is a Contract Research Organization. Services provided by Stabicon currently include specialized and focused services for complete stability study management including storage of samples, analysis and preparation of required documentation, associated analytical method development and validations for different phases of drug development program.
We are committed to complete confidentiality and protection of client’s intellectual property. We are committed to quality and reliability of our service. We also remain committed to our customers to deliver on agreed objectives and committed timelines and a promise to ourselves to be a reliable partner fulfilling requirements of our customer’s .Now we have been approved by few National & Multinational companies, who have now placed order with us for conducting stability studies on their products. We have been audited on behalf of Health Canada and have been approved for performing analytical and stability work for Canadian companies. We are also in process getting registration of our company with USFDA as cGMP testing analytical company located outside United States.
We have come across your company as a reputed organisation.We are looking for business partners with whom we can associate by acting as your back office support from India. By doing this it will allow you to allocate your resources for strategic projects. It will also allow you to save on your budgets significantly by taking advantage of Indian costs with International Quality Services offered by Stabicon.You may please visit our website www.stabicon.com for more details.
Looking forward to your response.
Thanking you and assuring our best service at all time.
Regards,
Vijay
Project Director
Stabicon Life Sciences Pvt Ltd
Mobile: +919591974355/080-41714280
www.stabicon.com
This document provides an overview of Stabicon Life Sciences, an analytical testing laboratory located in Bangalore, India. It describes the facility's 15,000 square foot built area, cGMP and cGLP compliance, and management by experienced professionals. Services offered include stability programs, analytical development and validation, bio-waiver studies, quality control testing, and microbiological testing.
Dilip Shah is seeking a position in pharmaceutical research utilizing his skills in laboratory instrumentation and assays. He has over 15 years of experience in compound management, high-throughput screening, and assay operations at major pharmaceutical companies. His technical skills include automated liquid handling systems, fluorescence and luminescence detection instruments, and assay techniques for targets such as ion channels, kinases, and phosphodiesterases.
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
Nova Biologicals implemented a Thermo Scientific LIMS integrated with NextDocs DMS to replace their outdated paper-based and manual processes, allowing them to more efficiently manage their increasing sample load and meet growing regulatory requirements from organizations like the FDA and EPA. The new system automated workflows, improved data quality and access, enhanced reporting capabilities, and facilitated regulatory compliance audits. Nova has seen benefits including increased throughput, personnel cost savings, improved customer service, and ease of meeting accreditation standards.
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