Kavin Sandron has over 3 years of experience in software testing. He has expertise in test design, execution, defect management and various types of testing including functional, report, and mobile testing. He is proficient in testing methodologies and has worked on multiple projects for clients in the life sciences domain. Kavin is looking for new opportunities to grow his career and learn.
Enhance Learning Efficiency in LIfe Sciences with Industry-Leading Learning C...Veeva Systems
See how an end-to-end solution enables customers to modernize training while streamlining resources and improving learning outcomes. Join us to learn how combining best-in-class training content and LMS technology improves efficiency and brings strategic value to your organization.
Join this session to learn:
How adding a standard GxP content library to your LMS increases training efficiency
The best place to start with eLearning content
Scaling your use of a GxP training library based on organizational maturity
Partnering with Veeva for your ongoing learning strategy needs
Veeva Systems Webinar: Driving Continuous Quality ImprovementsVeeva Systems
Watch the on-demand webinar here: https://go.veeva.com/driving-continuous-quality-improvements/on-demand
Building a strong foundation to drive continuous quality improvements requires connecting people, processes, and technology. Life sciences companies transforming quality management with this holistic approach have increased quality management efficiency by up to 50% and reduced paperwork by 90%.
Watch the webinar and learn how you can create such a foundation for your organization on an intelligent, data-driven, end-to-end digital platform. You will also hear real-world use cases of applying advanced technologies like AI to enable proactive quality management across all operational areas.
You will hear:
- Opportunities and recommendations to unify and streamline quality systems and processes
- Areas where modern-era technologies like cloud and AI can increase efficiency, optimize cost, and bring products to patients faster
- Real-world examples of how leading organizations are transforming quality management to drive continuous quality improvements.
Streamline Change Control and Variation ManagementVeeva Systems
To watch a recording of this webinar, please visit: https://go.veeva.com/changecontrol_2020
Change control is a complex, multi-step process that requires collaboration across various teams within an organization.
Each year, biopharma companies evaluate hundreds of changes to approved products, many of which have a regulatory impact. Attempting to manage these touchpoints through manual processes can lead to incomplete information, massive distribution delays, and issues with regulatory compliance.
Watch this webinar to hear how Veeva is streamlining change control and variation management for greater transparency and improved decision making.
By attending you will:
- Learn the value of unifying disconnected business processes
- See how streamlining change control improves decision making and lowers risks
Ashley Wentworth, Director of Strategy for Vault Quality, and Marc Gabriel, Sr. Director of Vault RIM, will review the challenges associated with managing these processes and explain how a unified Quality and Regulatory solution automates information exchange across business functions.
Using Vault eTMF Milestones and EDLs to Support Inspection ReadinessVeeva Systems
Hear how Daiichi Sankyo is using milestones and expected document lists (EDLs) to enable ongoing inspection readiness and proactive TMF management and oversight.
This presentation reviews the regulatory requirements for intended use validation of SaaS-based EDC systems from the Sponsor and CRO perspective and provides best practices for implementing the proper validation in your organization.
Webinar: Rethinking the Life Sciences Training Technology EcosystemVeeva Systems
Watch the full webinar here: https://go.veeva.com/training-ecosystem-2021
As a training steward, you are required to select the right systems to enable an effective and efficient training program for your organization. But the task is easier said than done due to an increasingly complex technology landscape.
Join Kent Malmros, Sr. Director of Veeva Vault Training, to learn about different training technologies available today and how they fit together to create an optimal learning environment for both administrators and learners. You will also learn about technologies you won't need, reducing the cost and complexity of your training environment.
In this one hour webinar, you will learn:
Key definitions and descriptions of modern training technology categories
How to prioritize acquiring new job technologies and eliminating legacy solutions
Best practices for effectively connecting systems and processes to ensure faster time to qualification and competency
We will also have a deep dive discussion into:
Authoring tools
Document and Content Management Systems
Learning Management Systems
Gamification Frameworks
Learning Experience Platforms
Immunomedics: Transforming TMF OperationsVeeva Systems
Immunomedics discusses how they achieved best-in-class TMF management and outlines steps for improving cross-functional ownership and collaboration with CRO partners.
To learn more best practices and see how organizations like Allakos, Daiichi Sankyo, and GBT maintain inspection readiness, visit this resources page: https://bit.ly/Inspection-Readiness
Enhance Learning Efficiency in LIfe Sciences with Industry-Leading Learning C...Veeva Systems
See how an end-to-end solution enables customers to modernize training while streamlining resources and improving learning outcomes. Join us to learn how combining best-in-class training content and LMS technology improves efficiency and brings strategic value to your organization.
Join this session to learn:
How adding a standard GxP content library to your LMS increases training efficiency
The best place to start with eLearning content
Scaling your use of a GxP training library based on organizational maturity
Partnering with Veeva for your ongoing learning strategy needs
Veeva Systems Webinar: Driving Continuous Quality ImprovementsVeeva Systems
Watch the on-demand webinar here: https://go.veeva.com/driving-continuous-quality-improvements/on-demand
Building a strong foundation to drive continuous quality improvements requires connecting people, processes, and technology. Life sciences companies transforming quality management with this holistic approach have increased quality management efficiency by up to 50% and reduced paperwork by 90%.
Watch the webinar and learn how you can create such a foundation for your organization on an intelligent, data-driven, end-to-end digital platform. You will also hear real-world use cases of applying advanced technologies like AI to enable proactive quality management across all operational areas.
You will hear:
- Opportunities and recommendations to unify and streamline quality systems and processes
- Areas where modern-era technologies like cloud and AI can increase efficiency, optimize cost, and bring products to patients faster
- Real-world examples of how leading organizations are transforming quality management to drive continuous quality improvements.
Streamline Change Control and Variation ManagementVeeva Systems
To watch a recording of this webinar, please visit: https://go.veeva.com/changecontrol_2020
Change control is a complex, multi-step process that requires collaboration across various teams within an organization.
Each year, biopharma companies evaluate hundreds of changes to approved products, many of which have a regulatory impact. Attempting to manage these touchpoints through manual processes can lead to incomplete information, massive distribution delays, and issues with regulatory compliance.
Watch this webinar to hear how Veeva is streamlining change control and variation management for greater transparency and improved decision making.
By attending you will:
- Learn the value of unifying disconnected business processes
- See how streamlining change control improves decision making and lowers risks
Ashley Wentworth, Director of Strategy for Vault Quality, and Marc Gabriel, Sr. Director of Vault RIM, will review the challenges associated with managing these processes and explain how a unified Quality and Regulatory solution automates information exchange across business functions.
Using Vault eTMF Milestones and EDLs to Support Inspection ReadinessVeeva Systems
Hear how Daiichi Sankyo is using milestones and expected document lists (EDLs) to enable ongoing inspection readiness and proactive TMF management and oversight.
This presentation reviews the regulatory requirements for intended use validation of SaaS-based EDC systems from the Sponsor and CRO perspective and provides best practices for implementing the proper validation in your organization.
Webinar: Rethinking the Life Sciences Training Technology EcosystemVeeva Systems
Watch the full webinar here: https://go.veeva.com/training-ecosystem-2021
As a training steward, you are required to select the right systems to enable an effective and efficient training program for your organization. But the task is easier said than done due to an increasingly complex technology landscape.
Join Kent Malmros, Sr. Director of Veeva Vault Training, to learn about different training technologies available today and how they fit together to create an optimal learning environment for both administrators and learners. You will also learn about technologies you won't need, reducing the cost and complexity of your training environment.
In this one hour webinar, you will learn:
Key definitions and descriptions of modern training technology categories
How to prioritize acquiring new job technologies and eliminating legacy solutions
Best practices for effectively connecting systems and processes to ensure faster time to qualification and competency
We will also have a deep dive discussion into:
Authoring tools
Document and Content Management Systems
Learning Management Systems
Gamification Frameworks
Learning Experience Platforms
Immunomedics: Transforming TMF OperationsVeeva Systems
Immunomedics discusses how they achieved best-in-class TMF management and outlines steps for improving cross-functional ownership and collaboration with CRO partners.
To learn more best practices and see how organizations like Allakos, Daiichi Sankyo, and GBT maintain inspection readiness, visit this resources page: https://bit.ly/Inspection-Readiness
Enabling Proactive Quality Management Across Quality and ManufacturingVeeva Systems
Imagine a quality system that allows you to predict and address quality issues before they occur, increase efficiency through intelligent automation, and increase visibility and collaboration across the supply chain.
Today more than 450 pharma, biotech, medtech, and contract services have turned this vision into reality by redesigning their legacy processes and modernizing their quality infrastructure. Using industry best practices and a strong technology foundation, they standardized business processes across GxPs and unified and connected quality and manufacturing systems for speed and efficiency.
In this presentation, you will learn:
- How digital transformation enables companies to pursue quality excellence
- Opportunities to unify and streamline systems and processes
- Best practices from leading companies to enable proactive quality management
Micro-learning, Macro-compliance: Improving GxP Compliance with Modern Learni...Veeva Systems
Watch the webinar: https://go.veeva.com/microlearning-ondemand
Micro-learning, Macro-Compliance: Improving GxP Compliance with Modern Learning Techniques
Today's fast-paced and increasingly virtual world is challenging life sciences companies to apply modern learning practices like micro-learning for both GxP and non-GxP training requirements.
While micro-learning has taken the learning and development world by storm, there are still misconceptions about what it is and how to incorporate it into an existing training strategy.
John Constantine, SVP of Talent Solutions at Orchestrall Inc., and Kent Malmros, Senior Director of Vault Training at Veeva Systems, team up to discuss the benefits of micro-learning and a practical approach to applying it into your existing GXP training program.
Join this webinar to learn:
- About micro-learning and how it can boost your GxP training compliance
- How to overcome the common misconceptions about micro-learning
- How to implement micro-learning into your GxP training program
Who Will Benefit:
- Director/Manager of Quality Training
- Compliance Training Manager/Director
- Compliance Policy and Training, Manager/Director
- Director/Manager, QA Training
- Document Control and Training Manager
- VP/Director of Quality and Compliance (QA or QC), Quality Systems
- VP/Director of Information Technology, Quality Management Systems, Quality Systems
- VP/Director of Clinical Operations
Best practices for implementing and maintaining successful standardsVeeva Systems
Watch the video here: https://bit.ly/3uvar1u
This webinar provides best practices, check-lists and case studies for leveraging standards in clinical trials. From creation and implementation, to governance tools (both internal and with external partners), attendees walk away with actionable insights to leverage with their own organization.
* Understand what to standardize
* Learn several approaches to standards development and when they make sense
* Ensure alignment with key stakeholders
* Maintain and govern standards over time
* Reduce overall configuration time
Who Will Benefit:
* Clinical Data (manager/director/head of) Clinical ops
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
* Data standards
* Quantitative sciences
* Informatics
* Data monitoring
* Clinical leads
* Study managers
* Clinical study
* Data manager
* CRA
* CDISC
Meet Your Presenters:
Carla Reis
Director, Client Services, 4G Clinical
Carla Reis, Director of Client Services at 4G Clinical, has over 18 years of experience as an operational leader in developing and implementing RTSM systems in a global pharmaceutical company. Carla was a leader in her organization in establishing vendor management standards and processes. She has helped lead major RTSM process improvement initiatives where she established new and innovated approaches to drug assignment verification and vendor integrations. Carla has presented at industry conferences as a subject matter expert on best practices using RTSM solutions for complex strategies in supply chain management. Carla holds a BS in Neurobiology and Physiology from the University of Connecticut and a certification as Lean Six Sigma Yellow Belt. Carla also holds a Masters in Science in Health Administration with a concentration in Health Informatics from Saint Joseph's University.
Paul MacDonald
Senior Director, Strategy Vault CDMS, Veeva Systems
Paul is Senior Director Vault CDMS, responsible for strategy and direction in data management. With 25+ years experience working in life science at pharma, CRO and technology organisations, Paul brings a strong operational focus in relation to eClinical technology for data management and clinical operations that stretches from EDC, through CTMS to risk based monitoring.
How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDCVeeva Systems
Watch the video here: https://bit.ly/3urhVSi
CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management. They’ll share insights into how to:
* Build a database from standards and your protocol (not a spec)
* Replace manual documentation with system-generated reports
* Provide real-time visibility into the status of data collection and cleaning
Hear their first-hand accounts of adopting an Agile Design methodology with Veeva Vault CDMS and reaping the rewards of a straightforward build and a modern EDC.
Simplifying Postmarket Surveillance: Introducing Veeva Vault Product Surveill...Eric Burniche, MBA
To watch the full webinar:
The growing complexity of medical products and rapidly changing global regulations require a more holistic and consistent approach to postmarket surveillance (PMS).
However, disconnected and highly-customized solutions - historically serving med-tech companies - have fallen short of meeting the evolving needs of the industry.
Can your PMS system quickly adapt to regulatory changes and enable you to meet global submission timelines?
In this webinar, Carl Ning, Sr Director of Strategy at Veeva systems, discusses recent trends driving organizations to transform systems and processes for better product quality and reliability. You will also hear about Veeva Vault Product Surveillance, Veeva’s new application that simplifies and standardizes global postmarket surveillance.
Attend the webinar to learn:
- How to address common challenges in managing complaints and submissions
- How a unified approach to postmarket surveillance streamlines end-to-end quality management
- How Vault Product Surveillance standardizes and consolidates the complaint reportability process for various health authorities
Efficient Trial Management through Unified CTMS and Study Start-upVeeva Systems
Learn the benefits of a unified clinical landscape, particularly how clinical trial management software (CTMS) and study start-up applications lead to more efficient trial management when working in concert with one another.
Driving Clinical Trial Efficiency in an Outsourced ModelVeeva Systems
Explore how a unified operating environment increases operational efficiency, simplifies trial collaboration, and improves study quality in an outsourced model. Slides from Veeva's session at 2019 Outsourcing in Clinical Trials West Coast.
Speed Clinical Trials from Start to Close: The Path to a Modern CTMSVeeva Systems
Learn how a modern CTMS leads to better oversight, study analytics, and risk identification. This presentation also covers common barriers to the migration process and how to overcome them. Watch a demonstration of Veeva Vault CTMS: http://bit.ly/VaultCTMSDemo
GSK: Preparing the Business for Study Start-up ChangeVeeva Systems
At the 2020 Veeva R&D and Quality Summit, GSK detailed their journey to transform study start-up. See their presentation slides for practical advice on gaining stakeholder alignment, issue resolution, and best practices to institute governance around a unified clinical program.
Watch on-demand: https://www.veeva.com/events/rd-summit/presentations/
Unify quality manufacturing to drive speed, compliance and collaborationVeeva Systems
Whether you are an emerging CDMO looking to scale and attract sponsors or an established generics org looking to transform legacy systems, there is an approach to consider! Learn how you can drive efficiency, collaboration, and compliance and how to get started in unifying your quality manufacturing processes.
Vertex Reduces EDC Study Build Times by 50%Veeva Systems
Watch the video here: https://bit.ly/3oUi6Vg
The clinical data team at Vertex asked themselves, how can we reduce our development timelines and costs—make things go faster, for less?
Answering those questions set Vertex on a path to challenge themselves and their vendors to improve speed without sacrificing quality. As a result, they’re reducing database build times by as much as 50% and reliably lock data in 15-18 days.
This webinar covers:
* How Vertex reaches 80-90% compliance with sites entering data within 2 days of the event
* Their #1 goal for transforming the UAT process
* Their novel recommendation for when to go live
* The technology strategy supporting their process improvements
Who Will Benefit:
* Clinical data executives
* Heads of clinical
* Heads of clinical research
Meet Your Presenters:
Vikas Gulati
Senior Director of Clinical Data Management and Metrics, Vertex Pharmaceuticals
Vikas Gulati has over 20 years’ experience focused on clinical data management, data standards and governance. He has led several global cross-functional teams to successful outcomes in Biotech/Pharma and CROs. He is currently the Global Head of Clinical Data Management at Vertex Pharmaceuticals, Inc.
Richard Young
Vice President, Vault EDC, Veeva Systems
Richard Young has nearly 25 years of expertise in data management, clinical solutions, and advanced clinical strategies. At Veeva, Young is establishing Vault EDC as the leading solution for clinical data management.
Michelle Harrison
Associate Director of Clinical Data Management and Metrics, Vertex
Michelle Harrison is currently working at Vertex Pharmaceutical in Boston Massachusetts as an Associate Director of Data Management. Prior to joining Vertex, she worked as a consultant for BioBridges. For 2 years there she consulted for a number of small Biotechs assisting with Vendor oversight and start up activities.
Apellis Pharmaceuticals Selects a Modern Safety SolutionVeeva Systems
Apellis Pharmaceuticals shares evaluation criteria for a pharmacovigilance system and why they chose a modern safety solution. Watch the on-demand webinar to learn more: http://bit.ly/374MdP8
Transform Your Digital Content to Improve Speed to Market While Maintaining C...Veeva Systems
Watch the full webinar to learn industry challenges and how Roche Diagnostics is transforming its digital content management with Veeva Vault PromoMats to improve speed to market:
https://go.veeva.com//transform-content-management-to-improve-speed-to-market
By better managing the lifecycle of digital assets, it will be possible to reduce expensive duplication of assets, maintain control of the brand image, and stay compliant in a complex regulatory environment.
Demystifying cloud system and validation practices for life sciencesVeeva Systems
Watch the on-demand recording here: bit.ly/GxPValidationwithCloud
Cloud-based regulated systems greatly accelerate the GxP validation process, improving IT efficiency. By performing and documenting the installation qualification (IQ) and operational qualification (OQ) procedures, modern cloud applications ease the validation burden on IT teams and speed validation process.
However, common misconceptions about the cloud prevent IT teams from taking advantage of a faster and better validation process.
During this webinar, "Demystifying Cloud Systems and Validation Best Practices for Life Sciences", we discuss this topic and with PricewaterhouseCoopers (PwC). By watching, you will learn GxP validation best practices in a cloud environment and gain insights into:
- How to evaluate various types of cloud-based quality systems
- How traditional vs. cloud validation approaches impact your business
- How to apply a tactical framework to validation
Webinar: Driving Operational Agility with Digital Quality ManagementVeeva Systems
Watch the webinar here: https://go.veeva.com/Driving-Operational-Agility_webinar
This presentation is from a Veeva Systems Quality Team webinar series hosted by Contract Pharma.
Is the disconnected technology landscape slowing down operations and draining resources?
New-market demands, increasingly complex supply chains, and changing regulations will continue as the norm. Modern technologies can help manufacturers manage these external forces effectively, enabling them to be more agile, data-driven, and future-ready.
Today many manufacturers are digitizing quality management to increase operational agility and supply chain collaboration, meeting continually-changing market and customer demands.
Join Veeva experts in this webinar to learn how digitalizing quality management bridges gaps between manufacturing and quality management, improving cycle times and agility.
In this webinar, you will learn:
- About the opportunities to transform quality management
- How the right technology streamlines global quality processes, increasing automation and operational agility
- The industry best practices for driving successful digital transformation
J&J: Transforming Study Start-up in a Global Environment Veeva Systems
In this presentation, Lisa Rakebrand, Director Clinical R&D at J&J, discusses her team's vision to transform the way study start-up is conducted globally by leveraging Vault Study Startup to improve site collaboration, streamline site activation, and speed study start-up.
Practical Strategies for Taking on New Studies Post COVID-19Veeva Systems
Hear expert guidance for ensuring readiness when opening your doors and making data-driven, evidence-based decisions on which studies to accept post COVID-19.
Shorten Database Builds by 60% with Agile DesignVeeva Systems
Watch the video here: https://bit.ly/3f64wJZ
See the Packed #SCDM2019 Session
Radical time savings aren’t possible with incremental process improvements. An agile EDC enables process transformation that shortens database builds by 40-60%. Join a live webinar of the packed SCDM product showcase to hear the technologies and processes behind those savings, including real-time UAT, data-driven rules and dynamics, and easy amendments.
Enabling Proactive Quality Management Across Quality and ManufacturingVeeva Systems
Imagine a quality system that allows you to predict and address quality issues before they occur, increase efficiency through intelligent automation, and increase visibility and collaboration across the supply chain.
Today more than 450 pharma, biotech, medtech, and contract services have turned this vision into reality by redesigning their legacy processes and modernizing their quality infrastructure. Using industry best practices and a strong technology foundation, they standardized business processes across GxPs and unified and connected quality and manufacturing systems for speed and efficiency.
In this presentation, you will learn:
- How digital transformation enables companies to pursue quality excellence
- Opportunities to unify and streamline systems and processes
- Best practices from leading companies to enable proactive quality management
Micro-learning, Macro-compliance: Improving GxP Compliance with Modern Learni...Veeva Systems
Watch the webinar: https://go.veeva.com/microlearning-ondemand
Micro-learning, Macro-Compliance: Improving GxP Compliance with Modern Learning Techniques
Today's fast-paced and increasingly virtual world is challenging life sciences companies to apply modern learning practices like micro-learning for both GxP and non-GxP training requirements.
While micro-learning has taken the learning and development world by storm, there are still misconceptions about what it is and how to incorporate it into an existing training strategy.
John Constantine, SVP of Talent Solutions at Orchestrall Inc., and Kent Malmros, Senior Director of Vault Training at Veeva Systems, team up to discuss the benefits of micro-learning and a practical approach to applying it into your existing GXP training program.
Join this webinar to learn:
- About micro-learning and how it can boost your GxP training compliance
- How to overcome the common misconceptions about micro-learning
- How to implement micro-learning into your GxP training program
Who Will Benefit:
- Director/Manager of Quality Training
- Compliance Training Manager/Director
- Compliance Policy and Training, Manager/Director
- Director/Manager, QA Training
- Document Control and Training Manager
- VP/Director of Quality and Compliance (QA or QC), Quality Systems
- VP/Director of Information Technology, Quality Management Systems, Quality Systems
- VP/Director of Clinical Operations
Best practices for implementing and maintaining successful standardsVeeva Systems
Watch the video here: https://bit.ly/3uvar1u
This webinar provides best practices, check-lists and case studies for leveraging standards in clinical trials. From creation and implementation, to governance tools (both internal and with external partners), attendees walk away with actionable insights to leverage with their own organization.
* Understand what to standardize
* Learn several approaches to standards development and when they make sense
* Ensure alignment with key stakeholders
* Maintain and govern standards over time
* Reduce overall configuration time
Who Will Benefit:
* Clinical Data (manager/director/head of) Clinical ops
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
* Data standards
* Quantitative sciences
* Informatics
* Data monitoring
* Clinical leads
* Study managers
* Clinical study
* Data manager
* CRA
* CDISC
Meet Your Presenters:
Carla Reis
Director, Client Services, 4G Clinical
Carla Reis, Director of Client Services at 4G Clinical, has over 18 years of experience as an operational leader in developing and implementing RTSM systems in a global pharmaceutical company. Carla was a leader in her organization in establishing vendor management standards and processes. She has helped lead major RTSM process improvement initiatives where she established new and innovated approaches to drug assignment verification and vendor integrations. Carla has presented at industry conferences as a subject matter expert on best practices using RTSM solutions for complex strategies in supply chain management. Carla holds a BS in Neurobiology and Physiology from the University of Connecticut and a certification as Lean Six Sigma Yellow Belt. Carla also holds a Masters in Science in Health Administration with a concentration in Health Informatics from Saint Joseph's University.
Paul MacDonald
Senior Director, Strategy Vault CDMS, Veeva Systems
Paul is Senior Director Vault CDMS, responsible for strategy and direction in data management. With 25+ years experience working in life science at pharma, CRO and technology organisations, Paul brings a strong operational focus in relation to eClinical technology for data management and clinical operations that stretches from EDC, through CTMS to risk based monitoring.
How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDCVeeva Systems
Watch the video here: https://bit.ly/3urhVSi
CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management. They’ll share insights into how to:
* Build a database from standards and your protocol (not a spec)
* Replace manual documentation with system-generated reports
* Provide real-time visibility into the status of data collection and cleaning
Hear their first-hand accounts of adopting an Agile Design methodology with Veeva Vault CDMS and reaping the rewards of a straightforward build and a modern EDC.
Simplifying Postmarket Surveillance: Introducing Veeva Vault Product Surveill...Eric Burniche, MBA
To watch the full webinar:
The growing complexity of medical products and rapidly changing global regulations require a more holistic and consistent approach to postmarket surveillance (PMS).
However, disconnected and highly-customized solutions - historically serving med-tech companies - have fallen short of meeting the evolving needs of the industry.
Can your PMS system quickly adapt to regulatory changes and enable you to meet global submission timelines?
In this webinar, Carl Ning, Sr Director of Strategy at Veeva systems, discusses recent trends driving organizations to transform systems and processes for better product quality and reliability. You will also hear about Veeva Vault Product Surveillance, Veeva’s new application that simplifies and standardizes global postmarket surveillance.
Attend the webinar to learn:
- How to address common challenges in managing complaints and submissions
- How a unified approach to postmarket surveillance streamlines end-to-end quality management
- How Vault Product Surveillance standardizes and consolidates the complaint reportability process for various health authorities
Efficient Trial Management through Unified CTMS and Study Start-upVeeva Systems
Learn the benefits of a unified clinical landscape, particularly how clinical trial management software (CTMS) and study start-up applications lead to more efficient trial management when working in concert with one another.
Driving Clinical Trial Efficiency in an Outsourced ModelVeeva Systems
Explore how a unified operating environment increases operational efficiency, simplifies trial collaboration, and improves study quality in an outsourced model. Slides from Veeva's session at 2019 Outsourcing in Clinical Trials West Coast.
Speed Clinical Trials from Start to Close: The Path to a Modern CTMSVeeva Systems
Learn how a modern CTMS leads to better oversight, study analytics, and risk identification. This presentation also covers common barriers to the migration process and how to overcome them. Watch a demonstration of Veeva Vault CTMS: http://bit.ly/VaultCTMSDemo
GSK: Preparing the Business for Study Start-up ChangeVeeva Systems
At the 2020 Veeva R&D and Quality Summit, GSK detailed their journey to transform study start-up. See their presentation slides for practical advice on gaining stakeholder alignment, issue resolution, and best practices to institute governance around a unified clinical program.
Watch on-demand: https://www.veeva.com/events/rd-summit/presentations/
Unify quality manufacturing to drive speed, compliance and collaborationVeeva Systems
Whether you are an emerging CDMO looking to scale and attract sponsors or an established generics org looking to transform legacy systems, there is an approach to consider! Learn how you can drive efficiency, collaboration, and compliance and how to get started in unifying your quality manufacturing processes.
Vertex Reduces EDC Study Build Times by 50%Veeva Systems
Watch the video here: https://bit.ly/3oUi6Vg
The clinical data team at Vertex asked themselves, how can we reduce our development timelines and costs—make things go faster, for less?
Answering those questions set Vertex on a path to challenge themselves and their vendors to improve speed without sacrificing quality. As a result, they’re reducing database build times by as much as 50% and reliably lock data in 15-18 days.
This webinar covers:
* How Vertex reaches 80-90% compliance with sites entering data within 2 days of the event
* Their #1 goal for transforming the UAT process
* Their novel recommendation for when to go live
* The technology strategy supporting their process improvements
Who Will Benefit:
* Clinical data executives
* Heads of clinical
* Heads of clinical research
Meet Your Presenters:
Vikas Gulati
Senior Director of Clinical Data Management and Metrics, Vertex Pharmaceuticals
Vikas Gulati has over 20 years’ experience focused on clinical data management, data standards and governance. He has led several global cross-functional teams to successful outcomes in Biotech/Pharma and CROs. He is currently the Global Head of Clinical Data Management at Vertex Pharmaceuticals, Inc.
Richard Young
Vice President, Vault EDC, Veeva Systems
Richard Young has nearly 25 years of expertise in data management, clinical solutions, and advanced clinical strategies. At Veeva, Young is establishing Vault EDC as the leading solution for clinical data management.
Michelle Harrison
Associate Director of Clinical Data Management and Metrics, Vertex
Michelle Harrison is currently working at Vertex Pharmaceutical in Boston Massachusetts as an Associate Director of Data Management. Prior to joining Vertex, she worked as a consultant for BioBridges. For 2 years there she consulted for a number of small Biotechs assisting with Vendor oversight and start up activities.
Apellis Pharmaceuticals Selects a Modern Safety SolutionVeeva Systems
Apellis Pharmaceuticals shares evaluation criteria for a pharmacovigilance system and why they chose a modern safety solution. Watch the on-demand webinar to learn more: http://bit.ly/374MdP8
Transform Your Digital Content to Improve Speed to Market While Maintaining C...Veeva Systems
Watch the full webinar to learn industry challenges and how Roche Diagnostics is transforming its digital content management with Veeva Vault PromoMats to improve speed to market:
https://go.veeva.com//transform-content-management-to-improve-speed-to-market
By better managing the lifecycle of digital assets, it will be possible to reduce expensive duplication of assets, maintain control of the brand image, and stay compliant in a complex regulatory environment.
Demystifying cloud system and validation practices for life sciencesVeeva Systems
Watch the on-demand recording here: bit.ly/GxPValidationwithCloud
Cloud-based regulated systems greatly accelerate the GxP validation process, improving IT efficiency. By performing and documenting the installation qualification (IQ) and operational qualification (OQ) procedures, modern cloud applications ease the validation burden on IT teams and speed validation process.
However, common misconceptions about the cloud prevent IT teams from taking advantage of a faster and better validation process.
During this webinar, "Demystifying Cloud Systems and Validation Best Practices for Life Sciences", we discuss this topic and with PricewaterhouseCoopers (PwC). By watching, you will learn GxP validation best practices in a cloud environment and gain insights into:
- How to evaluate various types of cloud-based quality systems
- How traditional vs. cloud validation approaches impact your business
- How to apply a tactical framework to validation
Webinar: Driving Operational Agility with Digital Quality ManagementVeeva Systems
Watch the webinar here: https://go.veeva.com/Driving-Operational-Agility_webinar
This presentation is from a Veeva Systems Quality Team webinar series hosted by Contract Pharma.
Is the disconnected technology landscape slowing down operations and draining resources?
New-market demands, increasingly complex supply chains, and changing regulations will continue as the norm. Modern technologies can help manufacturers manage these external forces effectively, enabling them to be more agile, data-driven, and future-ready.
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J&J: Transforming Study Start-up in a Global Environment Veeva Systems
In this presentation, Lisa Rakebrand, Director Clinical R&D at J&J, discusses her team's vision to transform the way study start-up is conducted globally by leveraging Vault Study Startup to improve site collaboration, streamline site activation, and speed study start-up.
Practical Strategies for Taking on New Studies Post COVID-19Veeva Systems
Hear expert guidance for ensuring readiness when opening your doors and making data-driven, evidence-based decisions on which studies to accept post COVID-19.
Shorten Database Builds by 60% with Agile DesignVeeva Systems
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This comprehensive program covers essential aspects of performance marketing, growth strategies, and tactics, such as search engine optimization (SEO), pay-per-click (PPC) advertising, content marketing, social media marketing, and more
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Just a game Assignment 3
1. What has made Louis Vuitton's business model successful in the Japanese luxury market?
2. What are the opportunities and challenges for Louis Vuitton in Japan?
3. What are the specifics of the Japanese fashion luxury market?
4. How did Louis Vuitton enter into the Japanese market originally? What were the other entry strategies it adopted later to strengthen its presence?
5. Will Louis Vuitton have any new challenges arise due to the global financial crisis? How does it overcome the new challenges?Assignment 3
1. What has made Louis Vuitton's business model successful in the Japanese luxury market?
2. What are the opportunities and challenges for Louis Vuitton in Japan?
3. What are the specifics of the Japanese fashion luxury market?
4. How did Louis Vuitton enter into the Japanese market originally? What were the other entry strategies it adopted later to strengthen its presence?
5. Will Louis Vuitton have any new challenges arise due to the global financial crisis? How does it overcome the new challenges?Assignment 3
1. What has made Louis Vuitton's business model successful in the Japanese luxury market?
2. What are the opportunities and challenges for Louis Vuitton in Japan?
3. What are the specifics of the Japanese fashion luxury market?
4. How did Louis Vuitton enter into the Japanese market originally? What were the other entry strategies it adopted later to strengthen its presence?
5. Will Louis Vuitton have any new challenges arise due to the global financial crisis? How does it overcome the new challenges?
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1. Kavin Sandron NM
Programmer Analyst (Test Lead & Analyst) –3.2Years-Cognizant Technology Solutions, Chennai.
Graduated from Meenakshi Sundararajan Engg College,Chennai.
kavinsandronnm.msec@gmail.com +91 9677269824
A determined professional with over 3.2 years of experience in Information Technology field in the area of Software Testing -
Quality Assurance department under Life Sciences domain looking for a Best opportunity to learn and grow my Career along
with the organization
WORK EXPERIENCE Cognizant Technology Solutions- IT Service Providing Company
Programmer Analyst -Testing Services Nov 2011 to Dec 2014
Kavin Sandron has 3.2 years of experience in the field of Software Testing. As part of his
assignments, He has been in Requirement Analysis, Test Strategy, Test Planning, Test
design, Test Execution, Test Closure and Defect Management. Had worked as Test
Engineer/ Lead in the Projects. Possess expertise in Test Design and Test Execution for
Report Testing, Functional Testing, IPad Dashboard Testing, Mobile Testing, and Manual
Testing. He have worked in 8 Life Science projects for AstraZeneca Pharmaceuticals and
AMGEN Pharma Ltd.
KEYSKILLS
Software Testing
Validation Testing
- Functional Testing
Mobile Testing
Dashboard Testing
Report Testing
Defect Management
Profile Summary:
• Having 3.2 years of rich experience in functional testing across Web-based applications and in other testing projects.
• Domain knowledge in LifeSciences in Quality Engineeringand Assurance - Strong testingskills inLifeSciences
• ISTQB Certified Software Test Engineer.
• Experience in Quality Center(ALM) including development of Test Cases ,Defect Management and Test Execution.
• Solid understanding of QA Methodologies and Terminologies, with hands on experience in Functional Testing.
• Involved in Test Planning, Test design and Test execution and Test Closure process
• Have Good Working experience in Functional testing, Report Testing, IPad Dashboard Testing.
• Hands on experience in Web based Functional Testing.
• Experience in Defect Analysis and Defect Reporting
• Participated in all phases of STLC (software testing life cycle) including requirement analysis, testing, defect management, test
closure and documentation.
• Ability to work effectively and efficiently in team environment.
• Handled Individual Projects and Worked as Test Lead in the Projects
• Experience in managing medium size teams
• Passionate self-starter that works independently and Flexible, Consistent performer in the team.
2. Kavin Sandron NM
Programmer Analyst (Test Lead & Analyst) –3.2Years-Cognizant Technology Solutions, Chennai.
Graduated from Meenakshi Sundararajan Engg College,Chennai.
kavinsandronnm.msec@gmail.com +91 9677269824
Core Skills-Testing:
• Intensively involved in Software Testing Life Cycle model.
• Proficient in all cycles of Test life cycle from test planning to defect tracking and managing defect life cycle.
• Good exposure in Test Plan and Test Strategy, Proficient in Functional Testing.
• Expertise in Test Case Design, Test Execution, Defect Tracking and Defects Management.
• Have Rich experience in Mitigating Risk in the Projects such as doing Mitigation Plan document.
• Ensured that all scripts are traceable to specific business requirements
• Documented all results and supporting evidence for each test executed
• Adhere to Organization policies and procedures
• Proven experience in testing of Data/Server Migration systems
• Have Capability to Lead the Projects as Test lead as well as a Team Lead
• Experience in Handling the Projects Individually with Minimum Guidance.
PROJECTS UNDERTAKEN
AMGEN Pharma Ltd. TAS(TrainingAssignment Status) Dashboard Reporting
AstraZeneca PharmaceuticalsLtd. ASPEN Corrections Enhancement
AstraZeneca PharmaceuticalsLtd. AZ Canada POLO Enhancement
AstraZeneca PharmaceuticalsLtd. Aspen SunshineReporting
AstraZeneca PharmaceuticalsLtd. AZ AD Symphony DM & BI(Release2and 3)
AstraZeneca PharmaceuticalsLtd. Emerald Migration Programme (Middleware Migration )
AstraZeneca PharmaceuticalsLtd. Emerald Migration Programme(US Wave Migration)
AstraZeneca PharmaceuticalsLtd. Emerald CLINII (Clinical Information Infrastructure)
References
o Leo Xavier, Senior Associate- Cognizant Technology Solutions- Ph:9940294855- Mail:leoxraj@yahoo.com
o Sathya S , Senior Associate- Cognizant Technology Solutions- Ph:+1 8058073981-Mail:sathyarpt@yahoo.co.in
o Alexander, Associate - Cognizant Technology Solutions-Ph:9884551400- Mail:alex.joel@gmail.com
3. Kavin Sandron NM
Programmer Analyst (Test Lead & Analyst) –3.2Years-Cognizant Technology Solutions, Chennai.
Graduated from Meenakshi Sundararajan Engg College,Chennai.
kavinsandronnm.msec@gmail.com +91 9677269824
POSITIONS OF RESPONSIBILITIES
Industrial
Experience
Worked consecutively for 2 years as an Executive Member/Coordinator of the Event Management &
Team Building Committee of AstraZeneca Account 2011-2013
Received Best Associate of the Month Award for Notable Contributions to the Account
Worked as Treasurer for Fundooz Association at Cognizant Technology Solutions
Graduation
Member of the Electrical Technocrats Association (ETA) by the department for two consecutiveyears
(‘09-‘11) which was responsiblefor all thedepartmental student initiated activities.
Coordinated as a partof a team which framed the constitution for the stablefunctioningof the
Electrical
Technocrats Association (ETA).
Led the National Level department technical symposiumEPSILON– 2010 as its Member, which
was attended by over 1200 students across Tamil Nadu.Also Worked as Sponsorship Coordinator
for the Epsilon Symposiumevent.
Havebeen partof Team and successfully implemented protocol model of Wind Mill and
Transmission Overhead lines as a Project
Spearheaded a team which launched the firstdepartmental newsletter of the instituteand was
appointed as the Publisher of the bimonthly Newsletter of ETA.
Launched the Young Scientists Convention alongwith the team and ithas been a success
regularly inspiringstudents to be an activecontributor to the liveprojects since'2010.
Technical knowledge & Skills:
Operating Systems Windows XP, Windows Vista,Windows 7.
Databases Oracle,Netezza
Programming
Languages/Technology
C, OracleSQL.
Testing Methodologies Data Warehouse, ETL Testing [Extract TransformLoad], Report Testing, I Pad Dashboard Testing,
Validation Testing, System Testing, Functional Testing.Technologies used ETL[Extract TransformLoad]
Domain Expertise Life Sciences
Horizontal Testing Services
Tools Informatica 9.1.0,OracleSQL Developer 10.2.0 , Win SQL Professional,WinScp,Unix,MSTR,
SIMON,COGNOS reportingtool, BOBJ-Business Objects WeblinkCertifications CCP in Software Testing, CCP in L0 Life Sciences Testing, L0 and L1 Life sciences, CCP in L1 Validation,
CCP in MobiletestingTrainings AZ SDLC Trainings,AgileMethods, DR testing, ETLDW testing, MobileTesting – Practitioner,Testing
Metrics and Status ReportingExternal Certification Certified ISTQB Test Engineer-Completed ISTQB Certification in TestingDomain.
Education
2011 B.E.(EEE) Meenakshi Sundararajan EngineeringCollege,Anna University,Chennai 79%
2007 Class
XII
Jawahar Matriculation Higher Secondary school (Tamil Nadu) 85%
87%2005 Class
X
Jawahar Matriculation Higher Secondary school (Tamil Nadu) 80%
Areas of Expertise & Skill set
Manual Testing | Functional testing | Project Management | Life Sciences - Validation Testing
Personal Information
• Date of birth: 05 May, 1990
• Languages: English (RWS),Hindi (RW), Tamil (RWS)
• Address:No.22, U V Saminatha Iyer Salai, Neyveli-607803
4. Kavin Sandron NM
Programmer Analyst (Test Lead & Analyst) –3.2Years-Cognizant Technology Solutions, Chennai.
Graduated from Meenakshi Sundararajan Engg College,Chennai.
kavinsandronnm.msec@gmail.com +91 9677269824
PROJECT EXPERIENCE:
Client : AMGEN PHARMA LTD . Duration :May ’14 to July ‘14 (03 Months)
TAS Dashboard reporting
Project
Description
AMGEN has planned to Create a Training Assignment Status Reporting to provide a graphical and
dynamic tool which facilitates theease of assessmentof qualified staff by the FLM (Floor Line Manager)
before assigningstaff tasks to perform specific businessprocess.Thereports also providea quick way for
Managers to identify which staff have incomplete or unassigned trainingrequirements for specific task
as well as provides capability to drill-down to see details on which LearningActivities (LA) are not
complete in the overall assignment.
Databasetesting is carried outfor validatingthedata in the Dashboard againstthe Data in the COGNOS
Report used by Business users .The dashboard will bevalidated to ensure that the data displayed on the
report matches correspondingdata in the underlyingLMS Data Mart accordingto the Business.Data
validation is doneand ETL Testing is carried out to validatewhether the Target table fields arepopulated
with accuratedata from Source table.
Roles &
Responsibilities
Worked as Test Lead cum Test Analystin the project
Prepared Test Strategy/Approach document which included Testing scopeand entire Test Plan.
DW Test scriptpreparation and test artifacts preparation which includes
-Test Approach document, RTM Test scenarios,Test results,Defect and test logpreparation.
ETL Testing
ETL testing is done to ensure that the Data load is success fromSourceto Target database
Validation of Data is done for Data in TAS Dashboard report againstData in COGNOS Business Report.
Data validation is performed for Target data to ensure that Data is populated accurately from
Source database
to Target database Project Details
Role Test Lead and Test Engineer
Team Size 2
Software Platform Windows Vista
Hardware Platform Intel (R)
Tools ORACLE SQL DEVELOPER,BO REPORTING Web interface, COGNOS Reporting tool ,Quality center(ALM)
Type of testing
• Functional Testing
• ETL Testing
5. Kavin Sandron NM
Programmer Analyst (Test Lead & Analyst) –3.2Years-Cognizant Technology Solutions, Chennai.
Graduated from Meenakshi Sundararajan Engg College,Chennai.
kavinsandronnm.msec@gmail.com +91 9677269824
Client : ASTRAZENECA PHARMA LTD . Duration :Dec ’13 to Feb ‘14 (02 Months)
ASPEN Corrections Enhancement
Project
Description
The Corrections module of the ASPEN Admin application isbeingmodified to introduce a set of new
functionalities notincluded in the original release.The enhancements are mainly related to the
implementation of a new review-and-approval workflow(involvingcreation of separateroles for
creation,review and approval of transaction),reorganizingtheCorrections UI to regroup fields based on
user needs and in a manner consistentwith ADE, and updating the FileUpload functionality in
Corrections.
Corrections is one of the key modules in the ASPEN Admin application and is used primarily to correct
existing spend transactions and submit them back to TDM. The Corrections module also allows users to
create and submit new transactions to TDM.
Currently the Corrections module is not open to all users to access. The module is used only by a few
people. The review and approval of corrections is handled outside of the system manually by a CSI&R
reviewer, who is responsible for collecting correction transactions in excel files from source system
owners. In 2014, there are open payments expected to be received from different source systems and
this is expected to increase the number of corrections required. This requires the module to be opened
up to a larger number of users, allowing them to enter transactions on their own. However the system in
its current form cannot be opened up to all users, as the absence of a review/approval process might
cause erroneous transactions to be submitted to the TDM. Hence Corrections access is currently
restricted only to CSI&R team and is not open to all users who might need to create corrections.
Additionally, after the introduction of ADE (ASPEN Data Entry), there is a business need to modify the
Corrections user interface and make it consistent with ADE screens.
The project involves Testingof Application Functionality accordingto the Business Requirements. Testing
of Application involves such that Application works fine such a way that the enhancements works fine
with right flow of Business logic in the application
Roles &
Responsibilities
Test scriptpreparation and testartifacts preparation which includes
-Test Approach document, RTM Test scenarios,Testresults,Defect and test logpreparation.
Had Involved in Test Design, Test Execution and Defect Management Phases.
Functional Testingis done to ensure that the Application works fineand also the User can able to use
privileges accordingto the New Enhancement functionalities
Testing is done to check the Business flowprocess doneas per enhancement in the application
Project Details
Role Test Engineer/Analyst
Team Size 2
Software Platform Windows Vista
Hardware Platform Intel (R)
Type of testing
• Functional Testing
6. Kavin Sandron NM
Programmer Analyst (Test Lead & Analyst) –3.2Years-Cognizant Technology Solutions, Chennai.
Graduated from Meenakshi Sundararajan Engg College,Chennai.
kavinsandronnm.msec@gmail.com +91 9677269824
Client : ASTRAZENECA PHARMA LTD . Duration :Dec ’13 to Feb ‘14 (02 Months)
AZ Canada Polo Enhancement
Project
Description
AstraZeneca has planned to do an Enhancement in The Promotional Online Ordering -POLO application
which has been used by Business Marketing Executives for Tablet purchases
This is a Mobile Testing Project which involves Testing of POLO Application in IPAD. The Purpose of this
project is to already used application to be implemented in IPAD as Application so the Business users can
easily access the App and Order the Tablets or Promotional Materials
The existingapplication iswritten in Classical ASP,and ASP.NET. Now the business wants to enhance the
existingSystem with latesttechnology as well as some new functionalities needs to be incorporated.The
new system must have all the current functionalities.
With the help of POLO application,themedical representatives placeorders to AstraZeneca. Basically
the representatives help in the promotion of the brochures,drugs or the books that the brands launch.It
distributes the brochures and drugs among the doctors who fall in their territory so that they can apply it
to their patients and check how effective they are so that they can prescribeitin future if found useful.
Doctors with the help of the books provided to them can enhance their knowledge regardingthe new
medicines being launched by different brands.
The medical representatives selects the items, places the orders,request the supervisor for the pre-
approval who in turn requests its supervisor for the final approval.After the request is approved, the
AstraZeneca delivers the items ordered.
The project involves Testingof Application Functionality accordingto the Business Requirements. Testing
of Application involves such that Application works fine in all combinations of Versions of IPAD devices
(Version ios5,io6,io7)Testingof Application is donefor Both Language of Application –English and French
Version
Roles &
Responsibilities
Test scriptpreparation and testartifacts preparation which includes
-Test Approach document, RTM Test scenarios,Testresults,Defect and test logpreparation
Had Involved in Test Design, Test Execution and Defect Management Phases.
Prepared Test Cases documents for English and French versions of POLO application.
Functional Testingis done to ensure that the Application works fineand also the User can able to Plac e
the Order usingthe Application
Performance Testing is done to ensure that the Server connectivity from the Application is atrequired
time response
Project Details
Role Team Lead /Analyst
Team Size 4
Software Platform Windows Vista
Hardware Platform Intel (R)
Devices used APPLE IPAD
Type of testing
• Functional Testing | Performance Testing. | Sanity Testing
7. Kavin Sandron NM
Programmer Analyst (Test Lead & Analyst) –3.2Years-Cognizant Technology Solutions, Chennai.
Graduated from Meenakshi Sundararajan Engg College,Chennai.
kavinsandronnm.msec@gmail.com +91 9677269824
Client : ASTRAZENECA PHARMA LTD . Duration :Oct ’13 to Nov ‘14 (02 Months)
Aspen Sunshine Reporting
Project
Description
Astra Zeneca has planned to Create a Reporting table to Enable its Customers(HCP Professionals and
Medical Representatives) to view the Business reports usingBO Reporting tool. The Main Objective of
this Project is to Test and validatethe Data loaded in Reporting table to ensure that correct data from
Data Mart is loaded in Reporting table.
Testing is carried out for validating the data against the Source Data from Data Mart. Data validation is
carried out to ensure that Logical Transformation is applied according to the Business Requirements
and data is loaded into associated fields of Target table based on Logical transformations.
Roles &
Responsibilities
DW Test scriptpreparation and test artifacts preparation which includes
-Test Approach document, RTM Test scenarios,Test result
Reviewed FollowingDocuments and Ensured that Process adherence is followed throughout the
Project.
-Test Case Documents and Defect and test log Documents.
Worked as Test Lead for the ASPEN Sunshine Project.
Responsiblefor Validation Testing of Sunshine Reports.
Had Prepared Test Strategy and Test Approach document which included Testing scope and entire Test
Plan.
ETL TESTING
ETL testing is done to ensure that the Data load is success from Source to Target database
Validation of Data is done for Data in Target databaseagainstData Mart.
Data validation is performed for Target data to ensure that the Logical Transformation is done as per
Business requirements and Data is populated accordingly fromSource databaseto Target database
Project Details:
Role Test Lead
Team
Size
2
Software Platform Windows Vista
Hardware Platform Intel (R)
Tools SQL DEVELOPER, Informatica,WinSQL
Type of testing
ETL Testing
8. Kavin Sandron NM
Programmer Analyst (Test Lead & Analyst) –3.2Years-Cognizant Technology Solutions, Chennai.
Graduated from Meenakshi Sundararajan Engg College,Chennai.
kavinsandronnm.msec@gmail.com +91 9677269824
Client : ASTRAZENECA PHARMA LTD Duration :May ’13 to Oct ‘13 (06 Months)
AZ AD Symphony DM & BI
Project
Description
Astra Zeneca has planned to Set up a Dashboards to Enableits Customers (HCP Professionalsand
Medical Representatives) to view the Business reports in Apple- I Pad .The Main Objectiveof this Project
is to Test and validatethe Developed dashboard reports to ensure that correct data from Data Mart is
populated in Generated reports .The Report generated can be viewed in I Pads as Dashboards.
Report testing is carried outfor validatingthe report data againstthe Report data from Data Mart. GUI
testing of Dashboards in I Pads is carried outto validatewhether the User is ableto view the Report data
from Reports in Dashboard as per Business Requirements
Roles &
Responsibilities
DW Test scriptpreparation and test artifacts preparation which includes
-RTM Test scenarios,TestDesign,Test results,Defect and test logpreparation.
Status reporting.
Coordination with the Development Team.
Defect Logging and Tracking.
Report testing - Data Validation
Report testing is done to ensure that the correct reports are generated for rightdata, againstgi ven
metrics.
Validation of Data is done for Reports against data from Data Mart
User Interface(UI) Testing
Dashboard testing UI testing is done to ensure that the User is ableto view the Report data from
Dashboard as per Business Requirements
Project Details:
Role Test Engineer/Analyst
Team Size 13
Software Platform Windows Vista
Hardware Platform Intel (R)
Tools SQL DEVELOPER, Informatica,WinSQL, MSTR, SIMON
Devices used APPLE IPAD
Type of testing
Report Testing – Data Validation
Dashboard testing-UI Testing
9. Kavin Sandron NM
Programmer Analyst (Test Lead & Analyst) –3.2Years-Cognizant Technology Solutions, Chennai.
Graduated from Meenakshi Sundararajan Engg College,Chennai.
kavinsandronnm.msec@gmail.com +91 9677269824
Client : ASTRAZENECA PHARMA LTD Duration :Sep ’12 to Mar ‘13 (07 Months)
Emerald Migration Programm e (Middleware Project)
Project
Description
AstraZeneca, following extensive engagement with IBM and a review of the current operating model AZ,
has decided to exit the current IBM relationship as part of a move to New Service Delivery Model
(NSDM). As a result of the AstraZeneca decision to utilize a new provider for infrastructure services
including hosting, applications currently hosted in the IBM managed, World Class Data centers (WDCs)
will be migrated to new Primary Data Centers (PDCs), selected Regional Data Centers (RDCs) and Local
Server Rooms (LSRs), or decommissioned. HCL is the vendor of choice for the migration activities.
AZ Emerald project, a migration based project -The main objective of this project is to Test and Validate
the migration of the Interface connections (an inter-connected architecture between the applications)
from WDC’s to new Primary Data Centers (PDCs) managed by the vendor.
An end to end testing is done to validate the Interfaces connected to the Applications viz. AZIA, Cyclone, BISS,
Active directory and People directory, i.e. Testing the Import and Export of files between the applications,
carried out via the interfaces.
Roles &
Responsibilities
Requirements analysis-Requirement gathering from Support team
Test scriptpreparation and testartifacts preparation which includes RTMTest scenarios,testresults,
defect and test logpreparation.
Involved in test execution (smoke testing and functional testing).
Task allocation,Status reporting, attending defect and status callsand mentoringnew members in the
team.
Followed Life sciences GxP Process for Regulated Applications for which the Middlewarearchitecture
have been migrated
Done Validation Testingfor GxP Regulated and Validated Applications
Migrated nearly 110 applicationsnamely for AZIA (AZ Integrated architecture),BISS, Cycloneserver and
AD(Active Directory)
GDP-Good Documentation Practice->Used LDMS (Light weight Data Management system )Application
for documentation of Test Cases for Regulated Applications
Done Pre and PostMigration Testing for Applications duringMigration fromone infrastructureto
another infrastructure Project Details:
Role Test Engineer/Analyst and Team Lead
Team Size 6
Software Platform Windows Vista
Hardware Middleware –AZIA(AstraZeneca Integrated architecture), Cyclone, BISS server, AD server
Tools SQL DEVELOPER
Devices used -
Type of testing
System testing | End to End Testing | Sanity Testing
10. Kavin Sandron NM
Programmer Analyst (Test Lead & Analyst) –3.2Years-Cognizant Technology Solutions, Chennai.
Graduated from Meenakshi Sundararajan Engg College,Chennai.
kavinsandronnm.msec@gmail.com +91 9677269824
Client : ASTRAZENECA PHARMA LTD Duration :May ’12 to Sep ‘12 (06 Months)
Emerald Migration Programme(US Wave Migration)
Project
Description
AstraZeneca, followingextensive engagement with IBM and a review of the current operatingmodel AZ,
has decided to exit the current IBM relationship as partof a move to New Service Delivery Model
(NSDM). As a resultof the AstraZeneca decision to utilizea new provider for infrastructureservices
includinghosting,applicationscurrently hosted in the IBM managed, World Class Data centres (WDCs)
will bemigrated to new Primary Data Centres (PDCs), selected Regional Data Centres (RDCs) and Local
Server Rooms (LSRs), or decommissioned. HCL is the vendor of choicefor the migration activities.
The scope of this projectis to validatethe functionality of the application after the migration from IBM
to HCL Data Centre. In order to perform this,two rounds of testing is done i.e. Pre Migration and Post
Migration testing. In Pre Migration Testing, a system testing is done to capture the existingfunctionality
that exists in IBM Data Centre. Once the migration is doneto HCL Data Centre, another round of system
testing is done with same sets of test cases and test data, to compare and validatethe Test results in Pre
Migration and PostMigration.Any deviation,whilecomparingis captured as Defect and reported, to
ensure and finalizethe application as a defect free. Many applications arevalidated with these types of
testing and some of them are also automated usingSeleniumTool.
Roles &
Responsibilities
Test script preparation and test artifacts preparation which includes
-RTM Test scenarios , Test results, Defect and test log preparation.
Done Test Execution using Selenium Automation tool and for some Manual test cases
Status reporting, attending defect calls.
Defect Logging and Tracking.
Project Details:
Role Test Engineer/Analyst
Team Size 7
Software
Platform
B.E.(EEE)
Windows Vista
Hardware
Platform
Intel (R)
Tools Selenium
Type of testing
System Testing (Manual and Automation)
11. Kavin Sandron NM
Programmer Analyst (Test Lead & Analyst) –3.2Years-Cognizant Technology Solutions, Chennai.
Graduated from Meenakshi Sundararajan Engg College,Chennai.
kavinsandronnm.msec@gmail.com +91 9677269824
Client : ASTRAZENECA PHARMA LTD Duration :Feb ’12 to May ‘12 (04 Months)
Emerald CLINII (Clinical Information Infrastructure)
Project
Description
CLINII is responsiblefor buildingAstra Zeneca’s Clinical Information infrastructurewhich would serve the
Clinical businesscritical and Futurebusiness needs.The projectfocus towards buildingsolution to the
critical businessneeds.The complete build of the system is for solution buildingand legacy data
migration
The purpose of the CLINII project is to migrate a prioritized set of legacy clinical study data,from their
various currentlocationsto a centralized repository and build a Clinical Data Wa rehouse(CDW). The
process areas areFind Study Information,Co-Locate Study Data & Meta Data,Interpret Medical
Meaning, Load & Transform, Cross Study Analysis,and ManageMedical Meaning. The project involves
four capabilities namely Master Listof Clinical Studies (MLCS), Co-locate,Interpret and Load Where
MLCS (Master Listof Clinical Studies) is a web application built to store and produce a registry of the
majority of clinical studies thatAZ has conducted.
Roles &
Responsibilities
Test script Preparation for the UAT and Functional testing
Test script execution - Dry Run, System Testing, UAT
Defects Management- Defect Logging and Defect Tracker Preparation
Test Log Preparation for the System Testing, UAT
SIR Preparation
Project
DetailsRole Test Engineer/Analyst
Team
Size
6
Software Platform Windows Vista
Hardware Platform Intel (R)
Type of testing
System Testing – Manual