Health IT Summit Beverly Hills 2014 – “A Use Case…Thoughts on How to Leverage your Technology and The Cloud” with Raymond Lowe, Senior Director, Information Technology, Dignity Health
This document provides an agenda and presentation materials for a talk on leveraging cloud technology at Dignity Health. The agenda includes an introduction to Dignity Health, trends in healthcare like telehealth and predictive analytics, Dignity Health's current use of cloud services, steps for migrating to the cloud, and cloud security considerations. Key points discussed are Dignity Health's private health information clouds for applications like EMR systems, using the public cloud for file sharing and collaboration, and the importance of complying with regulations like HIPAA when utilizing cloud services and selecting cloud vendors.
Health IT Summit Beverly Hills 2014 – Case Study “Agile Partnerships to Achieve Common Goals in Lab Information Systems” with Pat Cooke, Chief Information Officer, CellNetrix Pathology and Laboratories
Best Practices for Managing Regulatory Binders ElectronicallyVeeva Systems
- Industry drivers for change and benefits of eRegulatory
- Tips for choosing the right system and evaluating a vendor
- Best practices and mistakes to avoid when going electronic
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
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.
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
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.
Moving to unified PV: Transforming Safety with End-to-end PV SolutionsVeeva Systems
New technologies and approaches to safety and pharmacovigilance are enabling end-to-end processes for greater collaboration and oversight.
During Pharmacovigilance World 2021, Jen Markey, VP Vault Safety Strategy Europe, shared how you can leverage a unified PV solution to improve outsourcing, streamline safety, and make compliance easier.
For more information visit:
www.veeva.com/eu/products/vault-safety
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
Health IT Summit Beverly Hills 2014 – Case Study “Agile Partnerships to Achieve Common Goals in Lab Information Systems” with Pat Cooke, Chief Information Officer, CellNetrix Pathology and Laboratories
Best Practices for Managing Regulatory Binders ElectronicallyVeeva Systems
- Industry drivers for change and benefits of eRegulatory
- Tips for choosing the right system and evaluating a vendor
- Best practices and mistakes to avoid when going electronic
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
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.
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
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.
Moving to unified PV: Transforming Safety with End-to-end PV SolutionsVeeva Systems
New technologies and approaches to safety and pharmacovigilance are enabling end-to-end processes for greater collaboration and oversight.
During Pharmacovigilance World 2021, Jen Markey, VP Vault Safety Strategy Europe, shared how you can leverage a unified PV solution to improve outsourcing, streamline safety, and make compliance easier.
For more information visit:
www.veeva.com/eu/products/vault-safety
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
Cornerstone’s July 29th webinar with Educe Group entitled “Fearing the Cloud: Why the Life Sciences Shouldn’t Fret,” focused on compliance in the cloud in Life Sciences. As with any software utilized within the Biotech and Pharma industry, it is important to understand the overall business intended use and the regulatory and compliance components that drive the overall validation and implementation efforts. This includes a risk-based approach to validation based on the criticality of the business intended use. As with any software, it is very important to understand what the software development process is and how the software is deployed. This is especially true of Cloud-based service models (e.g., IaaS, PaaS, SaaS). This session will focused on the these service models and more importantly considerations for how they should be managed within the Life Sciences industry.
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.
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
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
Designing an EDC System to Work for a CRAVeeva Systems
Watch the video here: https://bit.ly/3h8gHIU
Targeted source data verification (SDV) might be well established, but many clinical teams are still verifying 100% of their data, making monitoring costly and inefficient.
By warching this on demand webinar, you will hear established RBM experts share the measures and metrics that organizations need to realize the true value of targeted SDV. Learn better ways to implement a risk-based strategy for SDV to ensure that CRAs focus on the most important data and how doing so can:
* Improve data quality
* Speed data collection and analysis
* Result in higher confidence and user satisfaction
Learn how Veeva is reinventing EDC to work for a CRA, creating significant speed and quality improvements.
Who Will Benefit:
Senior professionals working with clinical data/clinical documentation, including:
* Clinical Development/ R&D
* Clinical Data Management
* eClinical Operations
* Data Monitoring & Management
* Development Strategic Operations
* Information Strategy & Analytics, Clinical Informatics & Innovation
* Information Technology, R&D IT
* IT R&D Business Partner
Meet Your Presenters:
Drew Garty
Chief Technology Officer, Veeva Vault CDMS, Veeva
Drew Garty’s career in pharmaceutical technology spans over 20 years and includes significant expertise in EDC, clinical site monitoring, platform integrations and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015. Drew joined Veeva in 2016 as Vice President of Product Management, and led the ground-up design of Veeva’s Vault EDC solution. In his current role of Chief Technology Officer at Vault CDMS, Drew shares and collaborates with customers, partners and the industry to set vision and direction of Veeva’s CDMS product.
Dawn Anderson
Managing Director, Life Sciences Strategy and Operations, Deloitte
Dawn has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. Her practice is focused on clinical development and she works with clients to design and deploy global operating strategy, performance improvement and technology implementations across the development of new drugs, biologics and devices. Dawn has spoken frequently about clinical transformation and the future of clinical trials, including topics around adaptive design, protocol complexity, risk assessments and the use of technology including virtual trials, digital, mHealth and the use of clinical analytics platforms and cognitive automation in transforming clinical trial delivery.
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.
Reimagine patient safety 2030 governance through a unified safety platformVeeva Systems
Technology disruptions and healthcare transformation are shifting the roles of QPPV's and senior safety leaders to a more predictive, preventative and participatory safety ecosystem.
During the DIA QPPV Forum, Sharmila Sabaratnam, Senior Director Vault Safety Strategy, shared how you can improve collaboration, benefit-risk data flow and quality and generate insights to maximise patient outcome and minimise avoidable harm through medical governance oversight.
For more information visit:
www.veeva.com/eu/products/vault-safety
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.
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.
To watch the full webinar, register here: https://go.veeva.com/modernquality_webinar2020
Watch this short video to learn more about our upcoming webinar “Modernizing Quality Management”: http://bit.ly/2U8cIAp
Addressing drug shortages and the development of new complex therapies — two top challenges facing manufacturing organizations — require the transformation of quality management using modern systems.
In this webinar, Veeva’s Mike Jovanis, VP of Vault Quality, and Ashley Wentworth, director of quality strategy, will discuss how modern quality systems automate business processes, connect global partners and suppliers, and enable manufacturing agility.
Register for this webinar to learn how:
• Industry trends are driving quality management transformation
• Digitizing manufacturing operations can drive quality improvements
• Companies are benefitting from modern quality systems based on real-world examples
Learning Level:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Who Should Attend:
• Employees of pharma manufacturing, generics, and CMO organizations
• Quality professionals involved with quality systems, quality operations, or GxP Compliance
Speakers:
Michael Jovanis, VP Vault Quality, Veeva Systems
Ashley Wentworth, Director Vault Quality, Veeva Systems
The Industry’s Move Toward Digitally Connected Clinical TrialsVeeva Systems
The rapid adoption of decentralized trials is causing significant challenges – sites are burdened by too many technologies and the use of multiple patient-facing applications adds complexity for patients.
In these slides, we discuss the implications of decentralized trials, share findings from the Veeva Digital Clinical Trials Survey, and explore how clinical leaders are accelerating digital transformation to make studies more site and patient-centric.
Access the Veeva Digital Clinical Trials Survey Report (https://bit.ly/35eAeDn) for additional insights from more than 280 clinical leaders worldwide on the industry’s progress toward digital trial strategies, lessons learned, and what lies ahead.
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.
Building a Business Case for Quality Management TransformationVeeva Systems
Watch the video here: bit.ly/qualitytransformation_ondemand
Transforming quality management to make it easier to comply with regulations and enable faster and more informed decisions is disruptive – impacting people, processes, and systems. With a business case demonstrating anticipated benefits and savings, teams can justify the costs for change, gain stakeholder support, and ensure alignment.
Many organizations have a fragmented system landscape and outdated or manual quality processes. Leading companies are migrating to modern, cloud systems to enable continuous improvement and accelerate transformation initiatives. They are also re-evaluating processes – adopting current best practices and optimizing investments in new technology.
By watching this on demand webinar with quality experts from PriceWaterhouseCoopers (PwC) and Veeva Systems. You will learn how to build a business case to support quality management transformations including:
• Getting a framework for developing business cases
• How to move from a cost to value structure leveraging Quality 4.0
• Recommendations on calculating TCO with key considerations
• Guidance on navigating complex organizations to gain support
Who Will Benefit:
• VP/Director of Quality and Compliance (QA or QC), Quality Systems
• VP/Director of Information Technology, Quality Management Systems, Quality Systems
• VP/Director of Manufacturing Operations/ Quality Operations/ Supply Chain
• Document/Records Managers/ Directors
• Director, Regulatory Operations/ Regulatory Affairs (CMC – Chemistry, Manufacturing, and Control)
• IT System Administrators
• Quality Training Coordinator
Meet Your Presenters:
Jan Paul (JP) Zonnenberg
Partner, Pharmaceutical and Life Sciences Companies, PwC
As a Partner and co-Lead for PwC’s Quality Management Systems Practice, JP’s concentration is in global operations and specifically in quality systems and QMS information technology within the Life Sciences Business Group. With over 28 years’ experience in pharmaceuticals, biotechnology, and medical devices & diagnostics, JP helps leading companies proactively think about developing next generation quality systems to ensure both effective and efficient organizations.
Mike Jovanis
VP Vault Quality, Veeva Systems
As Vice President of the Vault Quality product suite, Mike is responsible for product strategy, customer engagement, and business development. Previously, he served as vice president of product management and strategy for Sparta Systems, where he was instrumental in the company's rapid growth, driving product development, vertical market strategy, and strategic partner alliances. Educated at Rutgers, he holds a bachelor’s degree in marketing and an MBA in strategy and global business.
Integrating efficiency into healthcare - A life cycle approachEstellesc
A facility’s infrastructure is a key component in supporting the mission of the healthcare organization. It is also critical in helping hospitals manage the mounting pressures of reinventing delivery of care, regulatory scrutiny, competition, attracting the best staff, and improving patient outcomes and experience.
There are four primary infrastructures in a hospital: Mechanical, Electrical, Information and Communications Technology and Security. Each division of infrastructure functions to bind the physical environment to clinical outcomes; to provide safe, comfortable and reliable environments for quality patient care; and to ensure the financial viability of the organization.
This webcast examines how properly designed and executed, the Integrated Healthcare Facilities Infrastructure will improve financial performance, improve patient and staff safety, simplify regulatory practices, and increase patient satisfaction, staff productivity and retention. The Integrated Healthcare Facilities Infrastructure approach is designed to utilize the intelligence inherent to facility infrastructure technologies, and implement them in a manner to make it simple for operators to realize optimal efficiencies from facilities now, and in the future.
The Benefits of a Seamless IRT and EDC Integration in Clinical Trial ExecutionVeeva Systems
Watch the video here: https://bit.ly/3upehbN
Veeva and Suvoda have combined their offerings into a powerful streamlined integration, which accommodates advanced study designs while driving down build and casebook complexity.
Hear Catherine Munera, head of biometrics at Cara Therapeutics, share the benefits of moving from a single provider to taking a harmonized, best-of-breed approach with IRT and EDC.
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
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.
Cornerstone’s July 29th webinar with Educe Group entitled “Fearing the Cloud: Why the Life Sciences Shouldn’t Fret,” focused on compliance in the cloud in Life Sciences. As with any software utilized within the Biotech and Pharma industry, it is important to understand the overall business intended use and the regulatory and compliance components that drive the overall validation and implementation efforts. This includes a risk-based approach to validation based on the criticality of the business intended use. As with any software, it is very important to understand what the software development process is and how the software is deployed. This is especially true of Cloud-based service models (e.g., IaaS, PaaS, SaaS). This session will focused on the these service models and more importantly considerations for how they should be managed within the Life Sciences industry.
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.
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
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
Designing an EDC System to Work for a CRAVeeva Systems
Watch the video here: https://bit.ly/3h8gHIU
Targeted source data verification (SDV) might be well established, but many clinical teams are still verifying 100% of their data, making monitoring costly and inefficient.
By warching this on demand webinar, you will hear established RBM experts share the measures and metrics that organizations need to realize the true value of targeted SDV. Learn better ways to implement a risk-based strategy for SDV to ensure that CRAs focus on the most important data and how doing so can:
* Improve data quality
* Speed data collection and analysis
* Result in higher confidence and user satisfaction
Learn how Veeva is reinventing EDC to work for a CRA, creating significant speed and quality improvements.
Who Will Benefit:
Senior professionals working with clinical data/clinical documentation, including:
* Clinical Development/ R&D
* Clinical Data Management
* eClinical Operations
* Data Monitoring & Management
* Development Strategic Operations
* Information Strategy & Analytics, Clinical Informatics & Innovation
* Information Technology, R&D IT
* IT R&D Business Partner
Meet Your Presenters:
Drew Garty
Chief Technology Officer, Veeva Vault CDMS, Veeva
Drew Garty’s career in pharmaceutical technology spans over 20 years and includes significant expertise in EDC, clinical site monitoring, platform integrations and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015. Drew joined Veeva in 2016 as Vice President of Product Management, and led the ground-up design of Veeva’s Vault EDC solution. In his current role of Chief Technology Officer at Vault CDMS, Drew shares and collaborates with customers, partners and the industry to set vision and direction of Veeva’s CDMS product.
Dawn Anderson
Managing Director, Life Sciences Strategy and Operations, Deloitte
Dawn has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. Her practice is focused on clinical development and she works with clients to design and deploy global operating strategy, performance improvement and technology implementations across the development of new drugs, biologics and devices. Dawn has spoken frequently about clinical transformation and the future of clinical trials, including topics around adaptive design, protocol complexity, risk assessments and the use of technology including virtual trials, digital, mHealth and the use of clinical analytics platforms and cognitive automation in transforming clinical trial delivery.
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.
Reimagine patient safety 2030 governance through a unified safety platformVeeva Systems
Technology disruptions and healthcare transformation are shifting the roles of QPPV's and senior safety leaders to a more predictive, preventative and participatory safety ecosystem.
During the DIA QPPV Forum, Sharmila Sabaratnam, Senior Director Vault Safety Strategy, shared how you can improve collaboration, benefit-risk data flow and quality and generate insights to maximise patient outcome and minimise avoidable harm through medical governance oversight.
For more information visit:
www.veeva.com/eu/products/vault-safety
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.
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.
To watch the full webinar, register here: https://go.veeva.com/modernquality_webinar2020
Watch this short video to learn more about our upcoming webinar “Modernizing Quality Management”: http://bit.ly/2U8cIAp
Addressing drug shortages and the development of new complex therapies — two top challenges facing manufacturing organizations — require the transformation of quality management using modern systems.
In this webinar, Veeva’s Mike Jovanis, VP of Vault Quality, and Ashley Wentworth, director of quality strategy, will discuss how modern quality systems automate business processes, connect global partners and suppliers, and enable manufacturing agility.
Register for this webinar to learn how:
• Industry trends are driving quality management transformation
• Digitizing manufacturing operations can drive quality improvements
• Companies are benefitting from modern quality systems based on real-world examples
Learning Level:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Who Should Attend:
• Employees of pharma manufacturing, generics, and CMO organizations
• Quality professionals involved with quality systems, quality operations, or GxP Compliance
Speakers:
Michael Jovanis, VP Vault Quality, Veeva Systems
Ashley Wentworth, Director Vault Quality, Veeva Systems
The Industry’s Move Toward Digitally Connected Clinical TrialsVeeva Systems
The rapid adoption of decentralized trials is causing significant challenges – sites are burdened by too many technologies and the use of multiple patient-facing applications adds complexity for patients.
In these slides, we discuss the implications of decentralized trials, share findings from the Veeva Digital Clinical Trials Survey, and explore how clinical leaders are accelerating digital transformation to make studies more site and patient-centric.
Access the Veeva Digital Clinical Trials Survey Report (https://bit.ly/35eAeDn) for additional insights from more than 280 clinical leaders worldwide on the industry’s progress toward digital trial strategies, lessons learned, and what lies ahead.
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.
Building a Business Case for Quality Management TransformationVeeva Systems
Watch the video here: bit.ly/qualitytransformation_ondemand
Transforming quality management to make it easier to comply with regulations and enable faster and more informed decisions is disruptive – impacting people, processes, and systems. With a business case demonstrating anticipated benefits and savings, teams can justify the costs for change, gain stakeholder support, and ensure alignment.
Many organizations have a fragmented system landscape and outdated or manual quality processes. Leading companies are migrating to modern, cloud systems to enable continuous improvement and accelerate transformation initiatives. They are also re-evaluating processes – adopting current best practices and optimizing investments in new technology.
By watching this on demand webinar with quality experts from PriceWaterhouseCoopers (PwC) and Veeva Systems. You will learn how to build a business case to support quality management transformations including:
• Getting a framework for developing business cases
• How to move from a cost to value structure leveraging Quality 4.0
• Recommendations on calculating TCO with key considerations
• Guidance on navigating complex organizations to gain support
Who Will Benefit:
• VP/Director of Quality and Compliance (QA or QC), Quality Systems
• VP/Director of Information Technology, Quality Management Systems, Quality Systems
• VP/Director of Manufacturing Operations/ Quality Operations/ Supply Chain
• Document/Records Managers/ Directors
• Director, Regulatory Operations/ Regulatory Affairs (CMC – Chemistry, Manufacturing, and Control)
• IT System Administrators
• Quality Training Coordinator
Meet Your Presenters:
Jan Paul (JP) Zonnenberg
Partner, Pharmaceutical and Life Sciences Companies, PwC
As a Partner and co-Lead for PwC’s Quality Management Systems Practice, JP’s concentration is in global operations and specifically in quality systems and QMS information technology within the Life Sciences Business Group. With over 28 years’ experience in pharmaceuticals, biotechnology, and medical devices & diagnostics, JP helps leading companies proactively think about developing next generation quality systems to ensure both effective and efficient organizations.
Mike Jovanis
VP Vault Quality, Veeva Systems
As Vice President of the Vault Quality product suite, Mike is responsible for product strategy, customer engagement, and business development. Previously, he served as vice president of product management and strategy for Sparta Systems, where he was instrumental in the company's rapid growth, driving product development, vertical market strategy, and strategic partner alliances. Educated at Rutgers, he holds a bachelor’s degree in marketing and an MBA in strategy and global business.
Integrating efficiency into healthcare - A life cycle approachEstellesc
A facility’s infrastructure is a key component in supporting the mission of the healthcare organization. It is also critical in helping hospitals manage the mounting pressures of reinventing delivery of care, regulatory scrutiny, competition, attracting the best staff, and improving patient outcomes and experience.
There are four primary infrastructures in a hospital: Mechanical, Electrical, Information and Communications Technology and Security. Each division of infrastructure functions to bind the physical environment to clinical outcomes; to provide safe, comfortable and reliable environments for quality patient care; and to ensure the financial viability of the organization.
This webcast examines how properly designed and executed, the Integrated Healthcare Facilities Infrastructure will improve financial performance, improve patient and staff safety, simplify regulatory practices, and increase patient satisfaction, staff productivity and retention. The Integrated Healthcare Facilities Infrastructure approach is designed to utilize the intelligence inherent to facility infrastructure technologies, and implement them in a manner to make it simple for operators to realize optimal efficiencies from facilities now, and in the future.
The Benefits of a Seamless IRT and EDC Integration in Clinical Trial ExecutionVeeva Systems
Watch the video here: https://bit.ly/3upehbN
Veeva and Suvoda have combined their offerings into a powerful streamlined integration, which accommodates advanced study designs while driving down build and casebook complexity.
Hear Catherine Munera, head of biometrics at Cara Therapeutics, share the benefits of moving from a single provider to taking a harmonized, best-of-breed approach with IRT and EDC.
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
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.
Similar to Health IT Summit Beverly Hills 2014 – “A Use Case…Thoughts on How to Leverage your Technology and The Cloud” with Raymond Lowe, Senior Director, Information Technology, Dignity Health
Webinar presented live on April 11, 2017.
The Cloud Standards Customer Council has published version 2.0 of the Impact of Cloud Computing on Healthcare whitepaper.
Over the past several years, the market dynamics of the healthcare industry have changed significantly with the growing impact of consumerism, digitalization, preventative healthcare and regulations. Attend this webinar to gain a fresh perspective on the current market dynamics, challenges and benefits of cloud computing on healthcare IT.
The webinar presentation will cover:
- Benefits and key considerations of leveraging cloud computing for healthcare IT
- Specific IT trends in the healthcare industry that are addressed most effectively, both technically and economically, by cloud computing
- Guidance on how best to achieve the benefits of cloud computing
Read the whitepaper: http://www.cloud-council.org/deliverables/impact-of-cloud-computing-on-healthcare.htm
It is now more important than ever to ensure your breach security is on par or better than the rest of the industry. Review these slides to ensure you understand the regulations surrounding patient privacy and how to prevent future breaches.
Moving to the Cloud: Modernizing Data Architecture in HealthcarePerficient, Inc.
Constant changes in the healthcare industry continue to drive innovation in technology and serve as a catalyst for cloud adoption. This trend will continue to evolve and accelerate in the coming years with the increasing need to store and analyze vast amounts of information for personal and population health initiatives.
We joined guest speaker from HIMSS Analytics, James Gaston, to discuss the impact of the cloud on data architecture in healthcare. Topics included:
-The benefits and risks of moving data and analytics environments to the cloud
-Main healthcare use cases for cloud migration
-Deep dive into two leading healthcare organizations’ cloud journeys including drivers, challenges, benefits, and lessons learned
How can healthcare organizations effectively use and manage services and the cloud? This presentation outlines:
- Benefits you should expect;
- Risks to manage;
- Evaluating which managed services model fits best;
- Common factors that lead to successful achievement of goals.
Importance of Healthcare Compliance SolutionsAegify Inc.
Today, with the plethora of regulations enacted by numerous governing bodies, people can question about the requirement for yet another regulation relating to health care compliance. There are cases, when while assuring that that your healthcare facilities are Medicare compliant, there can be certain complications in the process itself.
Data Breaches and Security: Ditching Data Disasters-Michael McNeil, Philips H...IT Network marcus evans
Michael McNeil, Global Product Security & Services Officer, Philips Healthcare delivered his presentation entitled Data Breaches and Security: Ditching Data Disasters at the marcus evans CIO Summit 2016 in Los Angeles, CA
Use of the COBIT Security Baseline as a framework for an information
security program at a large state agency. Presented at the 2005 MN Govt IT
Symposium.
CTO Perspectives: What's Next for Data Management and Healthcare?Health Catalyst
Health Catalyst's Chief Technology Officer, Bryan Hinton, shares his perspective, thoughts, and insights on new and emerging trends for data management in healthcare. Bryan offers a brief presentation on what hospitals and healthcare systems can expect, followed by an extended Q&A.
Diaspark healthcare offers software product development, compliance implementation and mobility services to healthcare software vendors (EMR/EHR/HIE/HIS/ Home Healthcare), life science companies and non-profits. Right from developing key EHR software modules spanning CPOE, Patient Portals, eRX(ePrescription), eMAR, Clinical DSS, labs to building healthcare mobile apps over iOS, Android, Blackberry that even interact with health devices, we work as an extended enterprise to software product vendors and life science companies.
Cloud Cybersecurity: Strategies for Managing Vendor RiskHealth Catalyst
As more organizations shift away from on-premise architectures toward the cloud or hybrid hosting models, critical cybersecurity concerns emerge. Organizations, especially health systems, should carefully examine the shared responsibility model in partnership with their cloud vendor.
Kevin Scharnhorst, Health Catalyst Chief Information Security Officer, shares perspectives on how your organization’s security program, through adherence to standards-based policy and procedures, can align with your cloud vendor on reduced organizational risk.
Similar to Health IT Summit Beverly Hills 2014 – “A Use Case…Thoughts on How to Leverage your Technology and The Cloud” with Raymond Lowe, Senior Director, Information Technology, Dignity Health (20)
Development and implementation of a system to support prediction of suicide risk in the Department of Veterans Affairs - DR. Robert Bossarte and Paul Bradley
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Health IT Summit Beverly Hills 2014 – “A Use Case…Thoughts on How to Leverage your Technology and The Cloud” with Raymond Lowe, Senior Director, Information Technology, Dignity Health
1. Draft – For Discussion Purposes
A use case… thoughts on how to leverage your technology and the cloud
Iht2 Conference – Beverly Hills
November 4, 2014
Raymond Lowe
Senior Director Enterprise IT Infrastructure and Technology’
2. Draft – For Discussion Purposes
2
•Dignity Health – Hello Humankindness
•Data Centers and Cloud
–Where are you in the cloud?
•Dignity Health and the cloud
–Big 7 trends in Healthcare
•Steps to the Cloud
•Cloud Security
•Questions and Answers
Agenda
3. Draft – For Discussion Purposes
Dignity Health
3
4. Draft – For Discussion Purposes
Who is Dignity Health
•Assets: $13.1 billion
•Net Operating Revenue: $10.6 billion
•General Acute Patient Care Days: 1.8 million
•Community Benefits and Care of the Poor: $1.4 billion
•Acute Care Beds: 8,800
•Skilled Nursing Beds: 800
•Acute Care Hospitals: 40
•Clinics/Ancillary Care Centers: 150
•Medical Foundations: 11
•Active Physicians: 10,000
•Total Employees: 55,000
4
5. Draft – For Discussion Purposes
Aligning Dignity Health for Future Success
5
Operating company with strong local leadership
Focus on markets, not hospitals
Aligns system and market leaders
Fosters clinical enterprise focus
Enables streamlined decision making
Creates greater accountability for outcomes
Responsive to community needs
10. Draft – For Discussion Purposes
1.Do you have any ASP hosted applications?
2.Do you use Box, Dropbox, MS OneDrive?
3.Are your backup being electronically stored outside of the walls of your facility?
4.Does your Disaster Recovery and business continuity storage leave your facilities?
Poll the Audience
11. Draft – For Discussion Purposes
Dignity Health – Cloud
12. Draft – For Discussion Purposes
Big 7 Trends in Health Care
1.Personalized Health Services
•Transition from not-for-profit, one-time acute episodes to for-profit, recurring wellness services
2.Consumerism
•Embrace that health care is consumer-driven with many choices of retail experiences
3.Employer Direct
•Market a comprehensive, service-based network direct to employers with a focus on the self-funded employers - instead of relying on insurers and payers
4.Telehealth
•Expand core PCP and specialist services across the continuum of care with global reach and local partnerships for best-in-class hybrid delivery model
5.Cloud
•Provide interoperability with a consumer-focused “outside-in” perspective – integrating across many SaaS/IaaS/PaaS partners for speed-to-market
6.IP-Enabled Medical Devices
•Integrate wearables, implantibles for real-time monitoring, alerting, diagnosing, and prescribing that connect to the Internet of Medical Things
7.Predictive Analytics
•Drive care quality and cost efficiencies with analytics that forge new pathways from chronic to preventative to wellness
13. Draft – For Discussion Purposes
Big Trend #5: The Cloud Is Already Here at Dignity Health
Private PHI Cloud:
Enterprise Data
Warehouse (SAS)
Private PHI Cloud:
EMR (Cerner)
Proprietary DC’s:
- Patient Revenue
Cycle (Lawson)
- Ambulatory EMR
(Allscripts)
- MS Exchange,
Sharepoint
PHI Co-Lo: Disaster Recovery (Switch)
Public Cloud:
Social Collaboration
(Yammer @Microsoft Azure)
Private PHI Cloud:
Patient Portal (MedSeek)
Private PHI Cloud: HIE (MobileMD)
Private PHI Cloud:
Pathology Reporting
(Olympus EndoWorks)
Dignity Health PHI: Clinical Applications in the Cloud
Public Cloud:
File Sharing (Box)
14. Draft – For Discussion Purposes
Steps to the Cloud
15. Draft – For Discussion Purposes
15
1.Define Cloud Security Governance and Policies
2.Define approach to standardize the current architecture
3.Develop and use a target state architecture to define standards
4.Buy commoditized cloud services and capabilities whenever possible without exposing PHI.
5.Migrate existing applications and systems into private/hybrid cloud using phased approach
6.Decommission existing legacy systems as new capabilities come online within your target state environment
Steps to Cloud Computing
16. Draft – For Discussion Purposes
16
Rationalizing, standardizing and consolidation of applications and infrastructure.
Application Migration Strategy
17. Draft – For Discussion Purposes
Cloud Security
18. Draft – For Discussion Purposes
18
Threats, Vulnerabilities, and Exposures are Increasing
April, 2014
4,500,000 individuals
February, 2014
405,000 individuals
Healthcare Industry
HIPAA Breaches and Fines
33,800,000 individuals
September, 2010
6,800 individuals
$4.5M fine May, 2014
Consumer and Business Breaches
July, 2013 4,000,000 individuals
July, 2011
4,900,000 individuals
2011
20,000 individuals
$4M settlement March, 2014
December, 2009
1,200,000 individuals
$3M settlement March, 2014
19. Draft – For Discussion Purposes
19
Situational Analysis:
–Cloud computing has many facets to address for public, private or hybrid cloud solution deployment – including cost, infrastructure, software, platforms, contractual, management oversight, audit and security.
–Important aspects for security in a virtualized environment and security defenses include confidentiality, integrity and availability. Further security analysis includes governance, risk management and compliance; including implementation visibility and auditing rights of security controls.
–However, the most critical business decision point for leadership, assuming appropriate security, legal and audit controls are in place – is the decision point to include HIPAA regulatory requirements and accompanying Business Associate agreements in the cloud decision – as these compliance measures are at the most fundamental core on how Dignity Health protects PHI/ePHI-based business applications.
Business Decision Point for Cloud Computing
Undeniably, Cloud Computing is present at Dignity Health in various forms. However, as additional deployment options are developed driven by strategic business reasons, leadership must address a critical decision point in the deployment of cloud-based solutions at Dignity Health.
20. Draft – For Discussion Purposes
20
Development of a Cloud Security Plan
1. Specific Business Goals
•Regulatory Compliance
•Organization Objectives & Capabilities Risk
•Enable Technologies, Processes and People
•Provide an aggregated view of the risk profile the company accept
•ITILv3, ISO 2700X and NIST
•3rd Party Relationships & Business Associates (HIPAA)
2. Risk Management Program
3. Develop a Security Plan to Support Business Goals
4. Audit, Review and Continuously Improve
•Compliance program, technologies, and processes with very specific results
•HIPAA, HITECH, SSAE 16
•Monitor changing Government & Regulatory Landscape (Omnibus)
•Continue to expand HIPAA Compliance, PCI, Meaningful Use for all Stages
•Risk Assessment as a Continuous Process and ‘Way of Thinking’
Key Considerations
•Security of Enterprise Applications & PHI
•Compliant Managed Cloud Service Provider
•Take an active role in Security & Risk management
4
3
2
1
Enterprise Cloud Security Plan
21. Draft – For Discussion Purposes
21
Regulatory, Compliance & Control Objectives Overview
•The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) drives important protections, that require an entity providing a service to a provider, to control Protected Health Information (“PHI”)
•A Business Associate Agreement (“BAA”) has significant contractual obligations by the service provider for covered entities, such as Dignity Health. A BAA shall have the meaning ascribed to them in HIPAA as contained in 45 CFR parts 160, 162 and 164, and of the American Recovery Act of 2009 (the “HITECH Act”)
•HIPAA regulations include “HIPAA Privacy Regulations” (CFR Parts 160 & 164), “HIPAA Security Regulations” (CFR parts 160 & 164) , “HIPAA Transaction Regulations” ( CFR Parts 160 & 162), and “HIPAA Breach Notification” (CFR Part 164 Subpart D, and the HITECT Act)
Healthcare Regulatory Drivers
•An important security framework which provides a structured methodology for analysis is ISO27001
•Payment Card Industry (“PCI”) has important considerations for cloud provider selection
Security Frameworks and Control Objectives
Drivers and Controls
22. Draft – For Discussion Purposes
22
Business Associate Agreement Responsibilities
BAA Service Objectives
A BAA Upon Commencement of Service Shall Agree to the Following Terms
Security Incidents and Breach of Unsecured PHI
Compliance Audits
Information Safeguards, Mitigation
Subcontractor and Agents
Changing Regulatory and Compliance requirements
Permitted Uses and Disclosures
Accounting Disclosures
Consent, Authorization, and Permission
Designated Record Sets
Minimum Necessary and Limited Data Sets
Right to Terminate for Breach, Effects of Termination, Amendments, and Conflicts
Marketing Use of PHI, Non-Permitted Use, and Uses or Disclosure Restrictions
A BAA has significant contractual obligations, driven by
Federal Regulations - continued oversight is essential.
23. Draft – For Discussion Purposes
23
ISO 27001:2005 Security Domains
Security Objectives
Regardless of Health Care Regulations, Cloud Providers Must Address the Following Security Controls
Human Resources Security
Security Policy
Asset Management
Communications and Operations Management
Environmental and Physical Security
Information Security Governance
Business Continuity Management
Encryption
Information Systems Acquisition
Information Security Incident Management
Compliance
Access Control
Security practitioners for Cloud Providers will baseline control
objectives against these well understood security domains.
24. Draft – For Discussion Purposes
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Cloud Security Defense Best Practices
Cloud Governance
Align with recognized industry standards, including internal security policies, standards and processes to both internal audits and external certifications.
Security Governance, Risk Management and Compliance
Robust security compliance program. Including physical access, logical access with internal and external auditing.
Problem and Information Security Incident Management
Documented policies and procedures for management and monitoring of security events, including escalation and resolution.
Identity and Access Management
Ensure access is tightly controlled. Privileged user monitoring to ensure enforcement and compliance to customer data protections.
Categorize and Protect Data and Information Assets
Encryption in-flight, @Rest and backups. Key Management if necessary. Protection of portable media and storage device disposal controls.
System Acquisition, Development and Maintenance
Security applied throughout lifecycle, Hypervisors Common Criteria certified and hardened servers
Secure Infrastructure Against Threats and Vulnerabilities
Defense in depth, underpinned with people and technology, IDPS @ boundary, vulnerability scanning, configuration mngt & security zones
Physical and Personnel Security
Strong physical controls, including CCTV, biometric authentication, resiliency tools and door alarms. Employee training of customer data handling and protections.
Secure by Design
25. Draft – For Discussion Purposes
Questions & Answers
25