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Many organizations have a fragmented system landscape and outdated or manual quality processes.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.
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
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
Cloud Adoption Framework Phase one-moving to the cloudAnthony Clendenen
This is the first phase in the cloud adoption framework. It includes getting started and a cloud readiness section to determine the overall readiness for cloud adoption.
Establishing a Business Process Management Center of Excellence - Impact 2012Prolifics
Speakers: Benny Higdon, Prolifics; Howard Webb, Prolifics
Description: Introducing a new technology in to an enterprise may be fraught with problems. The same is true for Business Process Management (BPM), which are both a technology and a methodology. Establishing a properly staffed and empowered Center of Excellence (CoE) can improve your chances of success. Learn the considerations for setting up a BPM CoE in your organization.
A Starter Guide to IT Managed ServicesDavid Castro
Making the switch to MSP is worth the time and effort because MSPs are approximately 200-400% more profitable than non-MSPs. And MSPs are 3x to 10x more valuable than traditional VARs. This 21-page guide will help you: --Develop and execute on a solid business strategy for running a managed services company --Choose the right IT systems management solution to help enable your vision --Price your managed services fairly, competitively, and profitably --Understand MSP pricing and profit scenarios including cost, profit, and MRR/project/breakfix calculations and analysis --Avoid some common pitfalls --Understand the benefits that come with implementing managed services correctly --Understand how an IT service provider successfully rolled out managed services for its customers and transformed into one of the largest MSPs in the country. December 2012.
Reengineering The IT Operating Model to Embrace The Power Of The Cloudaccenture
Cloud winners and losers: Massively scalable and resource-elastic businesses are clobbering incumbents. Why?
Because many traditional businesses have failed to realize the full power of the cloud. They have simply taken the new technology and deployed it using their existing IT operating model.
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
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
Cloud Adoption Framework Phase one-moving to the cloudAnthony Clendenen
This is the first phase in the cloud adoption framework. It includes getting started and a cloud readiness section to determine the overall readiness for cloud adoption.
Establishing a Business Process Management Center of Excellence - Impact 2012Prolifics
Speakers: Benny Higdon, Prolifics; Howard Webb, Prolifics
Description: Introducing a new technology in to an enterprise may be fraught with problems. The same is true for Business Process Management (BPM), which are both a technology and a methodology. Establishing a properly staffed and empowered Center of Excellence (CoE) can improve your chances of success. Learn the considerations for setting up a BPM CoE in your organization.
A Starter Guide to IT Managed ServicesDavid Castro
Making the switch to MSP is worth the time and effort because MSPs are approximately 200-400% more profitable than non-MSPs. And MSPs are 3x to 10x more valuable than traditional VARs. This 21-page guide will help you: --Develop and execute on a solid business strategy for running a managed services company --Choose the right IT systems management solution to help enable your vision --Price your managed services fairly, competitively, and profitably --Understand MSP pricing and profit scenarios including cost, profit, and MRR/project/breakfix calculations and analysis --Avoid some common pitfalls --Understand the benefits that come with implementing managed services correctly --Understand how an IT service provider successfully rolled out managed services for its customers and transformed into one of the largest MSPs in the country. December 2012.
Reengineering The IT Operating Model to Embrace The Power Of The Cloudaccenture
Cloud winners and losers: Massively scalable and resource-elastic businesses are clobbering incumbents. Why?
Because many traditional businesses have failed to realize the full power of the cloud. They have simply taken the new technology and deployed it using their existing IT operating model.
Although the Cloud is now mainstream for many large Enterprises, organisations who truly aim to maximise the value of their cloud platform also focus on refactoring the model by which they operate their IT. In this session you will learn about the latest developments in operations within the cloud, including operational processes, architecture, governance, organisation structure, and monitoring tools to maximise agility. This session will highlight the features of a Cloud-enabled IT operating model and how AWS customers benefit from delivering a new approach to IT.
Speaker: Andrew Mitchell, Solutions Architect, Amazon Web Services
Featured Customer - NAB
Digital Transformation And Solution ArchitectureAlan McSweeney
Digital strategy is a statement about the organisation’s digital positioning, competitors and customer and collaborator needs and behaviour to achieve a direction for innovation, communication, transaction and promotion. Digital strategy needs to be defined in the same framework structure as the proposed digital architecture platform.
Achieving the target digital organisation means deploying solutions that enable the digital architecture. Solution architecture needs to design solutions that fit into the target digital architecture framework. This requires:
• Solution architecture team operating in an integrated manner designing solutions to a set of common standards and that run on the platform
• Solution architecture team leadership ensuring solutions conform to the common standards
• Solution architecture technical leadership to develop and maintain common solution design standards
• Solution architecture updates the digital reference architecture based on solution design experience
Digital solution design requires greater discipline to create an integrated set solutions that operate within the rigour of the digital architecture framework. The solution architecture function must interact with other IT architecture disciplines to ensure the set of solutions that implement the digital framework operate together. This requires greater solution architecture team leadership. This needs to be supplemented and supported by a well-defined set of digital solution design standards.
This follows-on from the previous presentation: Digital Transformation And Enterprise Architecture
https://www.slideshare.net/alanmcsweeney/digital-transformation-and-enterprise-architecture.
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.
Business Process Management Training | By ex-Deloitte & McKinsey ConsultantsAurelien Domont, MBA
Business Process Management Training in 100 re-usable Powerpoint slides | By ex-Deloitte & McKinsey Consultants | Downloadable at www.slidebooks.com | Includes Tools, Templates, Frameworks, Principles
Presentation given at the BPM Executive Day, Bogota, Colombia, December 4, 2012. The presentation outlines the different dimensions of BPM activities an organization should consider when organizing their BPM efforts.
Solution Architecture and Solution AcquisitionAlan McSweeney
This describes a systematised and structured approach to solution acquisition or procurement that involves solution architecture from the start. This allows the true scope of both the required and subsequently acquired solution are therefore fully understood. By using such an approach, poor solution acquisition outcomes are avoided.
Solution architecture provides the structured approach to capturing all the cost contributors and knowing the true solution scope.
There is more packaged/product/service-based solution acquisition activity. There is an increasing trend of solutions hosted outside the organisation. Meanwhile solution acquisition outcomes are poor and getting worse.
Poor solution acquisition has long-term consequences and costs.
The to-be-acquired solution needs to operate in and co-exist with an existing solution topography and the solution acquisition process needs to be aware of and take account of this wider solution topography. Cloud-based or externally hosted and provided solutions do not eliminate the need for the solution to exist within the organisation solution topography.
Strategic misrepresentation in solution acquisition is the deliberate distortion or falsification of information relating to solution acquisition costs, complexity, required functionality, solution availability, resource availability, time to implement in order to get solution acquisition approval. Strategic misrepresentation is very real and its consequences can be very damaging.
Solution architecture has the skills and experience to define the real scope of the solution being acquired. An effective structured solution acquisition process, well-implemented and consistently applied, means dependable and repeatable solution acquisition and successful outcomes.
Unlock the Value of ITIL 4 with 5 Key Takeaways that can be Used Today!Axios Systems
As ITIL continues to evolve and expand to provide a holistic and integrated view of IT Service Management it is easy to lose sight of the fundamental practices that make day-to-day IT management life sustainable. In this practical webinar, Troy DuMoulin and Ed Perez will look at 5 Key Takeaways any organization can use from ITIL 4 best practices that enable improved service delivery without complex requirements and high levels of process maturity.
Gartner: Seven Building Blocks of Master Data ManagementGartner
Gartner will further examine key trends shaping the future MDM market during the Gartner MDM Summit 2011, 2-3 February in London. More information at www.europe.gartner.com/mdm.
Cloud Migration, Application Modernization and Security for PartnersAmazon Web Services
As AWS continues to expand, enterprise customers are increasingly looking to our partner ecosystem to assist in migrating their workloads to the cloud. This session describes the challenges, lessons learned, and best practices for large-scale application migrations. We will use real examples from our consulting partners and AWS Professional Services to illustrate how to move workloads to the cloud while modernizing the associated applications to take advantage of the unique benefits of AWS. We will also dive into how to use an array of AWS services and features to improve customers' security posture as they migrate and once they are up and running in the cloud.
"You can download this product from SlideTeam.net"
Achieve operational excellence with our creatively designed Continuous Improvement PowerPoint Presentation Slides. This business operational excellence framework presentation deck includes a set of professionally designed PowerPoint templates such as company history of operational excellence capabilities, evaluate the existing operational gaps, design an evaluation process, ensure continuous improvement, implementing regional operations, analytics of achieving operational excellence, monitor performance, etc. Not only this, to cover all the important concepts our designers have included additional templates e.g. our target, mission and vision, timeline, target, thank you, financial charts, etc. Outline the factors that make continuous improvement successful. The process improvement methodology PPT slideshow have all visually appealing graphics with in-depth researched content. Furthermore, with the support of our evaluation process presentation design, you can portray various concepts like strategy deployment, performance management, continuous improvement, organizational excellence, process excellence, leading people and culture, etc. Download the business improvement process presentation deck for evaluation and improving business processes. Increase the inflow with our Continuous Improvement Powerpoint Presentation Slides. Ensure good ideas continue to be generated. https://bit.ly/3BCixJz
Core Banking Transformation: Solutions to Standardize Processes and Cut CostsIBM Banking
IBM Banking Industry Framework for Core Banking Transformation (CBTF) has many assets, tools, methods and accelerators to help banks standardize and link core processes seamlessly and reduce point-to-point interfaces to cut cost and complexity.
Managed IT Services Pricing Models And Strategies Powerpoint Presentation SlidesSlideTeam
"You can download this product from SlideTeam.net"
Presenting Managed IT Services Pricing Models And Strategies PowerPoint Presentation Slides. This complete PPT deck is made up of 40 professional slides. You can convert and save this PowerPoint slideshow in formats like PDF, PNG, and JPG. All the templates are fully customizable. You can edit text, fonts, patterns, colors, and background within seconds. Also, this PPT template deck is compatible with Google Slides. You can view this presentation on standard and widescreen formats. https://bit.ly/36YwIxW
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
Although the Cloud is now mainstream for many large Enterprises, organisations who truly aim to maximise the value of their cloud platform also focus on refactoring the model by which they operate their IT. In this session you will learn about the latest developments in operations within the cloud, including operational processes, architecture, governance, organisation structure, and monitoring tools to maximise agility. This session will highlight the features of a Cloud-enabled IT operating model and how AWS customers benefit from delivering a new approach to IT.
Speaker: Andrew Mitchell, Solutions Architect, Amazon Web Services
Featured Customer - NAB
Digital Transformation And Solution ArchitectureAlan McSweeney
Digital strategy is a statement about the organisation’s digital positioning, competitors and customer and collaborator needs and behaviour to achieve a direction for innovation, communication, transaction and promotion. Digital strategy needs to be defined in the same framework structure as the proposed digital architecture platform.
Achieving the target digital organisation means deploying solutions that enable the digital architecture. Solution architecture needs to design solutions that fit into the target digital architecture framework. This requires:
• Solution architecture team operating in an integrated manner designing solutions to a set of common standards and that run on the platform
• Solution architecture team leadership ensuring solutions conform to the common standards
• Solution architecture technical leadership to develop and maintain common solution design standards
• Solution architecture updates the digital reference architecture based on solution design experience
Digital solution design requires greater discipline to create an integrated set solutions that operate within the rigour of the digital architecture framework. The solution architecture function must interact with other IT architecture disciplines to ensure the set of solutions that implement the digital framework operate together. This requires greater solution architecture team leadership. This needs to be supplemented and supported by a well-defined set of digital solution design standards.
This follows-on from the previous presentation: Digital Transformation And Enterprise Architecture
https://www.slideshare.net/alanmcsweeney/digital-transformation-and-enterprise-architecture.
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.
Business Process Management Training | By ex-Deloitte & McKinsey ConsultantsAurelien Domont, MBA
Business Process Management Training in 100 re-usable Powerpoint slides | By ex-Deloitte & McKinsey Consultants | Downloadable at www.slidebooks.com | Includes Tools, Templates, Frameworks, Principles
Presentation given at the BPM Executive Day, Bogota, Colombia, December 4, 2012. The presentation outlines the different dimensions of BPM activities an organization should consider when organizing their BPM efforts.
Solution Architecture and Solution AcquisitionAlan McSweeney
This describes a systematised and structured approach to solution acquisition or procurement that involves solution architecture from the start. This allows the true scope of both the required and subsequently acquired solution are therefore fully understood. By using such an approach, poor solution acquisition outcomes are avoided.
Solution architecture provides the structured approach to capturing all the cost contributors and knowing the true solution scope.
There is more packaged/product/service-based solution acquisition activity. There is an increasing trend of solutions hosted outside the organisation. Meanwhile solution acquisition outcomes are poor and getting worse.
Poor solution acquisition has long-term consequences and costs.
The to-be-acquired solution needs to operate in and co-exist with an existing solution topography and the solution acquisition process needs to be aware of and take account of this wider solution topography. Cloud-based or externally hosted and provided solutions do not eliminate the need for the solution to exist within the organisation solution topography.
Strategic misrepresentation in solution acquisition is the deliberate distortion or falsification of information relating to solution acquisition costs, complexity, required functionality, solution availability, resource availability, time to implement in order to get solution acquisition approval. Strategic misrepresentation is very real and its consequences can be very damaging.
Solution architecture has the skills and experience to define the real scope of the solution being acquired. An effective structured solution acquisition process, well-implemented and consistently applied, means dependable and repeatable solution acquisition and successful outcomes.
Unlock the Value of ITIL 4 with 5 Key Takeaways that can be Used Today!Axios Systems
As ITIL continues to evolve and expand to provide a holistic and integrated view of IT Service Management it is easy to lose sight of the fundamental practices that make day-to-day IT management life sustainable. In this practical webinar, Troy DuMoulin and Ed Perez will look at 5 Key Takeaways any organization can use from ITIL 4 best practices that enable improved service delivery without complex requirements and high levels of process maturity.
Gartner: Seven Building Blocks of Master Data ManagementGartner
Gartner will further examine key trends shaping the future MDM market during the Gartner MDM Summit 2011, 2-3 February in London. More information at www.europe.gartner.com/mdm.
Cloud Migration, Application Modernization and Security for PartnersAmazon Web Services
As AWS continues to expand, enterprise customers are increasingly looking to our partner ecosystem to assist in migrating their workloads to the cloud. This session describes the challenges, lessons learned, and best practices for large-scale application migrations. We will use real examples from our consulting partners and AWS Professional Services to illustrate how to move workloads to the cloud while modernizing the associated applications to take advantage of the unique benefits of AWS. We will also dive into how to use an array of AWS services and features to improve customers' security posture as they migrate and once they are up and running in the cloud.
"You can download this product from SlideTeam.net"
Achieve operational excellence with our creatively designed Continuous Improvement PowerPoint Presentation Slides. This business operational excellence framework presentation deck includes a set of professionally designed PowerPoint templates such as company history of operational excellence capabilities, evaluate the existing operational gaps, design an evaluation process, ensure continuous improvement, implementing regional operations, analytics of achieving operational excellence, monitor performance, etc. Not only this, to cover all the important concepts our designers have included additional templates e.g. our target, mission and vision, timeline, target, thank you, financial charts, etc. Outline the factors that make continuous improvement successful. The process improvement methodology PPT slideshow have all visually appealing graphics with in-depth researched content. Furthermore, with the support of our evaluation process presentation design, you can portray various concepts like strategy deployment, performance management, continuous improvement, organizational excellence, process excellence, leading people and culture, etc. Download the business improvement process presentation deck for evaluation and improving business processes. Increase the inflow with our Continuous Improvement Powerpoint Presentation Slides. Ensure good ideas continue to be generated. https://bit.ly/3BCixJz
Core Banking Transformation: Solutions to Standardize Processes and Cut CostsIBM Banking
IBM Banking Industry Framework for Core Banking Transformation (CBTF) has many assets, tools, methods and accelerators to help banks standardize and link core processes seamlessly and reduce point-to-point interfaces to cut cost and complexity.
Managed IT Services Pricing Models And Strategies Powerpoint Presentation SlidesSlideTeam
"You can download this product from SlideTeam.net"
Presenting Managed IT Services Pricing Models And Strategies PowerPoint Presentation Slides. This complete PPT deck is made up of 40 professional slides. You can convert and save this PowerPoint slideshow in formats like PDF, PNG, and JPG. All the templates are fully customizable. You can edit text, fonts, patterns, colors, and background within seconds. Also, this PPT template deck is compatible with Google Slides. You can view this presentation on standard and widescreen formats. https://bit.ly/36YwIxW
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
Software Testing Process, Testing Automation and Software Testing TrendsKMS Technology
This is the slide deck that KMS Technology's experts shared useful information about latest and greatest achievements of software testing field with lecturers of HCMC University of Industry.
Oil & Gas Technology Solutions on HANA. Akili and Cisco Offer Best in Class Solutions for Upstream Oil & Gas.
Gain Optimal Performance and Accelerated Results with Industry Solutions on HANA.
Applying Technologies Across the End-to-End Pharmacovigilance Process to Incr...MyMeds&Me
MyMeds&Me CEO Andrew Rut and Oracle Health Science's Director of Safety Analytics, Michael Braun-Boghos review the positive impacts of technology on current pharmacovigilance processes.
This presentation presents key findings from LNS Research's yearlong benchmark study of over 500 global quality executives. It details how market leaders are leveraging EQMS software, and makes recommendations for executives looking to learn more or invest in this space.
Helping businesses conduct post-payment audit to recover excess payment from suppliers – through spend analytics and a continuous process improvement to eliminate sources of leakage.
We are a ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, allowing us to offer services at a very competitive price.
Our broad service portfolio, extensive experience, effective project management, and exceptional cost effectiveness, have already proven to be a winning combination for global corporations, as well as small and medium sized companies.
Biotech Resources Group was invited to Qingdao (1hr North of Shanghai) to present on the challenges of biosimilars in China given the need to keep pace with increased commercial demand.
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
Pressure to deliver business value faster, and more efficiently is everywhere. Companies are adopting Agile practices and going though the Agile Transformation because moving to agile methods offers any organization to outperform its former measures of productivity and profits. Several years ago, IBM Software Group began adapting agile software development practices and related products to their needs. This session will provide details where we started and what was our agile journey.
Strategies and Best Practices for Transforming Enterprise TrainingVeeva Systems
Webinar with Carol Benson, associate director of quality systems at Incyte, and Kent Malmros, senior director of Vault Training. They discuss best practices and strategies for successfully transforming learning management systems. There are benefits of starting learning management system selection and implementation with diligent and comprehensive change management approaches.
Topics include:
- Organizational governance strategies for LMS
- How to build on a foundation of GxP compliance
- How to build cross-functional oversight
- Selecting the right learning technologies to eliminate all paper processes
- Best practices for delivering a single system
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.
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
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
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
Reshaping Global ICSR Reporting to Deliver Real-time Visibility and OversightVeeva Systems
Learn how you can reshape global ICSR reporting to deliver real-time visibility and oversight.
In this presentation we discuss:
- Challenges and approaches to safety data management and ICRS reporting
- How technology is making it easier to comply with global and regional requirements
- Considerations for incorporating affiliates into one pharmacovigilance solution
- Strategies for adopting a single multi-lingual safety solution
View the on-demand webinar here: https://bit.ly/35Pfyik
Tufts Research: EDC Trends, Insights, and OpportunitiesVeeva Systems
Watch the video here: https://bit.ly/3yIrVu0
New Tufts research on the eClinical landscape
Learn how seemingly minor decisions in one functional group can significantly impact overall clinical trial timelines. Specifically, those who never release the database before first patient, first visit (FPFV) take more than three weeks longer to lock the database than those who always release before FPFV. Other key findings include:
* Types and volume of data companies manage in EDC
* The biggest causes of database build delays
* How sponsor and CRO cycle times compare for database build, data entry, and database lock
Who Will Benefit:
* Data Management
* eClinical
* Clinical Operations
* Biometrics
* Clinical Development
* R&D IT
Tufts Research: Strategies from Data Management Leaders to Speed Clinical TrialsVeeva Systems
Watch the video here: https://bit.ly/3wChmGQ
Learn how top pharmas and CROs plan to speed database build and data collection, as well as their top challenges and future priorities. In this webinar you'll gain insights into:
* Taking an agile approach to database build
* Reducing UAT timelines with a risk-based approach
* Driving innovation at your organization
This in-depth research from Tufts follows their industry-wide eClinical Landscape Study, examining the major cause of database build delays and their impact on trial cycle times.
Meet Your Presenters:
Ken Getz
Director of Sponsored Programs, Tufts CSDD
Richard Young
Vice President, Vault EDC, Veeva Systems
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
Validation strategies for cloud-based EDCs: more innovation, less effortVeeva Systems
Watch the video here: https://bit.ly/2SxsAxO
Validation concerns can hold companies back from adopting innovations in their clinical systems
Validation concerns can hold companies back from adopting the latest innovations in their EDC systems. Differing opinions on the appropriate level of system validation can also add stress within an organization. It is possible to implement new features and stay validated with relatively little effort if you use validation techniques tailored to cloud-based systems.
In this session, we address how to set the right approach, what to expect from a cloud EDC software provider and what you should expect to do as a sponsor or CRO to perform the initial validation and maintain a validated state following subsequent releases.
Who Will Benefit:
* Clinical Data Manager
* Clinical Data Director
* Head of Clinical Data
* Clinical Operations Manager
* Clinical Operations Director
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
Meet Your Presenters:
Natalie Townsend
Senior Solution Consultant, Vault CDMS
As Senior Solution Consultant for Vault CDMS Natalie is responsible for understanding customer challenges and objectives and providing technical product demonstrations tailored to address these needs. Natalie has 16+ years industry experience in designing, implementing and supporting eClinical solutions to address the myriad of challenges faced across biopharmaceutical organizations. Her experience with clinical trials spans a broad range of sponsors and therapeutic areas across all phases and regions, allowing her to appreciate the differing technology considerations and needs.
Tanya du Plessis
Vice President of data strategies and solutions, Bioforum the Data Masters
Tanya is Vice President of data strategies and solutions at Bioforum. She has vast experience across the industry through her current role at Bioforum, as well as the 14 years she spent with IQVIA (legacy Quintiles). Throughout her career, Tanya has worked with multinational pharmaceutical companies as well as small-to-mid size biotechs and startups. She has led various data management operations and programs, heading numerous innovation teams and spearheading the development of strategies for customized data delivery solutions, focusing on timely, quality data. A certified clinical data manager (CCDM, SCDM), Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State in South Africa. She also has a project management professional certification (PMP, PMI).
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.
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.
PICI’s Best Practices for Building Oncology Studies in an EDCVeeva Systems
Watch the video here: https://bit.ly/3vrYslR
The Parker Institute for Cancer Immunotherapy (PICI) runs complex clinical trials that depend on an electronic data capture (EDC) system that is adaptive, flexible and innovating at the same pace as their patient-centric mission.
Learn why their legacy EDC system workarounds and custom functions no longer sustained their business, which motivated them to take a new approach. In this webinar, Toby Odenheim, the Director of Technology and Governance, will share how PICI decided to adopt a new EDC system that streamlines the build process for oncology trials and how they better equip their clinical programmers and data managers. PICI’s lead study builder, Gary Smith, will provide a hands-on perspective and share strategies to handle the key challenges that oncology teams face with EDC systems, including:
* Umbrella trials that evaluate multiple therapies
* Adaptive trial branching and routing
* Having an unknown number of treatment cycles
* Amendments and other unplanned changes
Who Will Benefit:
* Data managers
* Database Programmers
* Clinical Programmers
* Clinical programmers in charge of building studies
* Clinical leaders in charge of selecting EDC systems
* EDC Programmers
Meet Your Presenters:
Toby Odenheim
Director, Technology and Governance, Parker Institute for Cancer Immunotherapy
In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, medical coding, safety, and business intelligence systems.
Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications in finance, Oracle database administration, and relational database design.
Gary Smith
Senior EDC Programmer/Analyst, Parker Institute for Cancer Immunotherapy
Gary has over twenty years of experience in clinical programming and is a subject matter expert on study design, configuration, and testing with off-the-shelf EDC systems including Veeva Vault CDMS, Medidata Rave, and Oracle Clinical. Gary has deep expertise in building oncology studies, specifically platform studies, and is currently responsible for all aspects of EDC design and study builds in immuno-oncology studies with the Parker Institute for Cancer Immunotherapy. Gary has developed global libraries for five different companies, spanning medical device and pharmaceutical industries.
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.
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.
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.
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.
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.
Building a Foundation for Proactive and Predictive PharmacovigilanceVeeva Systems
Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies.
View on-demand session: https://bit.ly/3vIzQG9
Clinlogix - Improving Pharmacovigilance Outsourcing with Modern Technologies Veeva Systems
Learn how pharma companies and vendors are collaborating and simplifying processes with modern safety solutions. View the on-demand webinar here: https://bit.ly/30eAlJC
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
13. PwC
Quality is evolving from a compliance-centric to a product &
patient-centric approach
13
Patient
Centric
Product
Centric
Compliance
Centric
Quality is focused on ensuring effectiveness of treatment,
patient quality-of-life and driving revenue growth
Quality is focused on designing and manufacturing highly
reliable products with highly capable processes and driving
tangible bottom line ROI
Quality is primarily focused on meeting regulatory
requirements and is considered a cost-of-doing business
14. PwC
Organizational
DNA / Culture
Processes &
Procedures
Digital
Quality
Scientific &
Operational
Excellence
This transformation requires a structured approach
14
Quality 4.0 framework
Quality
Outcomes
The 4 Quality
Elements Centered
around the patient
Patient
Centric
Product
Centric
Compliance
Centric
16. PwC
Measuring Quality Outcomes & Business Value
16
Quality
Outcomes
Business Value - Return on Investment (ROI)
Metrics Revenue Costs Inventory Reg. Risk
Competitive
Compliance
Innovation
Speed to
Market
Robust Products
& Data
Reliable
Supply
17. PwC
Measuring Quality Outcomes & Business Value
17
Quality
Outcomes
Business Value - Return on Investment (ROI)
Metrics Revenue Costs Inventory Reg. Risk
Competitive
Compliance
• Culture & Employee Engagement
• Audit & Inspection Observations
• Recall & Deviation Rates
• Supplier Risk Profile
• Total Cost of Quality
Compliance Risk Dashboard
Innovation
• Use of Modern Mfg. Processes & Analytical Automation
• Use of Emerging Technologies (e.g.: AI, Analytics)
• Adoption of Enterprise Quality Systems
• Use of Adaptive Clinical Trial Design
• Use of QbD, QRM, CPV, etc.
Speed to
Market
• LPO – Database Lock & CSR (by study)
• LPO – 1st Major MAA Approval
• Protocol Amendment Rate
• Serious Breach & Critical Data Error Rate
• % Post Approval Changes approved on time
Robust Products
& Data
• Product & Process Knowledge (data)
• Brand Image (Patient perspective)
• Release Cycle Time (& variability)
• Yield, OOS, OOT, OEE, Cpk
• Complaint Rate
Product Quality Dashboard
Reliable
Supply
• E2E Cycle Time (DS, DP, FG, Customer Shipment)
• Manufacturing Schedule Adherence
• Service Levels (on time, in full)
• Shipping-Related Complaints
• % Dual Sourced Supply
Competitive Compliance
• Culture & Employee Engagement
• Audit & Inspection Observations
• Recall & Deviation Rates
• Supplier Risk Profile
• Total Cost of Quality
Compliance Risk Dashboard
Reduces Cost & Regulatory Risk
18. PwC
Measuring Quality Outcomes & Business Value
18
Quality
Outcomes
Business Value - Return on Investment (ROI)
Metrics Revenue Costs Inventory Reg. Risk
Competitive
Compliance
• Culture & Employee Engagement
• Audit & Inspection Observations
• Recall & Deviation Rates
• Supplier Risk Profile
• Total Cost of Quality
Compliance Risk Dashboard
Innovation
• Use of Modern Mfg. Processes & Analytical Automation
• Use of Emerging Technologies (e.g.: AI, Analytics)
• Adoption of Enterprise Quality Systems
• Use of Adaptive Clinical Trial Design
• Use of QbD, QRM, CPV, etc.
Speed to
Market
• LPO – Database Lock & CSR (by study)
• LPO – 1st Major MAA Approval
• Protocol Amendment Rate
• Serious Breach & Critical Data Error Rate
• % Post Approval Changes approved on time
Robust Products
& Data
• Product & Process Knowledge (data)
• Brand Image (Patient perspective)
• Release Cycle Time (& variability)
• Yield, OOS, OOT, OEE, Cpk
• Complaint Rate
Product Quality Dashboard
Reliable
Supply
• E2E Cycle Time (DS, DP, FG, Customer Shipment)
• Manufacturing Schedule Adherence
• Service Levels (on time, in full)
• Shipping-Related Complaints
• % Dual Sourced Supply
Innovation
• Use of Modern Mfg. Processes & Analytical
Automation
• Use of Emerging Technologies (e.g.: AI,
Analytics)
• Adoption of Enterprise Quality Systems
• Use of Adaptive Clinical Trial Design
• Use of QbD, QRM, CPV, etc.
Reduces Cost & Regulatory Risk
19. PwC
Measuring Quality Outcomes & Business Value
19
Quality
Outcomes
Business Value - Return on Investment (ROI)
Metrics Revenue Costs Inventory Reg. Risk
Competitive
Compliance
• Culture & Employee Engagement
• Audit & Inspection Observations
• Recall & Deviation Rates
• Supplier Risk Profile
• Total Cost of Quality
Compliance Risk Dashboard
Innovation
• Use of Modern Mfg. Processes & Analytical Automation
• Use of Emerging Technologies (e.g.: AI, Analytics)
• Adoption of Enterprise Quality Systems
• Use of Adaptive Clinical Trial Design
• Use of QbD, QRM, CPV, etc.
Speed to
Market
• LPO – Database Lock & CSR (by study)
• LPO – 1st Major MAA Approval
• Protocol Amendment Rate
• Serious Breach & Critical Data Error Rate
• % Post Approval Changes approved on time
Robust Products
& Data
• Product & Process Knowledge (data)
• Brand Image (Patient perspective)
• Release Cycle Time (& variability)
• Yield, OOS, OOT, OEE, Cpk
• Complaint Rate
Product Quality Dashboard
Reliable
Supply
• E2E Cycle Time (DS, DP, FG, Customer Shipment)
• Manufacturing Schedule Adherence
• Service Levels (on time, in full)
• Shipping-Related Complaints
• % Dual Sourced Supply
Speed to Market
• LPO- Database Lock & CSR (by study)
• LPO-1st Major MAA Approval
• Protocol Amendment Rate
• Serious Breach & Critical Data Error Rate
• % Post Approval Changes approved on
time
Increases Revenue
20. PwC
Measuring Quality Outcomes & Business Value
20
Quality
Outcomes
Business Value - Return on Investment (ROI)
Metrics Revenue Costs Inventory Reg. Risk
Competitive
Compliance
• Culture & Employee Engagement
• Audit & Inspection Observations
• Recall & Deviation Rates
• Supplier Risk Profile
• Total Cost of Quality
Compliance Risk Dashboard
Innovation
• Use of Modern Mfg. Processes & Analytical Automation
• Use of Emerging Technologies (e.g.: AI, Analytics)
• Adoption of Enterprise Quality Systems
• Use of Adaptive Clinical Trial Design
• Use of QbD, QRM, CPV, etc.
Speed to
Market
• LPO – Database Lock & CSR (by study)
• LPO – 1st Major MAA Approval
• Protocol Amendment Rate
• Serious Breach & Critical Data Error Rate
• % Post Approval Changes approved on time
Robust Products
& Data
• Product & Process Knowledge (data)
• Brand Image (Patient perspective)
• Release Cycle Time (& variability)
• Yield, OOS, OOT, OEE, Cpk
• Complaint Rate
Product Quality Dashboard
Reliable
Supply
• E2E Cycle Time (DS, DP, FG, Customer Shipment)
• Manufacturing Schedule Adherence
• Service Levels (on time, in full)
• Shipping-Related Complaints
• % Dual Sourced Supply
Robust Products & Data
• Product & Process Knowledge (data)
• Brand Image (Patient perspective)
• Release Cycle Time (& variability)
• Yield, OOS, OOT, OEE, Cpk
• Complaint Rate
Product Quality Dashboard
Increases Revenue, Reduces Cost,
Inventory & Regulatory Risk
21. PwC
Measuring Quality Outcomes & Business Value
21
Quality
Outcomes
Business Value - Return on Investment (ROI)
Metrics Revenue Costs Inventory Reg. Risk
Competitive
Compliance
• Culture & Employee Engagement
• Audit & Inspection Observations
• Recall & Deviation Rates
• Supplier Risk Profile
• Total Cost of Quality
Compliance Risk Dashboard
Innovation
• Use of Modern Mfg. Processes & Analytical Automation
• Use of Emerging Technologies (e.g.: AI, Analytics)
• Adoption of Enterprise Quality Systems
• Use of Adaptive Clinical Trial Design
• Use of QbD, QRM, CPV, etc.
Speed to
Market
• LPO – Database Lock & CSR (by study)
• LPO – 1st Major MAA Approval
• Protocol Amendment Rate
• Serious Breach & Critical Data Error Rate
• % Post Approval Changes approved on time
Robust Products
& Data
• Product & Process Knowledge (data)
• Brand Image (Patient perspective)
• Release Cycle Time (& variability)
• Yield, OOS, OOT, OEE, Cpk
• Complaint Rate
Product Quality Dashboard
Reliable
Supply
• E2E Cycle Time (DS, DP, FG, Customer Shipment)
• Manufacturing Schedule Adherence
• Service Levels (on time, in full)
• Shipping-Related Complaints
• % Dual Sourced Supply
Reliable Supply
• E2E Cycle Time (DS, DP, FG, Customer
shipment)
• Manufacturing Schedule Adherence
• Service Levels (on time, in full)
• Shipping- Related Complaints
• % Dual Sourced Supply
Increases Revenue
& Reduces Inventory
22. PwC
Measuring Quality Outcomes & Business Value
22
Quality
Outcomes
Business Value - Return on Investment (ROI)
Metrics Revenue Costs Inventory Reg. Risk
Competitive
Compliance
• Culture & Employee Engagement
• Audit & Inspection Observations
• Recall & Deviation Rates
• Supplier Risk Profile
• Total Cost of Quality
Compliance Risk Dashboard
Innovation
• Use of Modern Mfg. Processes & Analytical Automation
• Use of Emerging Technologies (e.g.: AI, Analytics)
• Adoption of Enterprise Quality Systems
• Use of Adaptive Clinical Trial Design
• Use of QbD, QRM, CPV, etc.
Speed to
Market
• LPO – Database Lock & CSR (by study)
• LPO – 1st Major MAA Approval
• Protocol Amendment Rate
• Serious Breach & Critical Data Error Rate
• % Post Approval Changes approved on time
Robust Products
& Data
• Product & Process Knowledge (data)
• Brand Image (Patient perspective)
• Release Cycle Time (& variability)
• Yield, OOS, OOT, OEE, Cpk
• Complaint Rate
Product Quality Dashboard
Reliable
Supply
• E2E Cycle Time (DS, DP, FG, Customer Shipment)
• Manufacturing Schedule Adherence
• Service Levels (on time, in full)
• Shipping-Related Complaints
• % Dual Sourced Supply
23. PwC
Quality
Outcomes
Business Value - Return on Investment (ROI)
Revenue Costs Inventory Reg. Risk
Competitive
Compliance
Innovation
Speed to
Market
Robust Products
& Data
Reliable
Supply
Calculating the Business Value (ROI)
23
Potential ROI for a $10 B Company
1% increase in revenue $100 M
25% reduction in cost of quality* $75 - 125 M
Total annual benefit $175 - 225 M
Market Capitalization @ 10x PE ratio $1.75 – 2.25 B
10% improvement in inventory turns** $90 M
Cost avoidance of Warning Letter***
Cost avoidance of Consent Decree
$5 - 50 M
$ .2 – 2 B
* Cost of quality is typically 3-5% of revenue, a 25% reduction equals 1-2% of revenue
** Increasing turns from 2 to 2.2 on COGS of 20% of revenue for a 1 time free cash flow
*** PWC Estimates (including cost of remediation, cost of QMS transformation, lost revenue)
24. PwC
Quality
Outcomes
Business Value - Return on Investment (ROI)
Revenue Costs Inventory Reg. Risk
Competitive
Compliance
Innovation
Speed to
Market
Robust Products
& Data
Reliable
Supply
Calculating the Business Value (ROI)
24
Potential ROI for a $10 B Company
1% increase in revenue $100 M
25% reduction in cost of quality* $75 - 125 M
Total annual benefit $175 - 225 M
Market Capitalization @ 10x PE ratio $1.75 – 2.25 B
10% improvement in inventory turns** $90 M
Cost avoidance of Warning Letter***
Cost avoidance of Consent Decree
$5 - 50 M
$ .2 – 2 B
* Cost of quality is typically 3-5% of revenue, a 25% reduction equals 1-2% of revenue
** Increasing turns from 2 to 2.2 on COGS of 20% of revenue for a 1 time free cash flow
*** PWC Estimates (including cost of remediation, cost of QMS transformation, lost revenue)
25. PwC
The value of an integrated QMS
25
Quality
Outcomes
Business Value - Return on Investment (ROI)
Revenue Costs Inventory Reg. Risk
Competitive
Compliance
Innovation
Speed to
Market
Robust Products
& Data
Reliable
Supply
Reduced product withdrawals
Introduction of new technologies (e.g.: gene therapy)
Faster product approvals & launches (LPO to Filing)
Brand reputation in developing markets
More robust clinical studies and data
Improved tender win rates
Reduced product shortages
Fulfill unexpected increases in demand
Revenue
26. PwC
The value of an integrated QMS
26
Quality
Outcomes
Business Value - Return on Investment (ROI)
Revenue Costs Inventory Reg. Risk
Competitive
Compliance
Innovation
Speed to
Market
Robust Products
& Data
Reliable
Supply
Total Cost of eQMS / eDMS Ownership
Reduction in # of deviations, CAPAs & recalls
Reduction in Operations and QA headcount
Reduction in hours on training
Reduction in serious breaches
Reduction in protocol amendments
Improved yields, Right First Time, OEE, Cpk
Reduction in # of complaints
Reduced capital expenditures
Cost
27. PwC
The value of an integrated QMS
27
Quality
Outcomes
Business Value - Return on Investment (ROI)
Revenue Costs Inventory Reg. Risk
Competitive
Compliance
Innovation
Speed to
Market
Robust Products
& Data
Reliable
Supply
In line, reduced testing reqs., modern / rapid testing technologies
Shorter E2E cycle time from RM, API, DP, Packaged product in
country available for sale
Reduced testing, disposition LT, processing at risk, QP in country
Inventory
28. PwC
The value of an integrated QMS
28
Quality
Outcomes
Business Value - Return on Investment (ROI)
Revenue Costs Inventory Reg. Risk
Competitive
Compliance
Innovation
Speed to
Market
Robust Products
& Data
Reliable
Supply
Reduction in Risk profile
Reduced # of inspection days & findings
Self identified improvement opportunities
Reg. Risk
29. PwC
The value of an integrated QMS
29
Quality
Outcomes
Business Value - Return on Investment (ROI)
Revenue Costs Inventory Reg. Risk
Competitive
Compliance
• Reduced product withdrawals • Total Cost of eQMS / eDMS
Ownership
• Reduction in Operations and
QA costs
• Reduction in # of deviations,
CAPAs & recalls
• Reduction in Risk profile
• Reduced number of inspection
days & findings
Innovation
• Introduction of new technologies
(e.g.: gene therapy)
• Reduction in hours on training • In line testing, reduced testing
requirements, modern / rapid
testing technologies, etc.
• Self identified improvement
opportunities
Speed to
Market
• Faster product approvals &
launches (LPO to Filing)
• Reduction in serious breaches
• Reduction in protocol
amendments
Robust Products
& Data
• Brand reputation in developing
markets
• More robust clinical studies and
data
• Improved tender win rates
• Improved yields
• Improved Right First Time
• Improved OEE, Cpk
• Reduction in # of complaints
• Reduced capital expenditures
Reliable
Supply
• Reduced product shortages
• Fulfill unexpected increases in
demand
• Shorter E2E cycle time from RM,
API, DP, Packaged product in
country available for sale
• Reduced testing, disposition LT,
processing at risk, QP in country
30. PwC
The value of an integrated QMS – Total Cost of Ownership
30
Quality
Outcomes
Business Value - Return on Investment (ROI)
Revenue Costs Inventory Reg. Risk
Competitive
Compliance
• Total Cost of eQMS / eDMS
Ownership
Innovation
Speed to
Market
Robust Products
& Data
Reliable
Supply
31. PwC
The Value of an Integrated QMS – Cost Reduction
31
Quality
Outcomes
Business Value - Return on Investment (ROI)
Revenue Costs Inventory Reg. Risk
Competitive
Compliance
• Total Cost of eQMS / eDMS
Ownership
• Reduction in Operations and
QA costs
Innovation
Speed to
Market
Robust Products
& Data
Reliable
Supply
32. PwC
CxO Talking Points
Talking the language of the CxO
32
Improving the brand imageCEO
COO
CFO
CCO
CQO
CSO
Robustness of processes & products
Improved yields & cycle times
Reduction in overall cost of (poor) quality
Total cost of ownership for eQMS / eDMS
Speed to market & reliability of supply
Competitive Compliance
Higher compliance at reduced cost
Reduced # of Protocol Deviations & Amendments
Robustness & speed of clinical trials & approvals
(Commercial)
(Quality)
(Science)
(Finance)
(Operation)
(Executive)
Building a Business Case for Quality Management Transformation
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.
Join us on Wednesday, July 17 for a live 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
The first slide should setup the industry drivers of why the first wave of industry adoption occurred
It should have the context set that this was over a continuum of time from late 90’s until recent times. We could use a visual for this.
Perhaps more of the real estate on the slide is a set of visuals that sequence in from left to right to set up these points.
Emergence of 21 CFR Part 11
Necessity of replacing home grown applications & manual processes
Remediation of plant and line of business specific compliance challenges
Fragmented IT strategy --- quality systems not yet recognized as strategic
Left is what is happening and the right is the impact / challenge
This is the transition to the investment piece
There should be two points, point one is sum of many smaller incremental projects over a period of 20 years setup in the last slide,
the second point is the reality of cyclical investment that is based on compliance issues and individualized investments.
This could potentially be one visual that covers both.
New slide ---- What is different today
Large transformative investments, singular implementations, not incremental overtime
Many companies have never built business cases for singular, enterprise projects of this scope in the quality area
True shifts to the cloud have a significantly different TCO footprint. Large amount of cost is
Great opportunity for creating value --- not just achieving compliance
This requires different thinking when it comes to building a business case
--- cloud alternatives now exist and are being actively implemented, offer a transformative set of benefits vs. the legacy in place --- we may want to share market observations x/y top N companies engaging in transformative projects
2nd slide --- talk about how this is categorically different then the past
---large transformative implementations, not reactive to regulatory challenges but more positioned to deliver value to the business --- value driven, not drive by necessity of compliance or quality
Enumerate cloud benefits ---- 3 releases per year, industry cloud notion of best practices across multiple dimensions, unification in and out of quality, standardization of process, integration of third parties
Cloud
All QMS elements brought together into a single system with standardized processes and data model
Unification of disparate quality applications onto a single platform
Interconnections between applications are standardized and maintained
Exciting time to create value and transform quality management
Larger transformative topics