This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017April Bright
This document provides an overview of global regulatory trends in 2017 and beyond for medical devices. Key points include increased emphasis on clinical data and post-market surveillance across regions. The EU is transitioning to the new Medical Device Regulation which increases requirements for technical documentation and quality management systems. Notified Bodies face challenges meeting demand under new rules. The US 21st Century Cures Act aims to streamline approval of certain lower-risk devices and accessories. Single audits through the Medical Device Single Audit Program may replace some regulatory inspections globally.
ISO 13485:2016 Transition Are You Prepared - OMTEC 2017April Bright
ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017April Bright
Computational modeling and simulation (CM&S) has the potential to revolutionize medical devices by accelerating innovation and providing comprehensive evidence of long-term safety. For example, CM&S can provide performance benchmarks, assess design parameter interdependencies, evaluate a variety of use conditions, provide visualization of complex processes and become a core element of device submissions and approvals. This presentation will begin with an overview of the use of CM&S throughout the orthopaedic implant lifecycle, followed by a review of the current regulatory direction regarding the use of CM&S in device submissions. Next, a series of case studies based on a variety of orthopaedic implants will demonstrate the application of CM&S at various phases of the product lifecycle in more detail. The examples will also highlight the effects of modeling assumptions on model credibility and some verification and validation best practices.
This presentation will position CM&S as a credible and common means for device companies and FDA to demonstrate the safety of medical devices, and thereby ensure safety, reduce cost and accelerate the pathway toward “first in the world” access to products in the U.S.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
The Medical Device Single Audit Program (MDSAP) is an initiative by the International Medical Device Regulators Forum (IMDRF) to develop a harmonized audit program that allows medical device manufacturers to undergo a single regulatory audit to satisfy the requirements of multiple regulatory jurisdictions. The MDSAP pilot program began in 2014 and involves regulators from the US, Canada, Brazil, Australia and Japan. It aims to recognize third-party auditing organizations to conduct audits of medical device manufacturers according to a standardized audit process, with the goal of facilitating medical device trade while ensuring public health and safety.
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...April Bright
Product launch is not the time to start securing reimbursement for your device. Reimbursement remains a complex process for orthopaedic companies that could be lessened if properly aligned throughout commercialization. Mr. Hunter shares the who, what and when of reimbursement to ensure that you’ve received proper coverage prior to launch.
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
How to Assess New Technology - OMTEC 2017April Bright
Creating robust product pipelines is a top priority for most global orthopaedic device companies, yet our industry’s commercial success rate for new product launches remains less than 20%. Traditionally one of the largest contributors to the less-than-stellar success rate is failure in the very first steps of the development process: a new technology assessment. We will examine the ways that companies address challenges associated with new technology assessments, and some of the key lessons learned.
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017April Bright
This document provides an overview of global regulatory trends in 2017 and beyond for medical devices. Key points include increased emphasis on clinical data and post-market surveillance across regions. The EU is transitioning to the new Medical Device Regulation which increases requirements for technical documentation and quality management systems. Notified Bodies face challenges meeting demand under new rules. The US 21st Century Cures Act aims to streamline approval of certain lower-risk devices and accessories. Single audits through the Medical Device Single Audit Program may replace some regulatory inspections globally.
ISO 13485:2016 Transition Are You Prepared - OMTEC 2017April Bright
ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017April Bright
Computational modeling and simulation (CM&S) has the potential to revolutionize medical devices by accelerating innovation and providing comprehensive evidence of long-term safety. For example, CM&S can provide performance benchmarks, assess design parameter interdependencies, evaluate a variety of use conditions, provide visualization of complex processes and become a core element of device submissions and approvals. This presentation will begin with an overview of the use of CM&S throughout the orthopaedic implant lifecycle, followed by a review of the current regulatory direction regarding the use of CM&S in device submissions. Next, a series of case studies based on a variety of orthopaedic implants will demonstrate the application of CM&S at various phases of the product lifecycle in more detail. The examples will also highlight the effects of modeling assumptions on model credibility and some verification and validation best practices.
This presentation will position CM&S as a credible and common means for device companies and FDA to demonstrate the safety of medical devices, and thereby ensure safety, reduce cost and accelerate the pathway toward “first in the world” access to products in the U.S.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
The Medical Device Single Audit Program (MDSAP) is an initiative by the International Medical Device Regulators Forum (IMDRF) to develop a harmonized audit program that allows medical device manufacturers to undergo a single regulatory audit to satisfy the requirements of multiple regulatory jurisdictions. The MDSAP pilot program began in 2014 and involves regulators from the US, Canada, Brazil, Australia and Japan. It aims to recognize third-party auditing organizations to conduct audits of medical device manufacturers according to a standardized audit process, with the goal of facilitating medical device trade while ensuring public health and safety.
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...April Bright
Product launch is not the time to start securing reimbursement for your device. Reimbursement remains a complex process for orthopaedic companies that could be lessened if properly aligned throughout commercialization. Mr. Hunter shares the who, what and when of reimbursement to ensure that you’ve received proper coverage prior to launch.
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
How to Assess New Technology - OMTEC 2017April Bright
Creating robust product pipelines is a top priority for most global orthopaedic device companies, yet our industry’s commercial success rate for new product launches remains less than 20%. Traditionally one of the largest contributors to the less-than-stellar success rate is failure in the very first steps of the development process: a new technology assessment. We will examine the ways that companies address challenges associated with new technology assessments, and some of the key lessons learned.
The document discusses upcoming changes to regulatory requirements for medical devices, including:
1) The MDSAP program which allows a single audit to satisfy multiple regulators like FDA, EU, Japan, Australia. Major auditing organizations have been recognized to conduct MDSAP audits.
2) Revisions to ISO 13485:2016 including greater risk focus, regulatory linkage, and design/development changes. Manufacturers must transition to the new standard by March 2019.
3) Changes to the MEDDEV 2.7.1 clinical evaluation guidance including more frequent evaluations based on risk class and new requirements for team qualifications and establishing state of the art.
4) The upcoming EU Medical Device Regulation which replaces the Medical
ISO 13485 outlines quality management system requirements for medical device manufacturers. It requires organizations to establish documented processes for planning and managing key activities like risk management, product realization, and quality improvement. Records must be maintained to demonstrate conformity to standards. Management is responsible for ensuring adequate resources, communication of quality policies, and regular reviews of the quality system and opportunities for improvement.
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
Packaging Solutions that Improve Time to MarketApril Bright
This session will discuss packaging solutions designed to improve time to market and lower costs for OEMs. Kelly Lucenti will discuss challenges imposed from the research and development phase to production, as well as trending issues with packaging design and validations. The presentation will highlight the importance of OEMs engaging their packaging groups early in the design phase, and ways that leveraging existing validations can speed time to market and cut major costs.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
Design Controls: Building Objective Evidence and Process Architecture to Mee...April Bright
This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
How Design Controls & Risk Management Best Practices Reduce Customer Complain...Greenlight Guru
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
QMS Effectiveness: Tracking and Trending Quality Data - OMTEC 2017April Bright
What measurements are useful, and which metrics’ baseline makes sense to show the effectiveness of your quality management system? This presentation takes an ISO 13485 and 21 CFR, Part 820 approach to deciding what measurements are important, how trending makes an impact on risk-based decision-making, and why management review is just one of the ways to discuss and document your Quality Data activities.
FDA Inspections are Different from ISO Audits, So Don't Treat Them the Same -...April Bright
ISO audits and FDA inspections differ logistically, and should be approached in different manners. This presentation will explain the real-time differences between the two and, most importantly, give you strategies for preparation, behavioral tips for success during and after the assessments and recommendations for responding to the Registrar or FDA if deficiencies were discovered.
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning LettersGreenlight Guru
How long has it been since your last FDA inspection?
You know FDA is technically mandated to inspect any company with class II or class III products every two years (and inspections have been on the rise particularly for foreign / outside the US firms).
If FDA called tomorrow to announce their plans to visit your facility next week would you be prepared?
Even the most prepared companies still often find themselves receiving 483 observations.
Then you must act swiftly and effectively to avoid that observation escalating to a warning letter.
But what exactly do you do?
How do you respond to FDA 483 observations and/or warning letters?
greenlight.guru founder and VP QA/RA, Jon Speer, has been through his fair share of FDA inspections over the course of his 17+ year career in the medical device industry and has helped many of companies respond to 483 observations and warning letters along the way.
In this free, 60 minutes webinar, Jon will be sharing his most effective tips on how to avoid 483’s and warning letters in the first place along with a step-by-step guide to responding the them if you do happen to receive either.
(You can view the full webinar here: http://www.greenlight.guru/webinar/fda-483-warning-letter-response)
Specifically you'll learn:
What you should be doing to always be prepared for an FDA inspection
How to help prep your team before an FDA inspection
The top 7 reasons FDA issued medical device companies 483 observations and warning letters in FY2015
Tips you can implement today to mitigate your risk of getting 483’s and warning letters
What you need to do before responding to a 483 to minimize the damage (and avoid the common pitfalls)
Best practices for responding to FDA 483 and warning letter (including a free response template)
The differences in responding to a 483 observation vs. a warning letter
What to expect from FDA after submitting your response
Difference between fda 21 cfr part 820 and ISO 13485Anil Chaudhari
The document compares FDA 21 CFR Part 820 and ISO 13485 quality management standards. ISO 13485 is an international voluntary standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and services that consistently meet regulatory requirements. In contrast, FDA 21 CFR Part 820 outlines current good manufacturing practice regulations in the US that govern the design, manufacture, and distribution of medical devices to ensure safety and effectiveness. Key differences include ISO 13485 being a global voluntary standard while FDA 21 CFR Part 820 is mandatory for medical device manufacturers selling products in the US.
Epitome Technologies provides compliance solutions and computer system validation services to the life sciences industry. It has over a decade of experience in this field and clients across India and other regions. The company is located in Western India and is headed by experienced professionals including engineers and pharmacists. Epitome helps clients with initial validation of computer systems as well as ongoing maintenance and periodic reviews to ensure compliance with regulations from agencies such as US FDA, EU, and others. Its services include validation documentation, testing, and ensuring computer systems meet quality standards and regulatory requirements for electronic records over the lifetime of the systems.
Accelerating Post-approval Change Management with ICH Q12Veeva Systems
Adopting ICH Q12 and modern technologies can reduce the number of changes that require regulatory approval as well as accelerate evaluation, implementation, and global approval of a change. In a 2017 PDA survey, almost 40% of respondents said that 50% or more of their post-approval changes required submission to a health authority. With increasing complexity in the manufacturing of new therapies and growing number of changes that require filing review and updates in multiple markets, the global post-approval change management (PACM) process is becoming unmanageable.
Modern technologies are reducing complexity in pharma by bringing together systems and people to seamlessly support global, end-to-end processes. With greater visibility and collaboration, change management processes are more efficient and less risky. In this webinar, learn:
What is ICH Q12 and potential benefits
Best practices and approaches to key PACM challenges
Approaches to manage ‘established conditions’
How technology can support ICH Q12 and simplify change management
Innovative ways leading pharma companies are addressing PACM
EMMA International Consulting Group provides quality, regulatory, and compliance consulting services for life sciences companies. They specialize in quality management systems for software as a medical device (SaMD). This document summarizes key topics regarding establishing and maintaining a quality management system for SaMD, including software design controls, post-market activities like software maintenance and changes, regulatory clearance of changes, and recalls. It provides an overview of relevant standards and FDA requirements.
The document discusses GMP compliance audits. It defines GMP audits as a process to verify that manufacturers follow good manufacturing practices regulations. There are two types of audits - onsite audits, which involve visiting the production site, and desktop audits, which review documentation without a site visit. Audits check various aspects of production including personnel, facilities, equipment, processes, warehousing and more. They help identify issues, ensure proper controls, and improve compliance.
Maetrics: The ROI of Good Quality & ComplianceGeneris
The document discusses investing in quality and compliance programs to justify costs. It outlines how to quantify direct and indirect quality costs, examines the FDA's increasing focus on medical devices, and explores the impacts of non-compliance. Proactive quality systems can reduce costs compared to reactive systems. Good investments include dedicated CAPA resources, risk management programs, quality metrics, and harmonizing quality systems during acquisitions.
A CAPA (corrective and preventative action) program is an important indicator of a company's overall compliance efforts. It is considered a "bellwether" by the FDA. An effective CAPA program follows a closed-loop process to identify, correct, and eliminate quality issues and potential problems. It analyzes multiple sources of quality data. Failing to properly establish and maintain CAPA procedures is a common violation cited by the FDA. Ensuring a strong CAPA program that satisfies regulations like ISO 13485 and 21 CFR Part 820 can help reduce compliance risks during FDA inspections.
The document discusses upcoming changes to regulatory requirements for medical devices, including:
1) The MDSAP program which allows a single audit to satisfy multiple regulators like FDA, EU, Japan, Australia. Major auditing organizations have been recognized to conduct MDSAP audits.
2) Revisions to ISO 13485:2016 including greater risk focus, regulatory linkage, and design/development changes. Manufacturers must transition to the new standard by March 2019.
3) Changes to the MEDDEV 2.7.1 clinical evaluation guidance including more frequent evaluations based on risk class and new requirements for team qualifications and establishing state of the art.
4) The upcoming EU Medical Device Regulation which replaces the Medical
ISO 13485 outlines quality management system requirements for medical device manufacturers. It requires organizations to establish documented processes for planning and managing key activities like risk management, product realization, and quality improvement. Records must be maintained to demonstrate conformity to standards. Management is responsible for ensuring adequate resources, communication of quality policies, and regular reviews of the quality system and opportunities for improvement.
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
Packaging Solutions that Improve Time to MarketApril Bright
This session will discuss packaging solutions designed to improve time to market and lower costs for OEMs. Kelly Lucenti will discuss challenges imposed from the research and development phase to production, as well as trending issues with packaging design and validations. The presentation will highlight the importance of OEMs engaging their packaging groups early in the design phase, and ways that leveraging existing validations can speed time to market and cut major costs.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
Design Controls: Building Objective Evidence and Process Architecture to Mee...April Bright
This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
How Design Controls & Risk Management Best Practices Reduce Customer Complain...Greenlight Guru
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
QMS Effectiveness: Tracking and Trending Quality Data - OMTEC 2017April Bright
What measurements are useful, and which metrics’ baseline makes sense to show the effectiveness of your quality management system? This presentation takes an ISO 13485 and 21 CFR, Part 820 approach to deciding what measurements are important, how trending makes an impact on risk-based decision-making, and why management review is just one of the ways to discuss and document your Quality Data activities.
FDA Inspections are Different from ISO Audits, So Don't Treat Them the Same -...April Bright
ISO audits and FDA inspections differ logistically, and should be approached in different manners. This presentation will explain the real-time differences between the two and, most importantly, give you strategies for preparation, behavioral tips for success during and after the assessments and recommendations for responding to the Registrar or FDA if deficiencies were discovered.
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning LettersGreenlight Guru
How long has it been since your last FDA inspection?
You know FDA is technically mandated to inspect any company with class II or class III products every two years (and inspections have been on the rise particularly for foreign / outside the US firms).
If FDA called tomorrow to announce their plans to visit your facility next week would you be prepared?
Even the most prepared companies still often find themselves receiving 483 observations.
Then you must act swiftly and effectively to avoid that observation escalating to a warning letter.
But what exactly do you do?
How do you respond to FDA 483 observations and/or warning letters?
greenlight.guru founder and VP QA/RA, Jon Speer, has been through his fair share of FDA inspections over the course of his 17+ year career in the medical device industry and has helped many of companies respond to 483 observations and warning letters along the way.
In this free, 60 minutes webinar, Jon will be sharing his most effective tips on how to avoid 483’s and warning letters in the first place along with a step-by-step guide to responding the them if you do happen to receive either.
(You can view the full webinar here: http://www.greenlight.guru/webinar/fda-483-warning-letter-response)
Specifically you'll learn:
What you should be doing to always be prepared for an FDA inspection
How to help prep your team before an FDA inspection
The top 7 reasons FDA issued medical device companies 483 observations and warning letters in FY2015
Tips you can implement today to mitigate your risk of getting 483’s and warning letters
What you need to do before responding to a 483 to minimize the damage (and avoid the common pitfalls)
Best practices for responding to FDA 483 and warning letter (including a free response template)
The differences in responding to a 483 observation vs. a warning letter
What to expect from FDA after submitting your response
Difference between fda 21 cfr part 820 and ISO 13485Anil Chaudhari
The document compares FDA 21 CFR Part 820 and ISO 13485 quality management standards. ISO 13485 is an international voluntary standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and services that consistently meet regulatory requirements. In contrast, FDA 21 CFR Part 820 outlines current good manufacturing practice regulations in the US that govern the design, manufacture, and distribution of medical devices to ensure safety and effectiveness. Key differences include ISO 13485 being a global voluntary standard while FDA 21 CFR Part 820 is mandatory for medical device manufacturers selling products in the US.
Epitome Technologies provides compliance solutions and computer system validation services to the life sciences industry. It has over a decade of experience in this field and clients across India and other regions. The company is located in Western India and is headed by experienced professionals including engineers and pharmacists. Epitome helps clients with initial validation of computer systems as well as ongoing maintenance and periodic reviews to ensure compliance with regulations from agencies such as US FDA, EU, and others. Its services include validation documentation, testing, and ensuring computer systems meet quality standards and regulatory requirements for electronic records over the lifetime of the systems.
Accelerating Post-approval Change Management with ICH Q12Veeva Systems
Adopting ICH Q12 and modern technologies can reduce the number of changes that require regulatory approval as well as accelerate evaluation, implementation, and global approval of a change. In a 2017 PDA survey, almost 40% of respondents said that 50% or more of their post-approval changes required submission to a health authority. With increasing complexity in the manufacturing of new therapies and growing number of changes that require filing review and updates in multiple markets, the global post-approval change management (PACM) process is becoming unmanageable.
Modern technologies are reducing complexity in pharma by bringing together systems and people to seamlessly support global, end-to-end processes. With greater visibility and collaboration, change management processes are more efficient and less risky. In this webinar, learn:
What is ICH Q12 and potential benefits
Best practices and approaches to key PACM challenges
Approaches to manage ‘established conditions’
How technology can support ICH Q12 and simplify change management
Innovative ways leading pharma companies are addressing PACM
EMMA International Consulting Group provides quality, regulatory, and compliance consulting services for life sciences companies. They specialize in quality management systems for software as a medical device (SaMD). This document summarizes key topics regarding establishing and maintaining a quality management system for SaMD, including software design controls, post-market activities like software maintenance and changes, regulatory clearance of changes, and recalls. It provides an overview of relevant standards and FDA requirements.
The document discusses GMP compliance audits. It defines GMP audits as a process to verify that manufacturers follow good manufacturing practices regulations. There are two types of audits - onsite audits, which involve visiting the production site, and desktop audits, which review documentation without a site visit. Audits check various aspects of production including personnel, facilities, equipment, processes, warehousing and more. They help identify issues, ensure proper controls, and improve compliance.
Maetrics: The ROI of Good Quality & ComplianceGeneris
The document discusses investing in quality and compliance programs to justify costs. It outlines how to quantify direct and indirect quality costs, examines the FDA's increasing focus on medical devices, and explores the impacts of non-compliance. Proactive quality systems can reduce costs compared to reactive systems. Good investments include dedicated CAPA resources, risk management programs, quality metrics, and harmonizing quality systems during acquisitions.
A CAPA (corrective and preventative action) program is an important indicator of a company's overall compliance efforts. It is considered a "bellwether" by the FDA. An effective CAPA program follows a closed-loop process to identify, correct, and eliminate quality issues and potential problems. It analyzes multiple sources of quality data. Failing to properly establish and maintain CAPA procedures is a common violation cited by the FDA. Ensuring a strong CAPA program that satisfies regulations like ISO 13485 and 21 CFR Part 820 can help reduce compliance risks during FDA inspections.
Insights and Trends from 2021 FDA GCP Inspections.pptxMMS Holdings
The document summarizes insights and trends from the FDA's 2021 GCP inspections. It provides an overview of total inspections, top 483 observations for drugs and devices, and warning letters. Key findings include COVID-19 reducing inspections and alternative tools being used, top drug and device 483 observations relating to documentation and procedures, and most warning letters issued in March and October relating to drugs. It also discusses anticipated changes from the draft ICH E6(R3) guideline and trends for 2022, such as a potential increase in enforcement and focus on data security, quality controls, and corrective actions.
This ppt consists of types of FDA inspection, and how to prepare for FDA inspection of pharmaceutical mfg site, and what to do before FDA inspection, During FDA inspection, and after FDA inspection.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines key terms like process validation, cleaning validation, and maximum allowable carryover. It describes the importance of validation in assuring quality and reducing costs. The document outlines the various stages of validation including process design, qualification, and continuous verification. It emphasizes that validation is an ongoing process to demonstrate consistency. Key aspects that must be addressed in a validation program are also summarized such as personnel training, change control procedures, and documentation.
The document discusses implementing an effective quality management system (QMS) and overcoming challenges with current systems. It outlines regulations around corrective and preventive action (CAPA) from ISO, FDA and EU directives. Traditional QMS have challenges with problem identification, investigation, planning, implementation, and review/approval of CAPAs. The solution proposed is a holistic approach to quality management using a quality management software solution to address these challenges and obtain full regulatory compliance through continuous improvement.
This document discusses corrective and preventive action (CAPA) basics, including:
- The purpose of CAPA is to identify and address quality problems and prevent recurrence.
- Regulations require manufacturers to establish CAPA procedures, collect and analyze data, investigate issues, identify and validate corrective/preventive actions, and document activities.
- The level of CAPA should be appropriate to the risk level of the problem. Relevant information must be communicated and submitted for management review.
validation is a technique of validating the final product either starting from the raw material or within the process, its all types cover the methods of validation and sequence in the product development.
Medical Device Registration in India_ A Comprehensive Guide.pdfPranshuCorpseed
The dynamic landscape of healthcare, the regulatory framework governing medical devices plays a pivotal role in ensuring the safety, efficacy, and quality of products in the market.
This document provides an introduction to quality management systems (QMS), ISO 9001:2015, and IATF 16949:2016 standards. It discusses the basics of a QMS and highlights key changes between versions of the ISO 9001 and IATF 16949 standards. The document outlines the contents to be covered, including introductions to quality documentation, processes, risk analysis methods like PDCA and fishbone diagrams. It also introduces the key standards organizations IATF, IAOB, and AIAG and their purposes in developing consensus on automotive quality systems.
GMP Certification in Tanzania, which stands for good manufacturing practices, is a term that's frequently used to refer to the management and control of pharmaceutical product development, testing, and overall quality. It creates a set of standards for the quality assurance process. Products are manufactured in compliance with industry standards, thanks to GMP approval.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
Define, select, and apply various techniques including supplier qualification, certification, evaluation, ratings, performance
improvement, and so on.
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This document discusses process validation, which establishes documented evidence that a process will consistently produce a product meeting predetermined specifications and quality attributes. It defines process validation according to various regulatory bodies and experts. The key aspects of process validation include conducting studies using larger sample sizes and more frequent testing of at least three successive batches to demonstrate the process is reproducible. Validation responsibilities, checklists, protocols, phases, reports, revalidation triggers, and focus areas during inspections are outlined.
This document outlines the agenda for a conference on obtaining FDA approval for AI-based medical devices. The agenda includes presentations on paving the path for FDA approval of AI devices, an open Q&A session with the FDA's Digital Health Center of Excellence, how to align product development with FDA regulations for AI, best pre-submission practices, and an update on the 510(k) program. There will also be breaks and a summary session. The presentations will provide guidance on navigating the FDA approval process for AI medical devices and obtaining feedback prior to formal submissions.
This document provides an overview of validation requirements in the pharmaceutical industry. It begins with definitions of validation from FDA guidelines in 1987 and 2011. Validation originated in the 1970s focused on sterilization, and has now expanded to all product, process, and facility matters. Validation is required to assure quality, is a regulatory requirement, and reduces costs. The stages of validation for a product and process are outlined, including process design, process qualification, and continuous process verification. Key aspects of validation like process validation, change control, and documentation are also summarized.
Join industry expert, Danny Kroo, key takeaways from the session include: 1. What is MDSAP and when should you consider it? 2. How to prepare for an MDSAP certification audit 3. What are common nonconformities issued by auditing organizations
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Quality & compliance excellence in pharmaceuticalsAnvita Bharati
Quality can be defined in several ways including conformance to specifications, fitness for use, and value for price paid. It is judged based on factors like performance, reliability, and support services provided. Pharmaceutical products have higher quality standards and more regulations compared to consumer goods due to their intended use and potential risks. Ensuring compliance with various quality guidelines is important for patient safety and involves establishing quality systems, policies, procedures, documentation, and ongoing assessments like audits and corrective actions. Non-compliance can result in issues like complaints, recalls, and regulatory actions.
Similar to FDA Update: Inspections, Observations and Metrics - OMTEC 2017 (20)
The Future of Digital Health and Wearables in OrthopedicsrablesApril Bright
Orthopedic device companies have responded to payors’ adoption of bundled payments and FDA’s promotion of digital health tools by commercializing products that track patients beyond the O.R. Digital health tools, including wearables, provide device companies with revenue streams that respond to hospitals’ episode of care requirements and patients’ personalized medicine needs, while simultaneously creating a feedback loop for product ideas. Christopher E. Pelt, M.D., a surgeon enrolled in Zimmer Biomet’s mymobility clinical study with the Apple Watch app, offered perspective on the benefits of wearables and shares ways that the technology will impact patients, surgeons and device companies in the future.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
Innovation in Orthopedics: Surgeon PerspectivesApril Bright
How can orthopedic manufacturers capitalize on the next wave of innovation? Which advancements will experience the greatest adoption in orthopedics, and why? The future of orthopedics is happening now. Progress is being made on materials that increase implant longevity, designs that improve patient outcomes and speed recovery, robotic and computer-assisted technologies that enhance accuracy, reliability and speed. This panel boasts future-minded surgeon entrepreneurs and researchers who have varied practical experience from the leading edge of tomorrow’s solutions. They shared perspective on what’s working in orthopedics, what gaps remain and how orthopedic manufacturers can develop new, relevant products that solve problems and alleviate pressures for surgeons and hospitals.
Antimicrobial Coatings: The Research and Regulatory PerspectiveApril Bright
Coatings have long been considered an avenue for infection prevention in orthopedic procedures. These coatings, some of which utilize silver, have largely not been commercialized because regulators seek greater evidence of their safety, creating a long, expensive road for device companies. Announcements in the last half of 2018 and early 2019 indicate that companies continue to push to get them on the market and that productive conversations are taking place with regulators. This session began with a history of antimicrobial coatings followed by a look at recent research and technology.
Leverage These Effective Communication Skills to Get Your Message AcrossApril Bright
Your success is highly dependent upon how well you communicate with your colleagues, your customers and your providers. Effective communication helps you reduce conflict and confusion while increasing motivation and productivity. No matter your age or title, communication is a timeless skill to practice and hone. Leveraging decades of training and managerial experience within device companies and his role as a professor, G. Bryan Cornwall provided the practical steps that you must take to become an excellent communicator.
Operations: Top Reasons for Long Lead Times and What to Do About ThemApril Bright
Long lead times remain one of the most vocalized challenges that orthopedic manufacturers face today. Customers, profits, plans and personnel are all negatively impacted by them. James Kwan has worked on the OEM and the supplier sides of orthopedics, and shared his ideas and successful experiences to help you optimally respond to lead times, reduce them and ultimately create and sustain an agile supply chain.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Joint Replacement: The Current and Future Impact of CoatingsApril Bright
The control of surface properties to reduce wear and corrosion and improve biocompatibility is of particular interest today as device companies—and surgeons, payors and patients—seek to extend the life of knee and hip implants. In this session, device companies shared research on their joint replacement coatings and materials, covering pros, cons and the future of their technology.
Engineers: Practical Application of Project Management PrinciplesApril Bright
Predictability throughout the commercialization chain is critical to allow manufacturers to speed products to market and gain share within the growing orthopedic industry. As an engineer, your technical and regulatory expertise will be overshadowed if you cannot properly plan and execute a project. One skill every engineer must learn and hone is project management. Start with the steps shared in this session.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray AreasApril Bright
The document discusses regulatory gray areas and provides examples of how experts navigate ambiguous requirements. It addresses topics like complaints, clinical evaluation reports, unique device identification, and validation sample sizes. For complaints, it provides case examples and discusses when to investigate and report. For clinical evaluation reports, it discusses author credentials and responding when not all indications have data. For unique device identification, it discusses applicability based on size. For validation, it discusses sample size requirements and working with suppliers. Finally, it discusses supplier relationships and appropriate handling of defects. The key takeaway is that communication, documentation, and asking for help can aid in navigating regulatory uncertainties.
The Future of Orthobiologics in Trauma ProceduresApril Bright
Based on his clinical research interests in utilization of Alpha-BSM bone graft substitute and OP-1 recombinant BMP in the repair of fractures, Daniel N. Segina, M.D., outlined opportunities and challenges for surgeons and device companies in biologic development. To make his case, Dr. Segina reviewed the spectrum of orthobiologics used in trauma cases today, shared perspective on what is and isn’t working and forecasted the future of regenerative medicine.
Spine Implants: Porous Coatings vs. Porous Materials vs. Additive ManufacturingApril Bright
Spine implant materials and surface characteristics are popular topics among engineers and surgeons. How do surface technologies relate to spine implants and bone integration and fusion? What are the pros and cons of various materials and surfaces? In this interactive session, members of industry and academia reviewed and presented research related to use of
• porous plasma spray coating,
• porous PEEK, and
• additive manufactured titanium in spinal devices.
How to Influence People: The Value of Employee EngagementApril Bright
Engagement is a powerful tool to drive accomplishment of individual and company objectives. Success requires a genuine interest in achieving the goals of the company as well as making connections between those goals and the personal motivations of your team. Employee engagement is lauded by many as the single most fulfilling aspect of their jobs.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
Orthopedic Coatings: Predictions for 2025April Bright
What are the next innovations in orthopedic coatings? What orthopedic market stands to benefit the most from coatings? What’s stalling coating innovation? This session brought together the device company and coating manufacturer perspective to discuss which coatings will be used in orthopedics in the next decade.
Engineers: Apply Automation to Increase Quality, Speed to MarketApril Bright
We live in the age of machine learning, artificial intelligence and other automated systems. Why, then, are we performing tedious tasks that we can streamline during the product development phase? First, there is Design Verification testing. Second, there is Design Validation testing. Some of these tests use simple pass/fail attribute data, while others use continuous data. We will focus on ways to automate the analysis of that continuous data, which can ensure more accurate and timely results.
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
Additive Manufacturing - Mechanical Test Methods - OMTEC 2018April Bright
Medical devices fabricated from additively-manufactured materials must undergo a variety of mechanical tests before receiving regulatory approval. Due to the complexity of manufacturing processes and the limited clinical knowledge of AM devices, they are subject to additional scrutiny by manufacturers and Notified Bodies. Several test methods for characterizing these devices are presented in this session, as well as the differences between testing additively-manufactured devices and those fabricated with traditional machining methods.
Analyze and Optimize Your Supply Chain Operations for Higher Performance - OM...April Bright
The operations science pioneered through Factory Physics provides practical concepts to analyze and optimize supply chain operations. This presentation covers basic approaches for operations science to enhance your world, with all its variability in product mix, demand, people and processes. You will get applications of the science to apply immediately.
Carrer goals.pptx and their importance in real lifeartemacademy2
Career goals serve as a roadmap for individuals, guiding them toward achieving long-term professional aspirations and personal fulfillment. Establishing clear career goals enables professionals to focus their efforts on developing specific skills, gaining relevant experience, and making strategic decisions that align with their desired career trajectory. By setting both short-term and long-term objectives, individuals can systematically track their progress, make necessary adjustments, and stay motivated. Short-term goals often include acquiring new qualifications, mastering particular competencies, or securing a specific role, while long-term goals might encompass reaching executive positions, becoming industry experts, or launching entrepreneurial ventures.
Moreover, having well-defined career goals fosters a sense of purpose and direction, enhancing job satisfaction and overall productivity. It encourages continuous learning and adaptation, as professionals remain attuned to industry trends and evolving job market demands. Career goals also facilitate better time management and resource allocation, as individuals prioritize tasks and opportunities that advance their professional growth. In addition, articulating career goals can aid in networking and mentorship, as it allows individuals to communicate their aspirations clearly to potential mentors, colleagues, and employers, thereby opening doors to valuable guidance and support. Ultimately, career goals are integral to personal and professional development, driving individuals toward sustained success and fulfillment in their chosen fields.
XP 2024 presentation: A New Look to Leadershipsamililja
Presentation slides from XP2024 conference, Bolzano IT. The slides describe a new view to leadership and combines it with anthro-complexity (aka cynefin).
This presentation by Yong Lim, Professor of Economic Law at Seoul National University School of Law, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
This presentation by Nathaniel Lane, Associate Professor in Economics at Oxford University, was made during the discussion “Pro-competitive Industrial Policy” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/pcip.
This presentation was uploaded with the author’s consent.
Collapsing Narratives: Exploring Non-Linearity • a micro report by Rosie WellsRosie Wells
Insight: In a landscape where traditional narrative structures are giving way to fragmented and non-linear forms of storytelling, there lies immense potential for creativity and exploration.
'Collapsing Narratives: Exploring Non-Linearity' is a micro report from Rosie Wells.
Rosie Wells is an Arts & Cultural Strategist uniquely positioned at the intersection of grassroots and mainstream storytelling.
Their work is focused on developing meaningful and lasting connections that can drive social change.
Please download this presentation to enjoy the hyperlinks!
This presentation by OECD, OECD Secretariat, was made during the discussion “Pro-competitive Industrial Policy” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/pcip.
This presentation was uploaded with the author’s consent.
This presentation by OECD, OECD Secretariat, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
This presentation by Juraj Čorba, Chair of OECD Working Party on Artificial Intelligence Governance (AIGO), was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
This presentation by Thibault Schrepel, Associate Professor of Law at Vrije Universiteit Amsterdam University, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
Mastering the Concepts Tested in the Databricks Certified Data Engineer Assoc...SkillCertProExams
• For a full set of 760+ questions. Go to
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Suzanne Lagerweij - Influence Without Power - Why Empathy is Your Best Friend...Suzanne Lagerweij
This is a workshop about communication and collaboration. We will experience how we can analyze the reasons for resistance to change (exercise 1) and practice how to improve our conversation style and be more in control and effective in the way we communicate (exercise 2).
This session will use Dave Gray’s Empathy Mapping, Argyris’ Ladder of Inference and The Four Rs from Agile Conversations (Squirrel and Fredrick).
Abstract:
Let’s talk about powerful conversations! We all know how to lead a constructive conversation, right? Then why is it so difficult to have those conversations with people at work, especially those in powerful positions that show resistance to change?
Learning to control and direct conversations takes understanding and practice.
We can combine our innate empathy with our analytical skills to gain a deeper understanding of complex situations at work. Join this session to learn how to prepare for difficult conversations and how to improve our agile conversations in order to be more influential without power. We will use Dave Gray’s Empathy Mapping, Argyris’ Ladder of Inference and The Four Rs from Agile Conversations (Squirrel and Fredrick).
In the session you will experience how preparing and reflecting on your conversation can help you be more influential at work. You will learn how to communicate more effectively with the people needed to achieve positive change. You will leave with a self-revised version of a difficult conversation and a practical model to use when you get back to work.
Come learn more on how to become a real influencer!
3. 2
Source: FDA’s Field Accomplishment and Compliance Tracking System (FACTS)
Key Finding CY2016
o Slight increase in overall number of
QS Surveillance Inspections in CY16
vs. CY15
o Increase in No Action Indicated (NAI)
inspection outcomes (both domestic
and foreign)
o Fewer 483s were issued
to firms in CY16
o All QS subsystems saw a drop in
the number of 483 observations
o Increase in Foreign Inspections and
decrease in Domestic Inspections
(consistent with the increase in
foreign firms actively registered
and listed)
o Number of WLs issued dropped
from 121 (CY15) to 57 (CY16)
4. 3
FDA Establishment Inspections
Form FDA-483 Inspectional Observations
• Issued at the conclusion of an inspection when an investigator
has observed any conditions that my constitute violations of
the Food Drug and Cosmetic (FD&C) Act and related Acts
• Used to document concerns discovered during FDA Inspections
• Multiple observations may be listed on the FDA-483 Form
• Note: FDA-483s do NOT cover every possible deviation from
law and regulation
5. 4
FDA Establishment Inspections
Inspection Outcomes / Classification
• Official Action Indicated (OAI)
– An OAI inspection classification occurs when significant objectionable conditions or
practices were found and regulatory action is warranted to address the
establishment's lack of compliance with statute(s) or regulation(s).
• Voluntary Action Indicated (VAI)
– A VAI inspection classification occurs when objectionable conditions or practices were
found that do not meet the threshold of regulatory significance. Inspections classified with
VAI violations are typically more technical violations of the FDCA.
• No Action Indicated (NAI)
– An NAI inspection classification occurs when no objectionable conditions or practices were found during the
inspection or the significance of the documented objectionable conditions found does not justify further actions.
• If no enforcement action is contemplated, or after enforcement action is concluded, FDA provides
inspected establishments with a final inspection report, called an Establishment Inspection Report (EIR)
Source: www.fda.gov
6. 5
Top 10 Foreign Inspection Location (CY15 – CY16)
Country Name CY 2015 # of
Inspections
Country Name CY 2016 # of
Inspections
China 126 China 179
Germany 90 Germany 71
Japan 44 Japan 60
Canada 42 United Kingdom 50
United Kingdom 35 Taiwan 35
Taiwan 35 France 29
France 30 Switzerland 29
Italy 26 Italy 27
S. Korea 22 Canada 26
Ireland 19 Ireland 25
Source: FDA
7. 6
QS Medical Device Inspections Outcomes, FY 2016
Domestic Inspection Outcomes % Foreign Inspection Outcomes %
NAI 779 54% NAI 351 48%
VAI 567 39% VAI 288 40%
OAI 104 7% OAI 86 12%
Total 1,450 725
Source: FDA
12. 11
Most Frequently Cited 483 Observations (FY06 – FY16)
1) Procedures for Corrective and Preventive Action have not been
[adequately] established. Specifically, ***
2) Procedures for receiving, reviewing, and evaluating Complaints by a formally
designated unit have not been [adequately] established. Specifically,***
3) Written MDR procedures have not been [developed]
[maintained] [implemented]. Specifically, ***
4) Corrective and Preventive Action activities and/or results
have not been [adequately] documented. Specifically, ***
5) A Process whose results cannot be fully verified by subsequent inspection and
test has not been [adequately] Validated according to established procedures.
Specifically, ***
Source: FY06-16 Inspectional Observations
15. 14
FDA Case for Quality
• Launched in 2011 and is part of CDRH’s 2016-2017 Strategic Priority to
promote a culture of quality and organizational excellence.
– Core Components
• Focus on Quality
• Enhanced Data Transparency
• Stakeholder Engagement
• MDIC has sponsored four Case for Quality Working Groups since 2014
– Maturity Model
• Enable an organization to assess the capability of its quality system
to reliably develop and manufacture high quality medical devices.
– Metrics
• Create well-defined, stakeholder-verified (FDA and industry)
product quality metrics to predictively assess product quality.
– Advanced analytics
• Offer hospital providers information and analysis techniques to evaluate
medical device quality and subsequent patient value.
– Competencies
• Construct techniques that improve competency across systems and individual functions.
www.fda.gov www.mdic.org
16. 15
FDA – On the Horizon: Case for Quality
What is this Case for Quality Initiative?
• …shift historical focus from compliance & enforcement action to device quality
• ...launched after device quality data demonstrated lack of improvement in
risk to patient safety & the number of enforcement actions taken by
FDA year after year
• ...goal is to proactively and predictively measure risk to product quality
• ...Right The First Time mentality shifting as close to initial days of development
as possible
• ...manageable system of metrics across the Total Product Lifecycle
• ...ultimate goal is continual improvement with root cause of failure taken
back to earliest stages of development as possible
Source: MDIC Quality Metrics Best Practices
17. 16
Where is the FDA Case for Quality Going?
Source: www.fda.gov MDIC CfQ Metrics Workshop
18. 17
What Does This Mean?
FDA Regulatory Paradigm Shift
• What does a focus on quality and organizational
excellence mean for FDA and innovation?
– Increased manufacturing and product confidence
– Faster time to markets, better information to drive
regulatory decisions, improved resource allocation
– A focus on what is most important to patients
Remove participants from the agency work plan for routine inspections
Waive pre-approval inspections where appropriate
Engagement and meetings on issue resolution
Modifying submission requirements and faster FDA response
Accelerated approval path
Competitive market around product excellence
Source: www.fda.gov
19. 18
Maturity Model Workstream - Goal Statement
Develop a program which leverages CMMI (Capability Maturity Model Integration) as the
standard maturity model by which medical device organizations may measure their
capability to produce high quality devices. FDA will adjust their engagement activities and
submission requirements as a recognition of this independent assessment of quality
maturity.
Source: MDIC CfQ
22. 21
Pilot Study Metrics
Total # of changes (product & process across projects)
total # of projects
Total # of changes (product & process for each project)and/or
# of units mfg. Right First Time within or across lots
# of units started
Post-Production Metric
Production Revised Metric
Pre-Production Revised Metric
Aggregation of weighted (risk based) post market metrics: Service Records,
Installation Failures, Complaints, MDR’s, Recalls Rates, Recalls Total….
23. 22
MDIC “Best Practices”
• Metric output can be used to understand root causes
• Combine metric output with other metrics to understand
a more holistic picture and analyze trends
• Goal is to provide a feedback loop to improve systems from the
earliest point possible that allowed the failure to occur originally
Purpose: To help organizations understand how best to
use the output from the metrics to inform
decisions and trigger actions
24. 23
Total Product Lifecycle
• This process [approach] can be used to identify ways to
measure previously untracked areas of quality and/or risk
• Assess which critical requirements the metric is correlated to,
in order to be sure it has the potential to be effective
• Be sure to assess the usefulness of the metric over time
– Is it a flat-line result over time?
– Are any decisions or actions ever taken as a result of tracking?
– Has the metric demonstrated acceptable improvement and steady-state?
– Is unacceptable quality and/or risk experienced even though
this metric is consistently acceptable?
Source: MDIC Case for Quality, Metrics
25. 24
Pre-Production: Design Robustness
• Goal of the Pre-Production Metric: to drive the Right-First-Time (RTF) mindset in the
research and development phase such that post-design transfer changes due to
inadequate product/process development are not needed.
Only include changes required due to inadequate product or process development (harmonize definition across organization)
26. 25
ECO
ECR
Manufacturing FieldDesign
Change
E
C
R
Mfg or
Design
Cost of:
• Verification
• Validation
• Process Validation
• Ext. Certification
• Registration/Clearance
• Cost/FA
• Cost/CAPA
• Cost/Design Change
Impacted by changes
• IEC (Elec. Safety…)
• Toxicology/Bio-compatibility
• Environmental (WEEE, RoHS…)
• Declaration of Conformity
• Supplier Qualification
• Cleaning/Sterilization
• Risk Management
• Labeling
• Training
• Disposition (Inventory, Scrap, Rework…)
Summing Junction for Post-RfDT
product and process changes due to
inadequate product/process
development
Change
C
R
Pre-Production / Design Robustness
Data Sources
• NCRs
• SCARs
• Deviations
• Improvement Projects
Data Sources
• Complaints
• Adverse Events (MDR, MDV...)
• Recalls / Field Actions
• Installation Reports
• Service Events
• Product Returns
MDIC Pre-Production Metric
Design Xfr
Release for Design Transfer (RfDT)
Design Phases/Processes
• Requirements
• Specifications
• Verification
• Validation
• Process Validation
• Clinical Trials
• Prototyping
• Usability
• Bio-compatibility
• Risk Management
• Design Review
• Lifecycle testing
• Compliance (i.e. to standards)
• Labeling
Manufacturing Processes
• Inspection
• Process Validation
• Inventory Control
• Environmental Control
• Process Capability
• Control / Reaction Plans
• FMEA
• Preventive Maintenance
• Calibration
Y
N
Design
Mfg
Y
N
Total # of changes (product & process across projects)
total # of projects
and/or
Total # of changes (product & process for each project)
Note: Each organization must determine what constitutes a project
28. 27
How well do you really know your systems?
• Can you metrics be interpreted accurately?
• What questions should you be asking your organization
in regards to data?
• Are you, your suppliers and your customers all singing
from the same hymnal?
Decide what data you need
How will this data be used?
• Capability?
• Defects?
• Yield?
• etc.
Data Collection / Metrics / Dashboards
Develop data collection plan
• What will we measure?
• How will we measure it?
• Where will we measure it?
• How often will we measure it?
Ensure data integrity (MSA)
• Accurate
• Precise
• Repeatable
• Reproducible
Determine how data will be presented
Determine Reaction to data
• Containment
• Correction
• Improvement
• Design Change
30. 29
Data Collection Concepts / Preparation
Do we know what defective means?
• Have we defined the acceptable
and unacceptable aspects of
the process?
• For example: If you were
asked to count the number of
defective M&Ms in a bag, we’d
get a wide range of answers.
Why?
31. 30
Data Collection Concepts / Preparation
Do we know what acceptable means?
• Not everyone sees the same things. What is
acceptable to some may be unacceptable to others.
That’s not a manufacturing defect,
It’s supposed to have a hole in the middle
32. 31
Data Collection Plan
Develop Data Collection Plan
• A well-prepared Data Collection Plan helps ensure
successful analysis of the problem. Data Collection Plans
should answer the following set of questions:
– What data will be collected (including data type)
– Attribute data — qualitative (Yes/No, Pass/Fail, Damage/No Damage)
– Variable data — quantitative (Time, Dimensions, Percentage)
– Why the data is needed
– Where data will be collected
– How the data will be collected
– Who will collect the data
Key Concept
Collecting an appropriate amount of the
right data.
Too much data can add complexity to the
data review and analysis. Too little data may
force the team to engage in a secondary data
collection effort. Likewise, correctly
specifying what data is to be collected
(enough to get a complete picture of the
process) will help the team avoid
unnecessarily repeating initial collection
activities.
33. 32
Can you trust your data?
• What does this mean?
• Stability
• Accurate (Bias)
• Linearity
• Repeatability
• Reproducibility
• Are we measuring the “right” thing?
– For example, does our data match with what our
customers are saying?
– Liftgate Example
34. 33
Measurement System Analysis (MSA)
• The purpose of performing a Measurement
System Analysis is to ensure the information
collected is a true representation of what is
occurring in the process.
• It is important to remember that Total Variation
is the sum of Process Variation and
Measurement System Variation. Therefore,
minimizing measurement variation ensures
that only process variation is reflected
by the data.
At the conclusion of the Measurement System
Analysis, you should know:
• Whether the measurement system is “capable” of gathering
data that accurately reflect variation in the process
• Whether there is measurement error, how big it
is and a method of accounting for it
• What confidence level can be attached
to the measurements collected
• Whether or not measurement increments
are small enough to show variation
• Sources of measurement error
• Whether the measurement system will be stable over time
Measurement System:
The thing being measured +
the device(s) used to take the
measurement + the person
doing the measuring
35. 34
Components of Measurement System Error
• Resolution/Discrimination
• Accuracy (bias effects)
• Linearity
• Stability (consistency)
• Repeatability-test-retest (Precision)
• Reproducibility (Precision)
Each component of measurement error contributes to variation,
causing wrong decisions to be made.
36. 35
We did the MSA; so what?
• Stable: Capacity of measurement system to obtain
the same result when measuring the same part
over a significant period of time. (Stability implies
only common cause variations.)
• Accurate (Bias): The closeness of a measured
value to a standard or known value
• Linear: A measure of bias over the range
of the measurement device.
• Repeatable: Can the same person
measure the same part multiple
times with the same measurement
device and get the same value?
• Reproducible: Can different people
measure the same part with the same
measurement device and get the
same value?
The analysis answers the questions, is the Measurement System:
Measurement system
corrections resulting from
MSA lead to precise and
accurate data
37. 36
We did the MSA, so what?
The analysis answers the questions; is the Measurement
System:
• What is the measurement error?
• What do I do with this measurement error?
• Capable of measuring the process?
• If I improve my process, will the measurement system still be
ok?
– The output of an MSA provides indices that represent the
measurement systems ability to measure within the process spread
and also within the tolerance band. If process improvements are
made or the tolerance limits are tightened beyond the
measurement system capability, the changes to the measurement
system are necessary.
• Will the MSA ever need to be repeated?
38. 37
Let’s Start Measuring…oh wait...
What about a sampling plan?
Sampling Approaches:
Random Systematic
Sampling Sampling
Each unit has the Sample every nth
same chance of one (ie: every 3rd)
being selected.
Stratified Subgroup
Random Sampling
Sampling
Randomly sample Sample n units
a proportionate every nth time
number from (ie: 3 units every
each group. Hour); then
calculate the mean
(proportion) for
each subgroup.
SamplePopulation
SamplePopulation
AABBBBCDDD
A
A
A
A
B
B B
B
BBB
C
C
D D D
D D D
B
Sample
Population
or Process
Preserve time order
Sample
Population
or Process
Preserve time order
SampleProcess
9:00 9:30 10:3010:00
Preserve time order
SampleProcess
9:00 9:30 10:3010:00
Preserve time order
Sampling Considerations
• Where
o Location in the process where process steps directly
affect outputs (strong relationship).
o Maximize opportunity for problem
identification (cause data).
• Frequency
o Dependent on volume of transactions and/or
activity
o Unstable process – more frequent sampling
o Stable process – less frequent sampling
o Dependent on how precise the measurement must
be to make a meaningful business decision
• Considerations
o Is the sample representative of the process or
population?
o Is the process stable?
o Is the sample random?
o Is there an equal probability of selecting any data
point?
39. 38
What’s the Point? (Take-aways)
Do we / Have we:
• Identified the appropriate data that we need to collect?
• Determined how to collect it?
• Determined where to collect it?
• Determined when to collect it?
• Determined the sampling plan?
• Studied the measurement system?
• Determined how to manage the data?
• Understand the sources of variation in our processes?
• Developed reaction plans?
• Know how to form a proper problem statement?
• Know how to effectively conduct an investigation?
• Understand interim and permanent corrective action?
• Verified root cause?
• Can we eliminate unnecessary measurements?