Podcasts about design control

The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution?  Naveen Agarwal from Exceed will answer this question. So don't miss this episode to know more about QMSR.  Who is Naveen Agarwal?  Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Naveen Agarwal Linkedin Profile: https://www.linkedin.com/in/naveenagarwal/  Learn more about Let's Talk Risk! here ans subscribe: https://naveenagarwalphd.substack.com/about  Webinar recording - Getting Ready for QMSR: https://naveenagarwalphd.substack.com/p/webinar-5-getting-ready-for-qmsr   Risk management training on ACHIEVE:  https://www.achievexl.com/    Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

When you look at ISO 13485 or EU MDR or US FDA, they all want to see that you are reducing the risk for your products. But to do that you have to brainstorm and identify those risks. Usually, we follow ISO 14971 for that. But not all of your team is aware of this, and we are now short on time. So, what to do? Draft it by yourself or work with some colleagues. Naveen Agarwal will be sharing with us the best way to collaborate to create a successful Risk Management process. So, let's listen to that.  Who is Naveen Agarwal?  Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Naveen Agarwal Linkedin : https://www.linkedin.com/in/naveenagarwal/ Linkedin Post: https://naveenagarwalphd.substack.com/p/collaboration-is-the-secret-sauce-for-riskmgmt  Achieve Website: https://www.achievexl.com  Let Us Talk Risk Newsletter: https://naveenagarwalphd.substack.com/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

Listen to this first episode as we prepare to explain the INNOVATION ROADMAP™: Device Innovation as a Result of Embracing Regulatory Controls: FDA-QSR & ISO-13485, with the CEO of MIDI Medical Product Development, Chris Montalbano. In this episode, Chris outlines how to take control of the medical device development process utilizing a DevelopmentDNA™ approach. He begins by explaining a common misperception in the industry that the Medical Regulatory Design Controls and Risk Management (under ISO-13485) are often viewed as a mandate, a process that will inhibit device innovation. The perception shift to be revealed will involve the utilization of FDA Guidance, Regulations as well as Design Control & Risk Management as a viable medical device development innovation platform given a properly outlined INNOVATION ROADMAP™. Under this approach, MIDI's team of engineers and usability experts tied to their industrial designers have the ability to utilize DevelopmentDNA™'s "INNOVATION ROADMAP™ to address the functional, cost-to-manufacturer, safety, and business requirements of what Chris calls 'the golden standard approach', which is paired with the follow-through to execute upon that approach in a rapid, AGILE product development fashion under MIDI's Quality-First™ umbrella.

George was invited to converse with Naveen Argarwal on a recent post he put up on Linkedin about seatbelts.  They talk CAPA, risk management, quality culture, and leadership (to name a few!)  Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.You can find him and information about his work, especially regarding risk management for medical devices here:   https://www.achievexl.com/https://www.linkedin.com/in/naveenagarwal/You can also watch this episode here:  https://www.youtube.com/watch?v=DERVviyppL0 

The evaluation of the Risk-Benefit ratio is key for Risk Management Files per ISO 14971 or when you build your Clinical Evaluation Report or when you need to define the risk of using a particular technology against another. I mean that risk-benefit evaluation is mainly what helps us to decide that our product is safe and performant. So on this episode, Naveen Agarwal from Achieve will be my guest and help us understand the best way to measure your benefit-risk ratio. Who is Naveen Agarwal? Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links: Naveen LinkedIn profile: https://www.linkedin.com/in/naveenagarwal Exceed consulting solution: www.exeedqm.com Achieve training: www.achievexl.com Case study https://www.achievexl.com/benefit-risk-analysis-fda-case-study Downloadable white paper from the FDA: https://www.fda.gov/medical-devices/products-and-medical-procedures/weight-loss-and-weight-management-devices

Podcast: RSA ConferenceEpisode: Critical Infrastructure at Risk: Uncovering the Danger of insecure-by-design Control System SoftwarePub date: 2023-01-17In this podcast, we will uncover the realities of insecure control systems software in critical infrastructure. From discovering zero-days to exposing vulnerabilities in built-in features, we'll explore the role of both vendors and operators in safeguarding our essential utilities. By the end, listeners will have a new perspective on the need to implement strong security practices into the foundation of the control systems that make modern life possible. Don't miss out on this crucial conversation about the current state and the future of our critical infrastructure! Speakers: Brian Foster, GMS Cybersecurity Lead, South California Edison Kacy Zurkus, Content Strategist, RSACThe podcast and artwork embedded on this page are from RSA Conference, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.

On this episode I was joined by David Rutledge, author of Mythical Medical and CEO of Global Strategic Solutions. David Discusses: · His book Mythical Medical · Benefit (As part of Benefit/Risk) · PRRC Role and EU MDR David R Rutledge, Pharm.D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk management, regulatory, and quality. He brings 25 years' global experience with agencies such as US FDA, Brazil ANVISA, Mexico COFEPRIS, NMPA (China FDA), S Korea Ministry of Food and Drug Safety, Hong Kong, Malaysia, Health Canada, Australia TGA, Thailand FDA, Japan PMDA, EMA, Saudi FDA, CDSCO of India and several Notified Bodies, e.g., BSI, DEKRA, Medcert, and TÜV SÜD. He previously accepted a 4-year appointment from the United States Department of Health & Human Services to serve as the Industry Representative on the FDA's General Hospital and Personal Use Devices Advisory Committee in FDA's Center for Devices and Radiological Health (CDRH). He is certified as a Lead Auditor for Quality Management Systems ISO13485 and holds certificates for Design Control, Risk Management, Six Sigma and CAPA. He qualified as an EU Person Responsible for Regulatory Compliance (PRRC)

In this podcast, we will uncover the realities of insecure control systems software in critical infrastructure. From discovering zero-days to exposing vulnerabilities in built-in features, we'll explore the role of both vendors and operators in safeguarding our essential utilities. By the end, listeners will have a new perspective on the need to implement strong security practices into the foundation of the control systems that make modern life possible. Don't miss out on this crucial conversation about the current state and the future of our critical infrastructure! Speakers: Brian Foster, GMS Cybersecurity Lead, South California Edison Kacy Zurkus, Content Strategist, RSAC

On this episode I was joined by Chris Tsai from Boothroyd Dewhurst, Inc. Chris and I discuss: Value Engineering at Eastman Kodak in the 1990's Inventing and Deploying Concurrent Engineering Defining Design Robustness QFD and Design Control in Non-Regulated Industries Verb/Noun Pairs and Product Development Design for Manufacturability and Assembly Chris Tsai is the Director of Implementation at Boothroyd Dewhurst Inc. Chris is a Lean Six Sigma and Value Analysis/Value Engineering professional with a thirst for harvesting productivity and quality improvements and a passion for professional growth. He's worked in a diverse set of new product development (NPD) and manufacturing operations management experience. He's been recognized for his decisive, consistent leadership style, strong team building skills, focus on personnel & organization development, and the persistent and effective application of productivity and quality improvement tools.

In this episode of RCA Radio, host Brandon Miller is joined by Jessica Schafersman, Biomedical Engineer, Project Management Professional, and Certified Usability Analyst at Regulatory Compliance Associates® (RCA) to talk about Design controls and the proper way to go about developing your DHF for your Medical Device products.Jessica has over 20 years of experience in medical product development. She started her career in a medical device startup, working directly with physicians and end users to develop a bleeding edge surgery system. Since then, her work experience has spanned combination products, sterile implants, sterile disposables, capital equipment, and instrumentation at all phases of development. She is currently one of RCA's Quality subject matter experts in helping clients create and improve their design history files as well as the entire Quality Management System.Listen in as Jessica goes over the trends we as consultants are seeing, how experts can help in the process, the first steps in getting the right help, and finish off with some major pitfalls clients face during the DHF process.About RCARegulatory Compliance Associates®  (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceLab TestingWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

This week, Alan Golden hosts a comprehensive discussion on the changes driven by risk and conversely risk updates that are driven by change as well as risk integration. Alan will share his expertise from over 30 years in the medical device industry. Alan Golden: Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management, and process/test method validation. Alan has more than 30 years of experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.    This episode is brought to you by IVT Network's Validation Week.

We are reminded here that our reliable reference is R. Buckminster Fuller's Synergetics Explorations in the Geometry of Thinking. Primarily because it is a wellspring of knowledge filled with geometric models and illustrations to which a conceptuality can mindfully refer when clarifying thought-language in a world that by comparison to other times can seem almost impossible to fathom.  Fathoming variously perceived realities has always been a challenge for intellect's observations of the articulations.  That they are always reenacting articulations of the residual inaccuracies of observation and articulation is a conceptual reminder from Bucky whose understanding of the world always included mathematics and geometry and a profoundly intelligent use of language.  Such thinking appeals to intuitive curiosity concerning accurate measurement not precisely as it would be required for the lifesaving difference as structures are engineered to withstand stresses to the extreme degree.  The measurement herein is mostly concerned with being informed of geometry and topology that can be used to measure and coordinate all information regarding experiences and which historically omitted these correlations relative to the physical quantitative experiences and the conceptually metaphysical experiences. (Synergetics 200.06)It is more enlightening to learn it is the human mind that discovers the eternal interrelationships, whereas the human brain seems mostly interested in beginnings and endings.  Perhaps this means the human mind deals with the eternal and brain deals with interpretations of what is conveyed to have begun at some time and will terminate at some other time.  The range of innovations between starting and finishing, beginning and ending is limitless.  It is to what an imagination subjects its emulative penchant to accredit the source of information  based on perceptions and deceptions. Read Transcript, relevant links included and Song Lyrics

This week, Stacey is joined by Roberta Goode, who will moderate a discussion on Combination Product Development and some of the challenges that arise in the process. Stacey and Roberta are joined by panelists Becky Leibowitz from Janssen, Kurt Moyer from Pine Lake Laboratories, and Alan Golden from Design Quality Consultants.   Resource from this episode: EU Medical Device General Safety and Performance Guidance – MDR ANNEX 1 Guidance FDA 21 CFR Part 4 – Subpart A – Current GMP for Combo Products FDA 21 CFR Part 4 – Subpart B Post-marketing Safety Reporting for Combo Products ICH Q9 QRM Guidance ISO 10993 – 2018 ISO 11607 Sterile Barrier ABOUT OUR GUESTS: ROBERTA GOODE - Moderator Roberta Goode is an executive with over 25 years of experience in the medical device industry. She is currently President and CEO of Goode Compliance International, a global leader in engineering and compliance services for medical device manufacturers, specializing in process validation, design control and risk management. Prior to founding GCI's medical device division in 1993, Ms. Goode held positions of increasing responsibility in R&D, Manufacturing and Quality Engineering at Beckman-Coulter Corporation, Althin Medical, Inc. (acquired by Baxter Healthcare), and Cordis Corporation (a Johnson and Johnson company), where she contributed intellectual property in the form of four US patents for percutaneous cardiovascular interventional devices. She holds a Master of Science degree in Biomedical Engineering and a Bachelor of Science degree from the University of Miami. Additionally, Ms. Goode has an adjunct faculty appointment at the University of Miami's College of Engineering and is an ASQ Certified Quality Engineer. ALAN GOLDEN – Panelist Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management and process/test method validation. Alan has more than 30 years' experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018. He can be reached at alangolden.dqc@gmail.com  BECKY LEIBOWITZ - Panelist Becky Leibowitz is Director of CMC Regulatory Affairs at Janssen and leads a team of regulatory professionals responsible for developing innovative CMC regulatory strategies for global drug-device combination product clinical trial and marketing applications.  At Janssen, Becky has been responsible for the device-specific sections of US and ROW regulatory submissions for single entity and co-packaged combination products, for new products in development and for post-approval changes.  Prior to Janssen, Becky developed biologic-device combination products and medical devices at ETHICON.  Becky holds both a BS and PhD in Mechanical Engineering. KURT L. MOYER – Panelist Kurt L. Moyer, Ph.D. is currently the President of Pine Lake Laboratories and was the General Manager of Pine Lake Laboratories predecessor NSF Health Sciences for over 10 years. Prior to joining NSF Health Sciences, Dr. Moyer served as a Senior Research Investigator for Sanofi Aventis and a Research Scientist for the DuPont Pharmaceutical Company. Dr. Moyer holds a Ph.D. in Biochemistry from Villanova University and a BS in Biochemistry from Millersville State University. He may be contacted at kmoyer@pinelakelabs.com or at 860-940-6550. He can be reached at kmoyer@pinelakelabs.com   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

The “smart” city of today looks little like what experts of yesteryear expected them to. In this book, Aaron Shapiro, Ph.D. takes readers on a behind the scenes tour of the smart city and shows the revolution in urban technology that is currently taking place in large metropolitan areas around the United States. Technology has fundamentally transformed urban life. Throughout Design, Control, Predict: Logistical Governance in the Smart City (U Minnesota Press, 2020), Shapiro develops a new lens called logistical governance in his effort to interpret and understand urban technologies. This lens was used to critique urban future based on extraction and rationalization. Through ethnographic research, journalistic interviews, and his own hands-on experience, Shapiro helps readers peer through cracks of the façade that smart cities are bearing. He investigates the true price New Yorkers pay for “free,” ad-funded WiFi, finding that it is ultimately serving the ends of commercial media. Shapiro also builds on his experience as a bike courier delivering food for a startup company and examines how promises of “flexible employment” in the gig economy paves the way for strict managerial control. And he turns his discussion toward the current debates about police violence and new patrol technologies, asking whether algorithms are the answer to reforming the ongoing crises of criminal justice in large urban cities. Through these gripping accounts of new technology in urban areas, Shapiro and Design, Control, Predict make vital contributions to conversations about data privacy and algorithmic governance. Shapiro provides a ground level account of a timely and important piece of research in Design, Control, Predict. This piece can be used when comprehending urbanism today and when identifying strategies to advance the critique and resistance to a dystopian future that is often viewed as inevitable. Michael O. Johnston, Ph.D. is an Assistant Professor of Sociology at William Penn University. His most recent research, “The Queen and Her Royal Court: A Content Analysis of Doing Gender at a Tulip Queen Pageant“, was published in Gender Issues Journal. He researches culture, social identity, and collective representation as it is presented in everyday social interactions. He is currently studying the social interactions that people engage in at two annual festivals that take place during the summer months along the banks of the Mississippi River. You can learn more about him on his website, Google Scholar, follow him on Twitter @ProfessorJohnst, or email him at johnstonmo@wmpenn.edu. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/public-policy

The “smart” city of today looks little like what experts of yesteryear expected them to. In this book, Aaron Shapiro, Ph.D. takes readers on a behind the scenes tour of the smart city and shows the revolution in urban technology that is currently taking place in large metropolitan areas around the United States. Technology has fundamentally transformed urban life. Throughout Design, Control, Predict: Logistical Governance in the Smart City (U Minnesota Press, 2020), Shapiro develops a new lens called logistical governance in his effort to interpret and understand urban technologies. This lens was used to critique urban future based on extraction and rationalization. Through ethnographic research, journalistic interviews, and his own hands-on experience, Shapiro helps readers peer through cracks of the façade that smart cities are bearing. He investigates the true price New Yorkers pay for “free,” ad-funded WiFi, finding that it is ultimately serving the ends of commercial media. Shapiro also builds on his experience as a bike courier delivering food for a startup company and examines how promises of “flexible employment” in the gig economy paves the way for strict managerial control. And he turns his discussion toward the current debates about police violence and new patrol technologies, asking whether algorithms are the answer to reforming the ongoing crises of criminal justice in large urban cities. Through these gripping accounts of new technology in urban areas, Shapiro and Design, Control, Predict make vital contributions to conversations about data privacy and algorithmic governance. Shapiro provides a ground level account of a timely and important piece of research in Design, Control, Predict. This piece can be used when comprehending urbanism today and when identifying strategies to advance the critique and resistance to a dystopian future that is often viewed as inevitable. Michael O. Johnston, Ph.D. is an Assistant Professor of Sociology at William Penn University. His most recent research, “The Queen and Her Royal Court: A Content Analysis of Doing Gender at a Tulip Queen Pageant“, was published in Gender Issues Journal. He researches culture, social identity, and collective representation as it is presented in everyday social interactions. He is currently studying the social interactions that people engage in at two annual festivals that take place during the summer months along the banks of the Mississippi River. You can learn more about him on his website, Google Scholar, follow him on Twitter @ProfessorJohnst, or email him at johnstonmo@wmpenn.edu. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/science-technology-and-society

The “smart” city of today looks little like what experts of yesteryear expected them to. In this book, Aaron Shapiro, Ph.D. takes readers on a behind the scenes tour of the smart city and shows the revolution in urban technology that is currently taking place in large metropolitan areas around the United States. Technology has fundamentally transformed urban life. Throughout Design, Control, Predict: Logistical Governance in the Smart City (U Minnesota Press, 2020), Shapiro develops a new lens called logistical governance in his effort to interpret and understand urban technologies. This lens was used to critique urban future based on extraction and rationalization. Through ethnographic research, journalistic interviews, and his own hands-on experience, Shapiro helps readers peer through cracks of the façade that smart cities are bearing. He investigates the true price New Yorkers pay for “free,” ad-funded WiFi, finding that it is ultimately serving the ends of commercial media. Shapiro also builds on his experience as a bike courier delivering food for a startup company and examines how promises of “flexible employment” in the gig economy paves the way for strict managerial control. And he turns his discussion toward the current debates about police violence and new patrol technologies, asking whether algorithms are the answer to reforming the ongoing crises of criminal justice in large urban cities. Through these gripping accounts of new technology in urban areas, Shapiro and Design, Control, Predict make vital contributions to conversations about data privacy and algorithmic governance. Shapiro provides a ground level account of a timely and important piece of research in Design, Control, Predict. This piece can be used when comprehending urbanism today and when identifying strategies to advance the critique and resistance to a dystopian future that is often viewed as inevitable. Michael O. Johnston, Ph.D. is an Assistant Professor of Sociology at William Penn University. His most recent research, “The Queen and Her Royal Court: A Content Analysis of Doing Gender at a Tulip Queen Pageant“, was published in Gender Issues Journal. He researches culture, social identity, and collective representation as it is presented in everyday social interactions. He is currently studying the social interactions that people engage in at two annual festivals that take place during the summer months along the banks of the Mississippi River. You can learn more about him on his website, Google Scholar, follow him on Twitter @ProfessorJohnst, or email him at johnstonmo@wmpenn.edu. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/new-books-network

The “smart” city of today looks little like what experts of yesteryear expected them to. In this book, Aaron Shapiro, Ph.D. takes readers on a behind the scenes tour of the smart city and shows the revolution in urban technology that is currently taking place in large metropolitan areas around the United States. Technology has fundamentally transformed urban life. Throughout Design, Control, Predict: Logistical Governance in the Smart City (U Minnesota Press, 2020), Shapiro develops a new lens called logistical governance in his effort to interpret and understand urban technologies. This lens was used to critique urban future based on extraction and rationalization. Through ethnographic research, journalistic interviews, and his own hands-on experience, Shapiro helps readers peer through cracks of the façade that smart cities are bearing. He investigates the true price New Yorkers pay for “free,” ad-funded WiFi, finding that it is ultimately serving the ends of commercial media. Shapiro also builds on his experience as a bike courier delivering food for a startup company and examines how promises of “flexible employment” in the gig economy paves the way for strict managerial control. And he turns his discussion toward the current debates about police violence and new patrol technologies, asking whether algorithms are the answer to reforming the ongoing crises of criminal justice in large urban cities. Through these gripping accounts of new technology in urban areas, Shapiro and Design, Control, Predict make vital contributions to conversations about data privacy and algorithmic governance. Shapiro provides a ground level account of a timely and important piece of research in Design, Control, Predict. This piece can be used when comprehending urbanism today and when identifying strategies to advance the critique and resistance to a dystopian future that is often viewed as inevitable. Michael O. Johnston, Ph.D. is an Assistant Professor of Sociology at William Penn University. His most recent research, “The Queen and Her Royal Court: A Content Analysis of Doing Gender at a Tulip Queen Pageant“, was published in Gender Issues Journal. He researches culture, social identity, and collective representation as it is presented in everyday social interactions. He is currently studying the social interactions that people engage in at two annual festivals that take place during the summer months along the banks of the Mississippi River. You can learn more about him on his website, Google Scholar, follow him on Twitter @ProfessorJohnst, or email him at johnstonmo@wmpenn.edu. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/sociology

The “smart” city of today looks little like what experts of yesteryear expected them to. In this book, Aaron Shapiro, Ph.D. takes readers on a behind the scenes tour of the smart city and shows the revolution in urban technology that is currently taking place in large metropolitan areas around the United States. Technology has fundamentally transformed urban life. Throughout Design, Control, Predict: Logistical Governance in the Smart City (U Minnesota Press, 2020), Shapiro develops a new lens called logistical governance in his effort to interpret and understand urban technologies. This lens was used to critique urban future based on extraction and rationalization. Through ethnographic research, journalistic interviews, and his own hands-on experience, Shapiro helps readers peer through cracks of the façade that smart cities are bearing. He investigates the true price New Yorkers pay for “free,” ad-funded WiFi, finding that it is ultimately serving the ends of commercial media. Shapiro also builds on his experience as a bike courier delivering food for a startup company and examines how promises of “flexible employment” in the gig economy paves the way for strict managerial control. And he turns his discussion toward the current debates about police violence and new patrol technologies, asking whether algorithms are the answer to reforming the ongoing crises of criminal justice in large urban cities. Through these gripping accounts of new technology in urban areas, Shapiro and Design, Control, Predict make vital contributions to conversations about data privacy and algorithmic governance. Shapiro provides a ground level account of a timely and important piece of research in Design, Control, Predict. This piece can be used when comprehending urbanism today and when identifying strategies to advance the critique and resistance to a dystopian future that is often viewed as inevitable. Michael O. Johnston, Ph.D. is an Assistant Professor of Sociology at William Penn University. His most recent research, “The Queen and Her Royal Court: A Content Analysis of Doing Gender at a Tulip Queen Pageant“, was published in Gender Issues Journal. He researches culture, social identity, and collective representation as it is presented in everyday social interactions. He is currently studying the social interactions that people engage in at two annual festivals that take place during the summer months along the banks of the Mississippi River. You can learn more about him on his website, Google Scholar, follow him on Twitter @ProfessorJohnst, or email him at johnstonmo@wmpenn.edu. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/architecture

The “smart” city of today looks little like what experts of yesteryear expected them to. In this book, Aaron Shapiro, Ph.D. takes readers on a behind the scenes tour of the smart city and shows the revolution in urban technology that is currently taking place in large metropolitan areas around the United States. Technology has fundamentally transformed urban life. Throughout Design, Control, Predict: Logistical Governance in the Smart City (U Minnesota Press, 2020), Shapiro develops a new lens called logistical governance in his effort to interpret and understand urban technologies. This lens was used to critique urban future based on extraction and rationalization. Through ethnographic research, journalistic interviews, and his own hands-on experience, Shapiro helps readers peer through cracks of the façade that smart cities are bearing. He investigates the true price New Yorkers pay for “free,” ad-funded WiFi, finding that it is ultimately serving the ends of commercial media. Shapiro also builds on his experience as a bike courier delivering food for a startup company and examines how promises of “flexible employment” in the gig economy paves the way for strict managerial control. And he turns his discussion toward the current debates about police violence and new patrol technologies, asking whether algorithms are the answer to reforming the ongoing crises of criminal justice in large urban cities. Through these gripping accounts of new technology in urban areas, Shapiro and Design, Control, Predict make vital contributions to conversations about data privacy and algorithmic governance. Shapiro provides a ground level account of a timely and important piece of research in Design, Control, Predict. This piece can be used when comprehending urbanism today and when identifying strategies to advance the critique and resistance to a dystopian future that is often viewed as inevitable. Michael O. Johnston, Ph.D. is an Assistant Professor of Sociology at William Penn University. His most recent research, “The Queen and Her Royal Court: A Content Analysis of Doing Gender at a Tulip Queen Pageant“, was published in Gender Issues Journal. He researches culture, social identity, and collective representation as it is presented in everyday social interactions. He is currently studying the social interactions that people engage in at two annual festivals that take place during the summer months along the banks of the Mississippi River. You can learn more about him on his website, Google Scholar, follow him on Twitter @ProfessorJohnst, or email him at johnstonmo@wmpenn.edu. Learn more about your ad choices. Visit megaphone.fm/adchoices

The “smart” city of today looks little like what experts of yesteryear expected them to. In this book, Aaron Shapiro, Ph.D. takes readers on a behind the scenes tour of the smart city and shows the revolution in urban technology that is currently taking place in large metropolitan areas around the United States. Technology has fundamentally transformed urban life. Throughout Design, Control, Predict: Logistical Governance in the Smart City (U Minnesota Press, 2020), Shapiro develops a new lens called logistical governance in his effort to interpret and understand urban technologies. This lens was used to critique urban future based on extraction and rationalization. Through ethnographic research, journalistic interviews, and his own hands-on experience, Shapiro helps readers peer through cracks of the façade that smart cities are bearing. He investigates the true price New Yorkers pay for “free,” ad-funded WiFi, finding that it is ultimately serving the ends of commercial media. Shapiro also builds on his experience as a bike courier delivering food for a startup company and examines how promises of “flexible employment” in the gig economy paves the way for strict managerial control. And he turns his discussion toward the current debates about police violence and new patrol technologies, asking whether algorithms are the answer to reforming the ongoing crises of criminal justice in large urban cities. Through these gripping accounts of new technology in urban areas, Shapiro and Design, Control, Predict make vital contributions to conversations about data privacy and algorithmic governance. Shapiro provides a ground level account of a timely and important piece of research in Design, Control, Predict. This piece can be used when comprehending urbanism today and when identifying strategies to advance the critique and resistance to a dystopian future that is often viewed as inevitable. Michael O. Johnston, Ph.D. is an Assistant Professor of Sociology at William Penn University. His most recent research, “The Queen and Her Royal Court: A Content Analysis of Doing Gender at a Tulip Queen Pageant“, was published in Gender Issues Journal. He researches culture, social identity, and collective representation as it is presented in everyday social interactions. He is currently studying the social interactions that people engage in at two annual festivals that take place during the summer months along the banks of the Mississippi River. You can learn more about him on his website, Google Scholar, follow him on Twitter @ProfessorJohnst, or email him at johnstonmo@wmpenn.edu. Learn more about your ad choices. Visit megaphone.fm/adchoices

The “smart” city of today looks little like what experts of yesteryear expected them to. In this book, Aaron Shapiro, Ph.D. takes readers on a behind the scenes tour of the smart city and shows the revolution in urban technology that is currently taking place in large metropolitan areas around the United States. Technology has fundamentally transformed urban life. Throughout Design, Control, Predict: Logistical Governance in the Smart City (U Minnesota Press, 2020), Shapiro develops a new lens called logistical governance in his effort to interpret and understand urban technologies. This lens was used to critique urban future based on extraction and rationalization. Through ethnographic research, journalistic interviews, and his own hands-on experience, Shapiro helps readers peer through cracks of the façade that smart cities are bearing. He investigates the true price New Yorkers pay for “free,” ad-funded WiFi, finding that it is ultimately serving the ends of commercial media. Shapiro also builds on his experience as a bike courier delivering food for a startup company and examines how promises of “flexible employment” in the gig economy paves the way for strict managerial control. And he turns his discussion toward the current debates about police violence and new patrol technologies, asking whether algorithms are the answer to reforming the ongoing crises of criminal justice in large urban cities. Through these gripping accounts of new technology in urban areas, Shapiro and Design, Control, Predict make vital contributions to conversations about data privacy and algorithmic governance. Shapiro provides a ground level account of a timely and important piece of research in Design, Control, Predict. This piece can be used when comprehending urbanism today and when identifying strategies to advance the critique and resistance to a dystopian future that is often viewed as inevitable. Michael O. Johnston, Ph.D. is an Assistant Professor of Sociology at William Penn University. His most recent research, “The Queen and Her Royal Court: A Content Analysis of Doing Gender at a Tulip Queen Pageant“, was published in Gender Issues Journal. He researches culture, social identity, and collective representation as it is presented in everyday social interactions. He is currently studying the social interactions that people engage in at two annual festivals that take place during the summer months along the banks of the Mississippi River. You can learn more about him on his website, Google Scholar, follow him on Twitter @ProfessorJohnst, or email him at johnstonmo@wmpenn.edu. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/technology

As the 50th anniversary of Apollo 11 loomed, interest in NASA history became a national pastime. Stories of where one (or one's parents) was, how it felt, and memorabilia collected at the time were pretty much guaranteed to keep a party conversation going. All would be well until someone would turn to the NASA website to try to find a small fact that couldn't quite be recalled. That's when the embarrassing pause in conversation would start because the NASA History website did not function in a way that supported modern users. As our metrics showed the climb of users with a decreasing bounce time, it was obvious that the long-debated overhaul could not wait. With the blessing of my wonderful boss, the support and talent of my visual designer, and the patience of teenagers, the overhaul rolled out publicly just in time for Anniversary. Much was learned along the way and makes for an excellent case study in finding resources, capitalizing on hidden talents, and why Pop-Tarts are still important in web development. Access the captioned version of this webcast at https://youtu.be/e8YKqP9R_S4

This week, Stacey is joined once again by Alan Golden. On this episode Stacey and Alan talk about ways in which medical device companies can prepare for audits, know what to expect during the audit, and how they should respond to audit findings.Alan Golden, MS, Principal Design Quality Consultants, LLC Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management and process/test method validation. Alan has more than 30 years’ experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018.Links: CFR 21 - Part 806.10. - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=806.10 CFR 21 – Part 806.20 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=806.20 ISO 13485:2016 - Medical device - QMS- Requirements for regulatory purposes - https://www.iso.org/standard/59752.html Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Margaret shares her rich history as an engineer in the automotive and medical device industries, including best practices for root cause failure analyses, what it’s like to be a woman in the male-dominated engineering industry, and how she helped “Weird Al” Yankovic get over stage fright early in his career. Pipeline Design & Engineering partners with medical device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, or automation equipment but don’t have the bandwidth or resources internally to develop that equipment. You can find us on the web at www.testfixturedesign.com and www.designtheproduct.com . Mechanical Engineering, Design Control, FDA, Regulatory, Automotive Engineering, Quality Control, Engineering Consulting, Design Validation Testing

Stacey Bruzzese welcomes back Alan Golden from Design Quality Consultants. Stacey and Alan have a conversation about combination products and what you need to be aware of.A review of the types of combo products, single-entity, co-packaged, and cross-labeled, as well as the FDA Guidance.The FDA’s 9 classifications for combo products – download the tableNavigating a multi-approval process and successful development processes and timingAligning the clinical trial and design validation phases in order to be efficient.Quality requirements under GMP and 21 CFR Part 4 including design controls for combination products to ensure that the product fulfils the requirements which were defined at the beginning of the project so that the final product fulfils the purpose.Design controls, a design and development plan, development activities and defining responsibility for implementation.Mitigating risk throughout the lifecycle of the productProcess for reporting adverse events for combination productsAlan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.Voices in Validation, Stacey Bruzzese, IVT Network, pharmaceutical, biotech, laboratories, medical devices, patient safety, quality control, United Podcast Network, Studio 21 Podcast Café, Alan Golden, Design Quality Consultants, change control, combination products,

In this modern digital world, did you know that most medical devices are not connected to the Internet? This episode of the Global Medical Device Podcast is a special live recording from The Greenlight Guru True Quality Roadshow in San Jose, California and is moderated by Tom Rish, Medical Device Guru at Greenlight Guru. Chris DuPont, CEO of Galen Data, joins Tom as his guest to discuss with live viewers and podcast listeners the design control and development process for software as a medical device (SaMD). Some of the highlights of the show include: - Galen Data’s Goal: Configurable, scalable, FDA-compliant software platform that easily and cost-effectively connects medical devices to an FDA-compliant Cloud. - Check Engine Equivalent: Galen Data’s facilitating staging platform for predictive analytics data and early integration into electronic medical record (EMR). - Input vs. Output: Design and risk controls for mechanical/hardware or software as a medical device are the same. - Design Control and Development Process: List requirements, build prototypes, and test design. Options include waterfall, agile, scrum, or sprint methods. - What’s the difference between verification and validation testing? - Verifying a spec is easy, validating it is difficult due to user requirements and actual use. - Regulatory Pathway: Documents and prototypes allow software design engineers to use tools that help produce objective evidence and make a better product. - Design History File (DHF) and Standard Operating Procedure (SOP): Document what you do, and do what you document. Follow your procedures. - SaMD Risk Analysis: Classification (I, II, and III) and categorization of objects and components as low, medium, and high software risks.

If you're like many in the medical device industry, you've probably had some questions at one time or another around the FDA's Design Control Guidance. And if you're anything like the guests on today's podcast, you've probably gone through a lot of trial and error trying to implementing them. Wouldn't it be nice if some industry vets were willing to sharing with you their proven best practices and top recommendations for implementing design controls at your medical device company, so you can avoid problems later? You know, the kinds of problems that could cost you months of runway or even stop your device from being approved by the FDA altogether? If so, today's inaugural episode of the Global Medical Device Podcast powered by greenlight.guru, is for you. Jon Speer is a medical device expert with over 16 years industry experience who's played a part in getting 40+ devices approved by the FDA, and he is the Co-founder of greenlight.guru. Michael Drues, Ph.D., is a prolific speaker and consultant to the medical device industry as well as being the President of Vascular Sciences. Join in to hear Dr. Drues and Mr. Speer share some perspectives, opinions, and experiences about various interesting aspects of Design Controls for the medical device industry, including the classic discussion about "research" versus "development" and when should Design Controls begin? They'll also cover a range of topics including: - How do larger companies take on acquisitions when there is little to no Design Control documentation? - Examples of how to manage up-classification situations, i.e., class I à class II or III and addressing Design Controls - When should Design Controls begin? - When to make the transition from "R" to "D" Buckle in, these guys really know their stuff about medical device product development and the nuances Design Controls can present.

If you're like many in the medical device industry, you've probably had some questions at one time or another around the FDA's Design Control Guidance. And if you're anything like the guests on today's podcast, you've probably gone through a lot of trial and error trying to implementing them. Wouldn't it be nice if some industry vets were willing to sharing with you their proven best practices and top recommendations for implementing design controls at your medical device company, so you can avoid problems later? You know, the kinds of problems that could cost you months of runway or even stop your device from being approved by the FDA altogether? If so, today's inaugural episode of the Global Medical Device Podcast powered by greenlight.guru, is for you. Jon Speer is a medical device expert with over 16 years industry experience who's played a part in getting 40+ devices approved by the FDA, and he is the Co-founder of greenlight.guru. Michael Drues, Ph.D., is a prolific speaker and consultant to the medical device industry as well as being the President of Vascular Sciences. Join in to hear Dr. Drues and Mr. Speer share some perspectives, opinions, and experiences about various interesting aspects of Design Controls for the medical device industry, including the classic discussion about "research" versus "development" and when should Design Controls begin? They'll also cover a range of topics including: - How do larger companies take on acquisitions when there is little to no Design Control documentation? - Examples of how to manage up-classification situations, i.e., class I à class II or III and addressing Design Controls - When should Design Controls begin? - When to make the transition from "R" to "D" Buckle in, these guys really know their stuff about medical device product development and the nuances Design Controls can present.

Diagnostic Grifols has adopted Agile practices while keeping development in compliance with regulations. In this podcast you will learn how Diagnostic Grifols has evolved its practices with the new AAMI's Technical Information Report (TIR45) which gives guidance on the use of Agile in medical device development; Diagnostic Grifols has attained significant gains in productivity with a simultaneously Agile and compliant approach; and how this type of approach could be used in other regulated industries as well. Keith Collyer and Paridhi Verma, speakers.

For most medical device companies, the design control requirements of the FDA, as defined in 21 CFR Part 820, are fundamental to the business of developing products. The challenge is how to ensure that you remain compliant to these regulatory needs while reducing the overhead in doing so. Ideally, you want to make compliance just part of "how we do business around here", and, in effect, invisible to the practitioners. This podcast will discuss approaches to make that possible. Marty Bakal and Paridhi Verma, speakers.