A Discussion about getting started building a home lab and discussing services that can be self-hosted without giving up privacy or locking you into a service you don’t control.
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If you’re addicted to Computer Hardware and technology, this podcast is for you. Hardware Addicts brings you the latest trends in tech along with brain filling tips and tricks to help you get the most out of your hardware. Join Ryan, Wendy, and Michael as we geek out on the physical technology that powers our addiction. Hardware Addicts is a podcast brought to you by the TuxDigital Network (https://tuxdigital.com/)!
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Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to li ...
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Welcome to Dankash, where amazing things happen.
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Ideas on teaching modern languages in a modern world.
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Emerging and future technologies and the trends that they are linked to will be covered on this podcast. From the more obvious tech like: AI, Robotics, Autonomous Vehicles, and The Metaverse. To less well known disruptors like: Brain-Machine Interfaces, CBDC’s, Internet of Bodies, Smart Dust, Animal Human Chimeras, 4D Printing, Under The Skin Surveillance, Bio Computers and much more. A vision of what the future may hold will be painted to alleviate some of our collective Future Shock so we ...
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143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young
29:22
29:22
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On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs and Biological Products Guidance for Industry. Industry Comments are DUE 9/29/2024.Alan Stevens is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie wit…
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1
Giving Robots the ability to smell. (With Kordel France of Theta Diagnostics)
57:42
57:42
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In today's episode, we explore the profound impact of giving robots a sense of smell with Kordel France, discussing how this breakthrough will transform industries like biotech, emergency response, and healthcare.About the Episode: For those of you who have been listening for a while in the early phase of the podcast robotics was touched on a lot w…
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The Homelab Ep. 131 – Home Desktop OS Linux, Windows, Apple.
40:54
40:54
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https://thehomelab.show/ https://lawrencesystems.com/ https://www.learnlinux.tv/ Today’s sponsor: Our merch! lawrence.video/swag https://merch.learnlinux.tvBy The Homelab Show
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142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin
30:26
30:26
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On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 01:53 Material Qualification Discussion Begins02:23 Material Qualification in Drugs vs. Devices04:00 Quality Standards in Different Industries08:54 Quality Tools and Their Applications11:22 Material Qualification and Supplier Mana…
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https://thehomelab.show/ https://lawrencesystems.com/ https://www.learnlinux.tv/ Today’s sponsor: Our merch! lawrence.video/swag https://merch.learnlinux.tvBy The Homelab Show
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141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)
23:09
23:09
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On this episode of the Combinate Podcast, I go over 6 lessons from the life and x of H. James Harrington. Dr. H James Harrington has a decorated career with 40 years at IBM, 10 years at Ernst & Young, and has held multiple executive roles at various companies since. He's written more than 55 books on performance improvement. He was the chairman and…
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1
Creating User Friendly Cryptocurrency Addresses. (With Michal 'Mehow' Popieszalski, founder of Matterfi)
53:32
53:32
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In this episode we discuss the importance of securing cryptocurrencies and how Matterfi has built a platform to domjust that About the Episode: In this episode, we explore the thrilling world of cryptocurrency and blockchain technology with Mehow, a pioneer in digital security from MatterFi. Amidst rising concerns over $200 million stolen in digita…
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1
How Bitcoin Mining Actually Supports Power Grids.
1:20:22
1:20:22
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In this episode, we explore Bitcoin mining with Thomas Duffles, discussing its role in stabilizing the power grid and its future, while gaining insights from his experience and expertise in the field. About the Episode: Welcome to today's episode of [Your Podcast Name]. In this episode, we dive deep into the fascinating world of Bitcoin mining. We …
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The Homelab Ep. 129 – Project Updates and Q&A
58:19
58:19
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https://thehomelab.show/ https://lawrencesystems.com/ https://www.learnlinux.tv/ Today’s sponsor: Our merch! lawrence.video/swag https://merch.learnlinux.tvBy The Homelab Show
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140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa
30:50
30:50
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On this episode, I was joined by Christian Espinosa CEO of Blue Goat Cyber. On this episode, Chrsitian walks through:00:00 Introduction and Guest Overview00:20 Christian Espinosa's Journey: From Air Force to Cybersecurity03:41 Medical Device Cybersecurity: Challenges and Risks05:51 Freelance to Entrepreneurship: Founding Blue Goat Cyber07:05 Cybers…
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139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh
27:43
27:43
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This is a solo episode. On this episode, Subhi goes through: 01:51 Draft FDA Guidance - Platform TechnologyDesignation Program for Drug Development Guidance for Industry 13:03 EMA Guidance - Questions & Answers for applicants, marketing authorisation holders of medicinal products and notifiedbodies with respect to the implementation of theRegulatio…
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1
How AI is Fighting Misinformation (with Alex Fink, CEO of Otherweb). Ep #145
55:04
55:04
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This episode explores how AI is revolutionizing the media landscape by tackling misinformation and enhancing the credibility of digital content. About the Episode: Today’s episode delves into the critical and timely issue of misinformation in our digital world, discussing the profound impact it has across various aspects of society, from politics t…
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https://thehomelab.show/ https://lawrencesystems.com/ https://www.learnlinux.tv/ Matt’s IG and some other board posts: https://www.instagram.com/100781/ https://www.reddit.com/r/ErgoMechKeyb… https://www.reddit.com/r/ErgoMechKeyb… My favorite Etsy stores for board kits/parts: https://www.etsy.com/shop/weirdlittle… https://www.etsy.com/shop/Worldspa…
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138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager
47:34
47:34
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On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through: 00:31 Larry's Perspective on Quality 03:21 Importance of KPIs in Management Review 04:13 Management Review and Control 09:09 Operational Framework and Business Structure 18:46 Effective Business Processes 24:42 Understanding R…
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Cybersecurity in the Age of AI (With Steve Orrin of Intel). Ep #144
1:02:48
1:02:48
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This episode delves into the evolving impact of AI on cybersecurity, exploring its implications and advancements in both private and public sectors. About the Episode: This episode explores AI's growing impact on various industries, businesses, and everyday life. With the ongoing hype around AI, marked by new releases, tools, and updates like OpenA…
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137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens
18:11
18:11
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On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, Alan walks through: 00:38 Exploring Reliability in Combination Products 01:17 The Importance of Subscribing and Feedback 01:36 Alan Stevens Shares His Expertise 02:40 Understanding Reliability: Definitions and N…
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1
2 months in El Salvador. Bitcoin and the Future (Part 2).
1:00:45
1:00:45
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A look at the new changes, policies, and thoughts that are transforming the small Central American country, El Salvador. A follow up from part 1 on a 2 month trip in the country. About the Episode: In this episode I’ll follow up on the first episode about EL Salvador but more about how things are changing AFTER the gangs had been imprisoned and the…
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136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura
39:53
39:53
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On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through: 00:29 Design Changes When No DHF Exists 03:30 Challenges and Strategies in Document Management 04:49 Improving Design Inputs and Risk Management 21:37 Leveraging Tools for Better Traceability and Compliance Charles Ve…
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1
2 months in El Salvador. Bitcoin and the Future. (Part 1).
30:13
30:13
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Marc Verbenkov shares insights from his trip to El Salvador, focusing on its historical challenges and recent societal changes to setup a part 2 where current transformations will be looked at in detail. About the Episode: In this episode, Marc Verbenkov touches on his experiences during a month-long remote work trip in El Salvador, a country that …
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https://thehomelab.show/ https://lawrencesystems.com/ https://www.learnlinux.tv/ retrobyteskuk https://www.youtube.com/channel/UCBp33nQRejZkmujCMtnPJTQ Today’s sponsor: Our merch! lawrence.video/swag https://merch.learnlinux.tvBy The Homelab Show
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135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson
41:16
41:16
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On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical. On this episode, Anthony discusses: 03:11 The Formation and Impact of the Office of Combination Products 04:16 Challenges and Changes in the Regulatory Landscape for Combination Products 07:53 Understanding FDA Titles and Organizational Struct…
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1
The Homelab Show Ep. 126 – Ubuntu 24.04 Review
34:17
34:17
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https://thehomelab.show/ https://lawrencesystems.com/ https://www.learnlinux.tv/By The Homelab Show
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134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch
41:49
41:49
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On this episode, I was joined by Richard Koch, Founder of KochSaMD. Richard discusses: 00:29 Exploring Software's Role in Medical Devices 02:29 Deep Dive into Cloud-Based Medical Devices 06:29 The Intricacies of Software Development in Medical Devices 26:33 The Future of Medical Devices in the Cloud Era 32:56 The Potential Impact of Tech Giants on …
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133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell
22:26
22:26
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On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry.Devon discusses: 02:20 The Journey to Consulting: A Year of Saying No 03:09 Advising Startups: The Role of a Consultant 05:08 The Shift to Consulting: Embracing Joy and Impact 09:21 Navigating the Startup Ecosystem: Challenges and Opportunities 13:31 Building a P…
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The Homelab Ep. 125 – Training and Certifications
48:18
48:18
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https://thehomelab.show/ https://lawrencesystems.com/ https://www.learnlinux.tv/ Comptia Cert Path https://partners.comptia.org/docs/def…By The Homelab Show
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132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner
31:11
31:11
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On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses: 00:56 Evolution of Industry Standards 02:00 The Impact of Standards on Medical Device Development 02:10 Standards and Regulatory Challenges 02:42 Standards in Medical Devices and Emerging Technologies 13:19 The Auditing…
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131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer
42:53
42:53
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On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss:- Assessing Drugs, Devices, and Combination Products for Sterility Methods- Regulatory Frameworks and EMA's Decision Tree (Link)- Novel Methods: liquid phase sterilization, ionization, physics based sterilization, high pressure s…
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130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder
32:25
32:25
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On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses: 00:58 Exploring the Impact of QMSR on Medical Device Companies 02:19 UDI Regulations 05:18 Understanding the FDA's Approach to QMSR and Compliance 18:02 The FDA's Inspection Techniques and the Future of QMSR 31:55 Where to Find Aaron and Closing Thoug…
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129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens
32:59
32:59
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On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about how reliability engineering concepts can be used for single use combination products. Why infusion pumps are susceptible to recalls. Why people call Allen captain Allen Stevens. A…
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https://thehomelab.show/ https://lawrencesystems.com/ https://www.learnlinux.tv/ My LinkedIn post about Avanti https://www.linkedin.com/posts/lawren…By The Homelab Show
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128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture
52:32
52:32
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On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso. Vin discusses: 01:35 Journey from Premed to FDA Investigator: VIN's Story 07:25 Understanding the Impact of QMSR on Industry 16:24 The FDA's Approach to Inspections and Compliance 27:45 The Shift Towards Quality Culture in F…
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1
The Future of Marketing (With David Rice and Martin Waxman) Ep #141.
50:27
50:27
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How are emerging technologies like generative AI going to impact marketing and the consumers ads are targeting? About the Episode: One of the interesting things that seems to be coming together with the growing number of podcasts is how numerous new technologies and the emerging sectors they are creating will impact or in some ways force an evoluti…
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127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal
48:25
48:25
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48:25
On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk". In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode covers the confusion surrounding the mandatory nature of risk management in particular and we spend the seco…
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1
Tech for Renewable Insect Production (With Martin Pike) Ep #140.
59:53
59:53
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We delve into the fascinating world of insect farming, exploring its significance in addressing food security and nutrition challenges, and how it offers a sustainable alternative to traditional livestock farming. And this week we focus on another insect the black soldier fly as opposed to crickets or other insects. About the Episode:Environmental …
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1
The Homelab Show Episode 123 – Special Guest Techno Tim
53:23
53:23
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https://thehomelab.show/ The sponsor for today’s episode https://www.linode.com/homelabshow https://lawrencesystems.com/ https://www.learnlinux.tv/ https://www.youtube.com/@TechnoTimBy The Homelab Show
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126 - Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd
35:54
35:54
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On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses: 01:02 Venturing into Combination Products 02:46 Andy's Journey into Healthcare Space 04:48 Challenges in Deep Brain Stimulation 08:55 The Impact of working with Andy Grove 10:42 The Struggle with Parkinson's Disease 13:20 The Speed of Product Deve…
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The Homelab Show Ep. 122 – Why the Fundamentals are Important with Special Guest Veronica
59:50
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https://thehomelab.show/ The sponsor for today’s episode https://www.linode.com/homelabshow https://lawrencesystems.com/ https://www.learnlinux.tv/ https://www.youtube.com/@VeronicaExpl…By The Homelab Show
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125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh
42:04
42:04
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42:04
On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024. 0:00 Introduction 05:09 Initial Reactions to the idea of the QMSR 06:57 History of the Device cGMP's, QSR, and QMSR 11:52 What's changing in 21 CFR 820? 24:59 What's changing in 21 CFR …
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1
Virtual Reality for Learning and Development (With Tony Bevilacqua)
56:31
56:31
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This episode explores the transformative role of XR/VR in enhancing learning and development, through innovative technology applications and insights into future trends in training simulations.About the Episode: In this insightful episode, we delve into the evolution and impact of Extended Reality (XR) and Virtual Reality (VR) on the Learning & Dev…
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1
The Homelab Show Ep. 121 – Special Guest Level1 Techs
1:03:47
1:03:47
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https://thehomelab.show/The sponsor for today’s episode https://www.linode.com/homelabshowhttps://lawrencesystems.com/https://www.learnlinux.tv/ https://www.level1techs.com/By The Homelab Show
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