This is an NBA draft podcast for the following people: casual fans looking for an easy way into the NBA draft. Draft nerds looking for draft content that's more entertaining than the traditional scouting report-y stuff. Anyone looking to relive heroic or cartoon-y youth basketball folklore. People that play 2ks MyLeague or $15 build ur team games, any fake GM thing The High & Dry Draft pod is for stoned people mesmerized by YouTube mixtapes of the next crop of tantalizing prospects and espec ...
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Welcome to Harness Up with Haste Draft Horses & Mules Podcast, where we talk all things related to these magnificent animals. From their history and uses to training and care, we cover it all. Join us as we chat with experts and enthusiasts in the field, share stories and tips, and explore the world of draft horses and mules. Whether you're a seasoned owner or just curious about these gentle giants, this podcast is for you. So harness up and join us for some lively discussions about these Go ...
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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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News, interviews, and history with newsmakers and environmental advocates, focused on parks and public lands across the American West. Produced by the Center for Western Priorities, formerly known as Go West, Young Podcast.
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We are a comedy podcast that offers you our wisdom and powerful insights on everyday issues. As always thanks for listening.
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146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens
35:58
35:58
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On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final steps such as backfilling and stoppering. David also explores the different considerations for lyophilization, the impact of var…
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Hitting the trail with Disabled Hikers founder Syren Nagakyrie
22:12
22:12
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22:12
Kate and Aaron talk to Syren Nagakyrie, founder and director of Disabled Hikers, a nonprofit group seeking to make the outdoors more accessible for people with disabilities. Nagakyrie has been outspoken about the tokenization of disabled hikers by U.S. Senator Mike Lee, who recently filed a bill called the Outdoor Americans with Disabilities Act th…
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145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi
40:28
40:28
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40:28
On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reaut…
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Trinity Vandenacre - Life in the West
1:12:31
1:12:31
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Today we're thrilled to have Trinity Vandenacre, an "entrepreneur cowboy" with deep roots in the ranching industry, join us. On this episode, we'll talk about variety of topics from the benefits of feeding horses straight alfalfa to the ever-evolving draft horse industry. You'll hear fascinating insights about the rugged landscapes of Montana, the …
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144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo
35:36
35:36
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35:36
On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery. David and I discuss: 00:00 Introduction and Guest Overview00:04 David DeSalvo's Career Journey02:13 Understanding Injection Systems04:22 Early Career at BD10:51 Transition to SHL17:50 Starting a New Venture24:54 Experience at …
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Eric Reed ( Rich Strike ) 148th Kentucky Derby Trainer
55:00
55:00
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55:00
In this episode of "Harness Up," host Steven Haste interviews Eric Reed, the winning trainer of Rich Strike, the 148th Kentucky Derby champion. They discuss the significant challenges of driving horses in public areas, recounting a dangerous traffic incident and the public's response. Eric shares his profound connection to horse racing, inspired by…
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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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29:22
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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How an Instagram ‘joke’ turned into an outdoor LGBTQ community
46:30
46:30
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46:30
Aaron and Kate talk to Dr. Hitesh Tolani, creator of the Gays of National Parks Instagram account, which is aimed at fostering community among LGBTQ people through a love of the outdoors. Hitesh began the account as a joke in 2022, but it has since grown into a community with over 15,000 followers. Hitesh talks about how the group is fostering conn…
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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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30:26
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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Reporter Murphy Woodhouse on the future of wildfire season
58:20
58:20
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58:20
Kate and Aaron are joined by Boise State Public Radio’s Murphy Woodhouse, a reporter with the Mountain West News Bureau collaborative. Murphy covers wildfires and wildfire policy across the West, informed by his past experience as a wildland firefighter. In a wide-ranging discussion, Murphy talks about the bleak state of wildfire pay, the possibili…
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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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23:09
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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Sounds of Appalachia: Bluegrass, Mules & Horses & Stories of Old Time Ways and Traditions
58:35
58:35
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58:35
In this episode, Timmy Jones, owner of Rusty Spur Trail Rides, reminisces about the good ol' days of coon hunting under the moonlit sky and shares his journey from a musician to a full-time trail ride business owner. Get ready to hear stories of tradition, change, and the great outdoors. Find us online at DraftHorsesAndMulesForSale.com…
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Journey to the Kentucky Oaks: Michael McMillan and Where's My Ring
37:22
37:22
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Today, we're venturing into the thrilling world of horse racing with our special guest, Michael McMillan, the proud owner of the racehorse "Where's My Ring," set to compete in the prestigious Kentucky Oaks. Join us as Michael shares his unexpected journey into horse ownership, balancing it with his busy life, and the touching story behind his raceh…
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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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30:50
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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The proposed Mimbres Peaks National Monument would add protections for lands overseen by the Bureau of Land Management in Luna County, New Mexico near the city of Deming. The collaborative effort is locally-led by elected leaders, business owners, economic development advocates, hunters, youth leaders, conservationists, and students. The proposal w…
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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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Kentucky Derby Halter Maker, Pinkston's Turf Goods
34:22
34:22
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We dive deep into the rich history of Pinkston's, a family business that has been a cornerstone in the horse industry for decades. Enjoy fascinating tales about mules in the military, the craftsmanship of Derby halters, and the evolution of horse racing regulations. Learn about the family's proud legacy, their renowned custom-made racing tack, and …
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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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47:34
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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Aaron and Kate are joined by Kristen Miller, Executive Director of the Alaska Wilderness League, to talk about some big steps to protect public lands in Alaska made by the Biden administration this spring. They include increased protections for 13 million acres inside the National Petroleum Reserve-Alaska, as well as the cancellation of a proposed …
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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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18:11
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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PRB Bull Rider JaCauy Hale Bucks His Way to the Top
45:58
45:58
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45:58
Here's a surprise for you aspiring PBR bull riding enthusiasts! Learn the unexpected insights from a casual and informal chat with professional bull rider JaCauy Hale. From training and equipment essentials to unforgettable rodeo experiences, this is where your bull riding journey begins. Dive into this uncharted podcast territory and discover 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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39:53
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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Behind the scenes of the Bears Ears draft management plan
25:46
25:46
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25:46
Aaron and Kate are joined by Davina Smith, who represents the Navajo Nation on the Bears Ears Inter-Tribal Coalition, and Lauren Henson, who is the Collaborative Management and Tribal Support Specialist for the Bears Ears Inter-Tribal Coalition, to talk about the Bears Ears draft monument management plan, which came out in March. We talk about how …
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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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41:16
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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Cowboy Wisdom w/ Dewayne Noel of Dry Creek Wrangler School
1:29:38
1:29:38
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1:29:38
Dewayne Noel of Dry Creek Wrangler School and host Steven Haste dive deep into the fascinating world of mules, horse breeding, and the unique challenges and experiences that come with ranching and training these remarkable animals. Dewayne shares his personal journey, from riding Mongolian horses in China to launching a horseback safari business in…
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In this episode the guys and guest Mr. Zac call Texas Roadhouse to see how many rolls are in a standard basket. Also, we take a Cosmopolitan test from the 90s to find out if we are in fact "Balls-out Badass" or "Too Good for Your Own Good" and to finish the season a draft of outdoor activities. Check out the twitter(x) polls Thanks for listening, P…
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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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41:49
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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In this episode we will cover our eclipse experience, then we will get to know our first guest Mr. Zac and then a live call to Texas Roadhouse??? why??? Check out the twitter(x) polls Thanks for listening, Please like and follow us on twitter (x) @internationalhouseofpodcast also on Tik Toc @int.houseofpodcast…
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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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22:26
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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Why April was a huge month for public lands
38:33
38:33
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38:33
Kate and Aaron are joined by the Wilderness Society’s Michael Carroll and Justin Meuse to talk through a handful of federal regulations, or rules, that were finalized in late March and April. These rules touch on everything from methane waste on public lands to ecosystem restoration to caribou herds in Alaska. Some of these rules are already in eff…
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Empowering Equestrians: Ken McNabb's Influence on Horsemanship
53:46
53:46
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53:46
Host Steven Haste is joined by renowned cowboy Ken McNabb. Ken speaks about his extensive experience in the horse industry, his TV show appearances, and the significant influence of "Yellowstone" on horse market trends. Ken is passionate about educating equestrians through his various horsemanship clinics and emphasizes the importance of well-train…
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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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31:11
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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Kate and Aaron are joined by Trout Unlimited CEO Chris Wood, who has been with TU for twenty years, following a career as chief policy director at the U.S. Forest Service during the Clinton administration. Chris talks about how an influx of federal funding for ecosystem restoration is supercharging the group’s work reconnecting streams and rivers, …
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Jason lucks out, we learn about the cops drinking game, and RAT WARS???? Check out the twitter(x) polls Thanks for listening, Please like and follow us on twitter (x) @internationalhouseofpodcast also on Tik Toc @int.houseofpodcasBy Brad
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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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42:53
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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Preparing Equine Partners for Mounted Patrol Duty
43:15
43:15
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43:15
Justin Hardy, a dedicated member of the Louisville Metro Police Department's mounted patrol division, joins Steven Haste on the podcast. With 18 years of experience at the department, including 14 years spent riding on horseback, Justin brings a wealth of knowledge and expertise in training police horses for mounted patrols. His passion for horses …
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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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32:25
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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Brad finishes dry February. The guys change some key movie star rolls, and some beer reviews from our own James Parkview !!! Check out the twitter(x) polls Thanks for listening, Please like and follow us on twitter (x) @internationalhouseofpodcast also on Tik Toc @int.houseofpodcasBy Brad
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Talking public lands extremism with Betsy Gaines Quammen
1:02:52
1:02:52
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Kate and Aaron are joined by author Betsy Gaines Quammen to talk about public lands and extremism. Betsy has written two books about extremism in the West. Her first, American Zion, looks at the connection between Mormonism and extremism. Her second book, True West, which came out last year, digs into the myths that define the West. News Interior r…
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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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32:59
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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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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52:32
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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we have a friendly beer draft and a chat about myspace! Check out the twitter(x) polls Thanks for listening, Please like and follow us on twitter (x) @internationalhouseofpodcast also on Tik Toc @int.houseofpodcastBy Brad
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someone is trying to turn our house into a bar
55:06
55:06
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55:06
pre work out farming and you guessed it home remodel!!! Check out the twitter(x) polls Thanks for listening, Please like and follow us on twitter (x) @internationalhouseofpodcast also on Tik Toc @int.houseofpodcastBy Brad
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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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Kate and Aaron are joined by three members of the reporting team behind, Lithium Liabilities, a groundbreaking investigation into how lithium mining could affect the West’s water supply. Emma Peterson, Morgan Casey, and Lauren Mucciolo are part of a large team of editors, photographers, and reporters who worked on the investigation at the Howard Ce…
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Have you ever drove a riding lawnmower? check out the twitter(x) polls Thanks for listening, please like and follow us on twitter (x) @internationalhouseofpodcast also on Tik Toc @int.houseofpodcastBy Brad
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Host Steven Haste shares his passion for these magnificent animals and provides a glimpse into his life, work, and connections across the country. From heartfelt personal stories to the diverse uses of draft horses and mules, as well as the tight-knit community around them, Steven offers an engaging and insightful look at the world of these incredi…
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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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35:54
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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Welcome to the Haste Draft Horses & Mules Podcast, where we talk all things related to these magnificent animals. From their history and uses to training and care, we cover it all. Join us as we chat with experts and enthusiasts in the field, share stories and tips, and explore the world of draft horses and mules. Whether you're a seasoned owner or…
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Kate and Aaron are joined by pollsters Lori Weigel and Dave Metz to discuss the 14th Annual Colorado College State of the Rockies Project Conservation in the West poll. The poll surveys voters in Wyoming, Montana, Idaho, New Mexico, Arizona, Nevada, Utah and Colorado on their environmental views. This year, it found support for conservation […] The…
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