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Summative Podcasts

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In Summation - The Final Word

Paul Townsend

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Attorney, host and creator Paul Townsend examines some of the most famous and infamous - and often misunderstood - court cases to make headlines across America. In doing so, he provides listeners with a true and unbiased understanding of the underlying facts as the judge or jury would have heard them at the time, explains what the role of each party was, breaks down the legal arguments presented, and gives the final word on who ultimately prevailed and why.
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Data Reflections

WSWHE BOCES Data Analysis Service

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Welcome to the WSWHE BOCES Data Analysis Services BLOG! We are excited to be able to provide you with the latest news and issues as they relate to data analysis and assessment in this interactive format. Please visit often and feel free to respond to the posts. For more information on anything you see here, please visit our main webpage - www.wswheboces.org/data.
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Combinate Podcast - Combining Drugs and Devices

Subhi Saadeh

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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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Fancy as F*ck! A Sweet Cheeks Podcast

Sweet Cheeks Cabaret

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Welcome to Fancy as F*ck, A Sweet Cheeks Podcast where we explore the fancy side of you. Straight from Anchorage, Alaska - cohosts Velvet Allure and Femme Fatality are here to sensually guide you through the ups and downs of showgirl life and burlesque in the Frozen North. Episodes releasing when we want to, as ladies should. Check out our website for more info! https://www.sweetcheekscabaret.com/ Any comments, questions, and love letters can be sent to our email: podcast@sweetcheekscabaret.com
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The Creative Nonfiction Podcast with Brendan O'Meara

Brendan O'Meara

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The Creative Nonfiction Podcast with Brendan O'Meara is a weekly podcast that showcases leaders in narrative journalism, essay, memoir, documentary film, radio and podcasts about the art and craft of telling true stories. Follow the show @creativenonfictionpodcast on Instagram and Threads and visit patreon.com/cnfpod to support!
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Isaac

Isaac Reilly

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Welcome to the podcast, where amazing things happen. Cover art photo provided by Efe Kurnaz on Unsplash: https://unsplash.com/@efekurnaz
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The Future of the Administrative State in the United States - Prof Williams 44:52

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In a session that was seemingly aimed at severely limiting long standing precedent and restraining the powers of the administrative state, there were five cases focused on administrative law. From the Chevron Doctrine to the SEC and the EPA, the high court touched on many parts of the administrative state. For this episode, we are joined by Profess…
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21 - Costume Creations and Other Summations 1:05:09

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Send us love letters (texts) here! <3 Oh hey! On this episode we peel back the sequined curtain to explore the dazzling, yet demanding world of burlesque costume creation. We've also got two guests for this episode - DeeDee S. Emme and Phoebe Fabrique! They'll be taking us on a journey through their creative process, the challenges, and the emotion…
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Georgia v. Jeffery Williams (aka Young Thug) 1:02:21

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Hello Loyal Listeners, In Summation returns with a thorough explanation of one of the most truly absurd cases to take place in recent memory. Rapper/Hip Hop artist Young Thug burst into the music industry around 2013 and quickly became one of the most fresh and innovate voices in the genre. He did several collaborations with world famous talent and…
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Episode 432: Betsy Golden Kellem, Scholar of the Unusual, Closet Historian, Atavist Writer 57:02

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Betsy Golden Kellem (@bgkellem on IG) is a lawyer and historian whose "City on Fire" appears in The Atavist Magazine and chronicles a conspiracy in 1864 by northern Confederate sympathizers to burn Manhattan to the ground. Newsletter: Rage Against the Algorithm Show notes: brendanomeara.com Support: Patreon.com/cnfpod…
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156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar 33:01

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On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc. On this episode, Laxman, highlights the differences in regulatory oversight and risk management between medical devices and pharmaceuticals, the trend towards home administration of drugs, sustainability goals, and the chall…
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155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach 25:25

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On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie…
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Episode 430: Louisa Thomas Knows How to End a Story 26:53

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Louisa Thomas is a staff writer for The New Yorker and the author Louisa: The Extraordinary Life of Mrs. Adams and Mind and Matter. We talk about a profile she wrote on Nikola Jokic as well as her incredible knack for a great kicker. Newsletter: Rage Against the Algorithm Show notes: brendanomeara.com Support: Patreon.com/cnfpod…
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154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell 37:31

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On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma en…
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Social connections and social identity as a basis for learning and support: Experiences of medical students with ethnic identities - An Audio Paper with Stephanie Bull and and Rohini Terry 42:49

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Bull et al. analyze students' experiences to show that they seek individuals with whom they feel compatible to maintain ‘equilibrium’ and support both academic performance and wellbeing. Read the accompanying article here: https://doi.org/10.1111/medu.15367By Medical Education
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Physicians' lifelong learning journeys: A narrative analysis of continuing professional development struggles - An Audio Paper with Louise M. Allen 43:28

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What do physician learning journeys after formal training look like? Allen et al. used narrative analysis to explore how physicians' learning journey changes across their careers. Read the accompanying article here: https://doi.org/10.1111/medu.15375By Medical Education
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20 - Wenches and Wrenches (The Horniest Year Yet!) 1:09:40

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Send us love letters (texts) here! <3 Thar she blows! It's our annual Wenches and Wrenches episode, where we deep dive into what goes on to put on a steampunk extravaganza! There's quite a few changes to this year - new numbers, new cast, new costumes, and, oh yeah, Femme directed it this year! This is a good accompany episode - either before or af…
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Episode 429: What Does It Mean to be a 'Hungry Author'? 52:32

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Liz Morrow (@liz_morrow) and Ariel Curry (@arielkcurry) are the co-authors of Hungry Authors (@hungryauthors): The Indispensable Guide to Planning, Writing, and Publishing a Nonfiction Book (Rowman & Littlefield). They are a special team and — with their powers combined — created a wonderful guide that is tactical, practical, and informative about …
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153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio 21:56

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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system…
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‘Patient’ or ‘professional’? Negotiating accommodations and identity in fieldwork education - Interview with Tracey Edelist 16:33

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Student experiences seeking accommodations in health and human services fieldwork education show how ableist structures lead to marginalization despite legal mandates to accommodate. Read the accompanying article here: https://doi.org/10.1111/medu.15365By Medical Education
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152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh 40:48

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This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380). In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and…
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151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio 33:38

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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses: 00:00 Introduction 02:29 Understanding the FDA's New Guidance: 05:05 Challenges in Supplier Management and the 08:22 Navigating Change Management 11:43 Insi…
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19 - Stripping Down Stereotypes 45:02

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Send us love letters (texts) here! <3 "Well behaved women seldom make history." - Laurel Thatcher Ulrich We talked about burlesque and its intricate relationship with feminism this episode - something we've wanted to talk about since we created Fancy as Fuck! Check out our website for any info and show dates: https://www.sweetcheekscabaret.com/ Any…
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Episode 426: Asking for Blurbs, Unauthorized Biographies, and the Mystery of Aaron Rodgers with Ian O'Connor 1:11:44

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Ian O'Connor (@Ian_OConnor) is the author of several best-selling books. His latest is Out of the Darkness: The Mystery of Aaron Rodgers (Mariner Books). Newsletter: Rage Against the Algorithm Show notes: brendanomeara.com Support: Patreon.com/cnfpodBy Brendan O'Meara
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150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar 38:58

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On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses:00:00 Welcome to Episode 150!03:00 Challenges and Innovations in Ocular Drug Delivery09:30 Understanding Intravitreal Injections13:26 Regulatory Considerations for Ocular Products20:48 Innovations in Glaucoma Treatment29:1…
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