Podcasts about dhf

What's the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?In this episode of Let's Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical device design. Learn how these two approaches tackle product realization, why they're not interchangeable, and how both are essential when building safe, effective, and compliant combination products.Whether you work in drug development, medical devices, or the space in between, this episode will help you:-Understand the regulatory foundations of QbD (ICH Q8) and design controls (FDA 21 CFR 820.30)-Learn the core tools and deliverables (like CQAs, QTPP, design verification & validation, and risk assessments)-See how each system addresses user needs, therapeutic effects, and process control-Apply both systems effectively in combination product developmentTimestamps:00:00 – Intro: Why Compare QbD and Design Controls?01:31 – Philosophical Differences: Process vs. Product Control03:10 – Practical Examples: Drugs vs. Devices05:13 – Origins and Frameworks: ICH Q8 and Design Controls Regulation06:46 – Deep Dive: What Are Design Controls? (Inputs, Outputs, DHF, V&V, Transfer)11:51 – What Is Quality by Design (QbD)? (QTPP, CQAs, Design Space, DOE)15:39 – Final Takeaways: How to Use Both in Combination ProductsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.------------------------ICH Q8, Q9, Q10, and Q12ISO 14971 Risk ManagementDifferences between usability engineering and clinical trialsThe role of control strategies and process monitoring in pharmaRelevant for:Regulatory affairs professionalsQuality engineers in pharma and medtechDrug/device development teamsAnyone preparing for combination product submissions or audits

Listen for your chance to go the Digital Health Festival on us – with thanks to the DHF team. #Muchlove

In this episode Hosts Sam Sears, and Rick Grace (The DHF church liaison) interview Phil Claycomb, founder of Nexus church planting. They discuss questions like, “Why plant new churches?” and talk about the general mission of the church. They also discuss the partnership between DHF and Nexus, in planting The Stone Christian Church. You can learn more about Nexus at nexus.us You can learn more about The Stone at thestone.cc Nexus has offered a matching grant to any DHF Church that wants to support the Stone. You can give via DHF by visiting discipleheritage.org/give. Select "Other" and add “The Stone Church Plant” in the memo line. You can also give directly to The Stone by going to “Next Steps” at thestone.cc or directly here.

El Dominican House Fest (DHF) conecta a la diáspora dominicana en Nueva York, Nueva Jersey y Filadelfia con oportunidades inmobiliarias exclusivas en República Dominicana. En su última edición, generó más de 48 millones de dólares en negocios y para 2025 busca romper récords. Conversamos con Edward Saldaña, empresario y organizador del evento, sobre el impacto y proyecciones del DHF.

In this episode of *Let's Combinate*, Subhi delves into the critical distinctions between drug tech transfer and device design transfer, especially pertinent to combination products. Sue comprehensively outlines the regulatory frameworks governing each process—ICH Q10 for drug transfer and ISO 13485 for device design transfer. The episode discusses key elements like analytical method transfer and process validation for drugs, and the DHF and risk management in device design. Subhi looks into the differing complexities, regulatory submissions, and validation requirements for both processes. The episode concludes with commercializing combination products, emphasizing project management, regulatory submissions, and post-market surveillance. 00:00 Introduction to Combination Products 00:55 Understanding Drug Tech Transfer 04:04 Exploring Device Design Transfer 08:49 Key Differences Between Drug and Device Transfers 14:30 Commercialization of Combination Products 17:54 Conclusion and Final Thoughts Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.

Новости на радио «Русские Эмираты» в Дубае: - Dubai Home Festival 2024 (DHF) объявил о проведении трехдневной суперраспродажи, предлагающей скидки до 90%, благодаря чему жители получат идеальную возможность обновить свои дома. - По прогнозам МВФ, в 2024 году реальный ВВП ОАЭ останется на отметке в 4%, а в 2025 году вырастет до 5,1%, согласно данным отчета World Economic Outlook (WEO).

Welcome back to the People's Guild.  The bus is back! @fatjimmy joins us as we sit down with @azircon to discuss a slew of the current happenings.  We talk through the DHF proposal, potential implications and what we can do for Hive.  Welcome back to the bus, folks, and enjoy the show!Some technical difficulties: apologies in advance for the poor quality on my mic for the first half of the show************************************************************************* Follow us elsewhere: Peakd: https://peakd.com/@thepeoplesguild  Patreon: https://patreon.com/thepeoplesguild Twitter: https://twitter.com/thepeoplesguild General: https://linktr.ee/thepeoplesguild Check out the official sponsor of the People's Guild, the People's Market over at Aqualis: splinterlands.aqualis.io

DHF hosts Sam and Chris interview missionary, speaker, and trainer, Olin Giles from Radical Truth about his ministry to Muslims; and particularly his time in #Dearborn, Michigan which has become famous for having the highest concentration of Muslims in the U.S. Website: https://www.radicaltruth.net Donate: https://www.radicaltruth.net/donate

Apologist Evan Minton joins Sam and DHF board chair Drew McClellan to discuss the Maximal Data Argument for the Resurrection. This argument is an increasingly alternative to the “Minimal Facts Argument” championed by Dr. Gary Habermas and others. In the minimal facts argument, you demonstrate that the Resurrection happened by appealing to what is accepted to most scholars, but in Evan's words in the Maximal Data Approach, “no piece of evidence is off the table.” The argument takes the time to establish the authors of the gospels and the gospels authenticity and goes from there. Those who teach the Bible from the pulpit or in a small group, can sprinkle some of the evidence mentioned into their lessons or messages, and when sharing your faith, this information can answer sincere questions and encourage people to respond to truth. You can follow Evan' work at  cerebralfaith.net/ You can learn more about the Maximal Data argument here: https://cerebralfaith.net/my-defend-talk-making-the-maximal-data-argument-for-jesus-resurrection-attractive/ Resources Mentioned Lee Strobel's Case for Christ The Case for the Resurrection of Jesus by Gary Habermas and Mike Licona  I Don't Have Enough Faith to be an Atheist by Frank Turek and Norma Giesler The Fate of the 12 Apostles Sean McDowell Undesigned Coincidences by J.J. Blunt The Works of Timothy McGrew timothymcgrew.com/ and his Wife Lydia Mcgrew lydiamcgrew.com/ Testify by Erik Manning youtube.com/@TestifyApologetics Trinity Radio with Braxton Hunter youtube.com/@BraxtonHunter

A més a més resum del Catalunya-Paraguai i de tota l'actualitat esportiva. Inclosa la la Champions d'hoquei patins, la Ok lliga Iberdrola, la LF Endesa, la DHF de waterpolo i la Primera Iberdrola de futsal entre d'altres

Un nuevo episodio del podcast de Penalty Stroke con Xantal Giné (23 de septiembre de 1992). Xanti vivió desde los cuatro años en Rubí. Y sus primeros lazos con el deporte se formaron en la natación y el voleibol. Un compañero de trabajo de su madre les habló del hockey y del Linia 22 de Terrassa (la sección de sala la desarrolló en Les Fonts). Y allí comenzó su pasión por el deporte al que se abrazó con ocho años. En aquel club ‘familiar' estuvo hasta los dieciséis años cuando pasó al CD Terrassa y donde jugó hasta la temporada 2012-2013. Posteriormente se fue al Polo donde coincidió con grandes jugadoras como Gigi Oliva, Sole Contardi, María Gómez, Olaya Piñeiro, Julieta Franco,… Ganamos la Copa de la Reina el primer año y fuimos segundas en liga.  En paralelo se fue desarrollando su recorrido en la selección. Ese universo lo fue descubriendo poco a poco en el Terrassa cuando viajaba con el juvenil o el equipo de DHF. En un campeonato autonómico en Valencia ya le llamó la atención Salva Induráin. Fue quemando etapas con la sub'18 y la sub'21 y debutó con la absoluta en Johanesburgo (Sudáfrica), si bien la entrada ya se dio en Valencia, lugar talismán para las RedSticks. ⁠Marta⁠ le pregunta a Xanti sobre sus rutinas antes de un partido. La forma en la que se prepara, como afronta el día o las horas antes de disputar una competición. Son muchos los jugadores y jugadoras que tienen ciertas supersticiones a la hora de vestirse o simplemente buscar momentos de concentración. ¡Suerte Xanti!

DHF board members Sam Sears and Drew Mcclellan interview pastor, and chaplain Monte Bowers. He serves as a chaplain for the Army National Guard and recently spent time serving in Djibouti, Africa. Resources Peter Scazzero's Emotional Healthy Leader

Now live at the Blur Podcasts, the German DJ and producer - Ben Zimmermann! Having first come to our attention a few years ago with his debut house EP "Serendipity" released at label House Trip Recording, he has since then released a flurry of tracks on labels such as Deep Fix Recordings, Soul Room Records, with the last one being released at our friend T.Markakis label brand new label - DHF. Ben Zimmermann is also a wonderful DJ, known as a "crate digger" with many understated tracks permeating his sets, which is why we invited the producer from Fürth to be our guest for the 139th edition of the Blur Podcasts, which is now live on our Soundcloud, Youtube and Apple Podcasts pages. Soundcloud: https://soundcloud.com/blur-records/blur-podcasts-139 Youtube: https://youtu.be/CQmgq_vgn6I Apple Podcasts: https://itunes.apple.com/us/podcast/blur-records-podcasts/id1446494618 Make sure you follow Ben Zimmermann in the links below: https://soundcloud.com/benzimmermann https://www.instagram.com/benzimmermannhouse https://www.facebook.com/BenZimmermannMusic https://twitter.com/BenZimmMusic https://linktr.ee/BenZimmermann

Link to bioRxiv paper: http://biorxiv.org/cgi/content/short/2023.06.26.546542v1?rss=1 Authors: Cook, A. A., Leung, T. C. S., Rice, M., Nachman, M., Zadigue-Dube, E., Watt, A. J. Abstract: Spinocerebellar ataxia type 6 (SCA6) is a rare disease that is characterized by cerebellar dysfunction. Patients have progressive motor coordination impairment, and postmortem brain tissue reveals degeneration of cerebellar Purkinje cells and a reduced level of cerebellar brain-derived neurotrophic factor (BDNF). However, the pathophysiological changes underlying SCA6 are not fully understood. We carried out RNA sequencing of cerebellar vermis tissue in a mouse model of SCA6, which revealed widespread dysregulation of genes associated with the endo-lysosomal system. Since disruption to endosomes or lysosomes could contribute to cellular deficits, we examined the endo-lysosomal system in SCA6. We identified alterations in multiple endosomal compartments in the Purkinje cells of SCA6 mice. Early endosomes were enlarged, while the size of the late endosome compartment was reduced. We also found evidence for impaired trafficking of cargo to the lysosomes. As the proper functioning of the endo-lysosomal system is crucial for the sorting and trafficking of signaling molecules, we wondered whether these changes could contribute to previously identified deficits in signaling by BDNF and its receptor tropomyosin kinase B (TrkB) in SCA6. Indeed, we found that the enlarged early endosomes in SCA6 mice accumulated both BDNF and TrkB. Furthermore, TrkB recycling to the cell membrane in recycling endosomes was reduced, and the late endosome transport of BDNF for degradation was impaired. Therefore, mis-trafficking due to aberrant endo-lysosomal transport and function could contribute to SCA6 pathophysiology through alterations to BDNF-TrkB signaling, as well as mishandling of other signaling molecules. Deficits in early endosomes and BDNF localization were rescued by chronic administration of a TrkB agonist, 7,8-DHF, that we have previously shown restores motor coordination and cerebellar TrkB expression. The endo-lysosomal system is thus both a novel locus of pathophysiology in SCA6, and a promising therapeutic target. Copy rights belong to original authors. Visit the link for more info Podcast created by Paper Player, LLC

Scott Mcnay interviews Wayne Kent and Jan Barczuk after their return from Poland providing humanitarian aid on the ground. Wayne is the pastor emeritus of First Christian Church Decatur Illinois, and former Executive Director of DHF. Jan Barczuk is a missionary with Pioneer Bible Translators. They are asking listeners to pray for the end of the war and if you feel led, you can join DHF in providing humanitarian aid. DHF, and others connected to DHF have raised over $300,000 and you can join them by heading to discipleheritage.org/give and selecting the “Ukraine” option.

Scott and Sam interview Dr. Ellen Moma, who is completing her time in vocational ministry. She shares with us her most important takeaways for those still serving. Beyond being a Senior Pastor, Ellen is also a board member of DHF, experienced with conflict resolution and church consulting.

DHF board members, Scott Mcnay and Drew McClellan, share 3 types of recommendations that may help you grow with your ministry. Book recommendations Scott McKnight's The King Jesus Gospel Scott McKnight's A Church Called Tov Andy Crouch's The Life We Are Looking For Podcast Recommendations Unbelievable  with Justin Brierley Ask N.T. Wright Anything premierinsight.org Telegraph's Daily Ukraine Podcast Other Resources N.T. Wright's commentary on Romans ntwrightonline.org Anthony C. Thiselton's commentary on 1 Corinthians If you would like to support Ukrainian refugees in Poland, you can do so, by visiting discipleheritage.org/give and selecting the Ukraine option.

Hvad er egentlig de optimale rammer for udvikling af håndboldtalenter? Hvordan ser det optimale miljø ud? Og hvad kan vi lære om børne- og ungdomshåndbold fra den nyeste forskning indenfor talentmiljøer? Alt det giver professor Kristoffer Henriksen sit bud på her. Hans bog ”Talentudviklingsmiljøer i verdensklasse” er blevet en bestseller, og få har som han været med til at præge diskussionen om talentudvikling. Blandt andet spiller hans tanker en rolle i DHF's nye talentstrategi. Hør ham her i en samtale om, hvad håndbolden kan lære fra forskningen om de optimale rammer for talentudvikling. Gæst: Kristoffer Henriksen Vært: Thomas Ladegaard *Udsendelsen er sponsoreret af Sparekassen Kronjylland*

I denne uge offentliggjorde Dansk Håndbold Forbund en ny talentstrategi. Strategien dumper lige ned i en tid, hvor der er stort røre og diskussion om talentudvikling og eliteidræt. Og på et tidspunkt hvor både kvinde- og herrelandsholdet står historisk stærkt. Hvad er strategien? Hvad skal den løse? Hvilke forandringer er der på vej? Og hvorfor er der overhovedet brug for en ny talentstrategi, når det går så godt på A-landsholdene lige nu? Det spurgte vi DHF's talentchef Søren Skaastrup Frydendal om. I en samtale, hvor vi også kommer ind på den øjeblikkelige sag om vejninger og de unge spilleres trivsel. Gæst: Søren Skaastrup Frydendal Vært: Thomas Ladegaard *Udsendelsen er sponsoreret af Sparekassen Kronjylland*

DHF, DMR, and DHR are easy to mix up when you're just using the abbreviations – they sound a lot alike! And they are connected. But it's important to understand the differences between them as well as how they interact with each other.Medical Device Guru Laura Court joins the podcast today to discuss these three documents – what you need to know about them, what to do with them, and why it matters. Listen to the episode to learn how Laura thinks about best practices, what companies get wrong, and how to improve when dealing with these three different kinds of documentation.Some of the highlights of this episode include:DHF vs. DMR vs. DHRWhat's involved with the design history fileRecommendations for retaining the design history fileThe difficulties of paper filesWhat device master records areMaking sense out of device history recordsWhat goes into the DHR per the FDAHow engineers can do a better job of the feedback processThe change control process to update the DMRLaura's additional advice about documenting earlyMemorable quotes from Laura Court:“I am on the onboarding and implementation side of our team for the gurus here, so I help get our customers started in the software.”“Your design history file is truly the history of how your product was developed.” “Don't assume that you know everything. Even if you've been reading your DHF, you're not going to know everything.”“Everything should go through document control.”Links:Laura Court LinkedInDesign History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?Etienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

De seneste måneder har budt på et utal af nyheder om spillere og trænere, der skifter klub. Både med øjeblikkelig virkning - og for den kommende sæson. Vi samler op på det meste sammen med Martin Albertsen. Vi diskuterer bl.a. hvad pokker der foregår omkring landstræner Jesper Jensens kontraktforhandlinger med DHF, og hvad en fyring egentlig gør ved en træner. Undervejs er vi også godt omkring den danske liga og afslutningen på gruppespillet i Champions League. Her er et overblik over udsendelsen: 00:00 Nyheder om spillere og trænere 16:00 Situationen omkring Jesper Jensen og det danske landshold 23:00 Om at være træner i udlandet - og om at håndtere en fyring 32:00 Den danske liga er (måske) ved at sætte sig 45:49 Champions League, Odense og Esbjerg jagter gode placeringer 58:40 Åbent redaktionsmøde om matchfixing skandalen Gæst: Martin Albertsen Vært: Thomas Ladegaard *Udsendelsen er sponsoreret af Sparekassen Kronjylland*

Scott and Sam interview Wayne Kent in this second installment focused on hiring. Wayne is pastor emeritus and FCC Decatur and former executive director of DHF. In this episode, we lean on his broader experience with other churches to learn about the process of hiring a new senior lead, or solo pastor. Wayne speaks both about potential candidates for being a new pastor, as well as to the elders who would hire them.

Nu kom de store dramaer og intense opgør. I hvert fald i tre af de fire VM-kvartfinaler. Med en suveræn indsats kørte de danske herrer det ungarske hold ud af Tele2 Arena på “røv og albuer”. Forude venter Spanien i en fjerde semifinale i træk ved en slutrunde mellem de to hold. I den anden semifinale tørner Sverige og Frankrig igen sammen. Denne gang ser Frankrig stærke ud. Og selv om Sverige har fordel af hjemmebanen, kan tabet af Gottfridsson være det, som tipper kampen over til fransk fordel. Det bliver kort og godt to uhyre intense og tætte semifinaler, vi kan se frem til. Med vores faste eksperter Sonni Larsen og Jesper Fredin taler vi kvartfinalerne igennem, og ser frem mod fredagens semifinaler. Undervejs kommer vi også forbi Jordi Riberas optræden på DHF's toptræner symposium i Vejle i juni. Der var meget på hjerte efter nogle intensive kvartfinaler. Her får du overblikket over uddannelsen: - 4:00 Norges kvartfinale mod Spanien - ikke mindst afslutningen på den ordinære spilletid - 25:40 Danmarks kvartfinale mod Ungarn og det “hurtige og moderne spil” - 36:56 Danmark mod Spanien - “vanvittigt taktisk opgør” venter os - 59:30 Frankrig mod Sverige - målmændenes kamp og kollektivet overfor individet Gæster: Sonni Larsen og Jesper Fredin Vært: Thomas Ladegaard *Udsendelsen er sponsoreret af Sparekassen Kronjylland*

In this episode, Scott and Sam interview Wayne Kent, Former Executive Director of DHF and pastor Emeritus of First Christian Church Decatur. Wayne shares lessons learned from hiring a large number of staff throughout his ministry. Wayne encouraged us to ask questions about the following six topics; Scripture, Salvation, Baptism, The Holy Spirit, Women in Ministry and Sexual ethics. The answers would help clarify if the person was in alignment with the church on these important issues. Wayne mentions a few websites to place job openings: churchstaffing.com chemistrystaffing.com

123è aniversari del Barça.Anàlisis del Barça - Bayern i l'Atlético de Madrid - BarçaCopa de la ReinaResultats del KH7 Granollers, DSV Sant Cugat, Rugby Sant Cugat, la DHF de waterpolo i la liga Iberdrola d'hoquei patins

Dr. Ya-Jen Chiu from the Department of Life Science at National Taiwan Normal University in Taipei, discusses a research paper she co-authored that was published by Aging (Aging-US) in Volume 14, Issue 18, entitled, “Novel TRKB agonists activate TRKB and downstream ERK and AKT signaling to protect Aβ-GFP SH-SY5Y cells against Aβ toxicity.” DOI - https://doi.org/10.18632/aging.204306 Corresponding authors - Chiung-Mei Chen - cmchen@cgmh.org.tw, Ying-Chieh Sun - sun@ntnu.edu.tw, Guey-Jen Lee-Chen - t43019@ntnu.edu.tw Video - https://www.youtube.com/watch?v=1rT96K9VeZw Transcript - https://aging-us.net/2022/11/01/behind-the-study-novel-trkb-agonists-activate-trkb-and-downstream-erk-and-akt-signaling/ Abstract Decreased BDNF and impaired TRKB signaling contribute to neurodegeneration in Alzheimer's disease (AD). We have shown previously that coumarin derivative LM-031 enhanced CREB/BDNF/BCL2 pathway. In this study we explored if LM-031 analogs LMDS-1 to -4 may act as TRKB agonists to protect SH-SY5Y cells against Aβ toxicity. By docking computation for binding with TRKB using 7,8-DHF as a control, all four LMDS compounds displayed potential of binding to domain d5 of TRKB. In addition, all four LMDS compounds exhibited anti-aggregation and neuroprotective efficacy on SH-SY5Y cells with induced Aβ-GFP expression. Knock-down of TRKB significantly attenuated TRKB downstream signaling and the neurite outgrowth-promoting effects of these LMDS compounds. Among them, LMDS-1 and -2 were further examined for TRKB signaling. Treatment of ERK inhibitor U0126 or PI3K inhibitor wortmannin decreased p-CREB, BDNF and BCL2 in Aβ-GFP cells, implicating the neuroprotective effects are via activating TRKB downstream ERK, PI3K-AKT and CREB signaling. LMDS-1 and -2 are blood-brain barrier permeable as shown by parallel artificial membrane permeability assay. Our results demonstrate how LMDS-1 and -2 are likely to work as TRKB agonists to exert neuroprotection in Aβ cells, which may shed light on the potential application in therapeutics of AD. Sign up for free Altmetric alerts about this article - https://aging.altmetric.com/details/email_updates?id=10.18632%2Faging.204306 Keywords - aging, Alzheimer's disease, TRKB agonists, Aβ, neuroprotection, therapeutics About Aging-US Launched in 2009, Aging-US publishes papers of general interest and biological significance in all fields of aging research and age-related diseases, including cancer—and now, with a special focus on COVID-19 vulnerability as an age-dependent syndrome. Topics in Aging-US go beyond traditional gerontology, including, but not limited to, cellular and molecular biology, human age-related diseases, pathology in model organisms, signal transduction pathways (e.g., p53, sirtuins, and PI-3K/AKT/mTOR, among others), and approaches to modulating these signaling pathways. Please visit our website at https://www.Aging-US.com​​ and connect with us: SoundCloud - https://soundcloud.com/Aging-Us Facebook - https://www.facebook.com/AgingUS/ Twitter - https://twitter.com/AgingJrnl Instagram - https://www.instagram.com/agingjrnl/ YouTube - https://www.youtube.com/agingus​ LinkedIn - https://www.linkedin.com/company/aging/ Pinterest - https://www.pinterest.com/AgingUS/ Media Contact 18009220957 MEDIA@IMPACTJOURNALS.COM

Current DHF Board President Kim Holley discusses the present and future of DHF. discipleheritage.org

Som ligatræner i Randers HK skal Ole Bitsch sikre overlevelse og hente alle de points i ligaen, som han og holdet kan. Som ny ungdomslandstræner skal han udvikle fremtidens landsholdsspillere. For Ole Bitsch handler begge dele om et klart og anerkendende lederskab. Og om det han gerne vil stå for som menneske. For Ole Bitsch handler det om ledelse. Om at skabe klare rammer for trivsel og udvikling. Han skal nu afsted på den første store samling med 06 og 07-årgangen. En generation af digitale indfødte, der skal præstere i mange arenaer, og som Ole Bitsch har fire år til at følge i DHF-systemet. Vi mødte ham i Randers. Til en samtale om talenter, ligaen, Generation Y, ledelse, ønsker til et fremtidigt licenssystem og meget, meget mere. Gæst: Ole Bitsch Vært: Thomas Ladegaard *Udsendelsen er sponsoreret af Sparekassen Kronjylland*

In this episode, we interview Dr. Doug Harvey, one of the three co-founders of DHF. We survey the beginnings of DHF to better understand the ministry to which God has called us. If you are new to DHF, or just want a refresher, this is for you!

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.

For many new medical device professionals a bill of materials (BOM) may feel like a big black box. Who owns it? How does it function within a QMS? How is it used differently in design versus in manufacturing?In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols learn the answers to these common questions, and more, about a medical device bill of materials from guest Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box.Mark has more than 30 years of experience in the medical device industry and takes organizations to the next level of quality system, product development, and operational excellence. His vision, experience, and hands-on leadership drive best practices in quality system processes and project management.Some of the highlights of this episode include:The FDA and ISO quality system requirements include design controls, which have a direct correlation to BOMs.The Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) are parts associated with design controls. Mark explains the difference between the three to build a product.For BOMs, there needs to be one source of the truth and everything else needs to match it. A master document needs to be defined, then other files and records copy and configure the same data.Based on configuration management, BOMs should include several components, such as a unique identifier/part number, description of part, quantity, unit of measure, operations step, assemblies, and reference designators.When building a BOM, define attributes or metadata that accommodate manufacturing and design points of view to avoid confusion.Design a flexible system. If you design for flexibility, then you'll never have to worry about changing your quality system because it can't handle a new product.Determine the rules of interchangeability. As products change, remember to change the part number and update the version on the BOM.Who owns the BOM? The medical device manufacturer owns the BOM because they are the approver and own the DMR and DHF.Memorable quotes from Mark Rutkiewicz:“The Bill of Materials, you can also grow it to be a Bill of Documents and a Bill of Operations. All that is sort of what's required to build a product.”“That's why there's multiple documents today. The manufacturing people want to see it this way. The design people want to see it this way. They're not talking to each other.” “If you design for flexibility, then you're never going to have to worry about, ‘Oh, I ve got to change my quality system because I got this new product because my quality system can't handle it.'” “Every digit in the part number means something.” Links:FDA - Quality System (QS) RegulationISO - Quality Management Systems RequirementMark Rutkiewicz on LinkedInMark Rutkiewicz on TwitterInnovizeConsiliso LLCMedical Device Company In A Box: The Case For ConsilisoBill of Materials (BOMs)Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the difference?Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Den 19. marts lancerede Dansk Håndbold Forbund et videns- og holdningsgrundlag for børne- og ungdomshåndbolden i Danmark ved navn ”Rigtig, sjov håndbold”. ”Rigtig, sjov håndbold” indeholder en række forskningsresultater og udsagn fra en række forske-re og praktikere. Vi har talt med DHF's formand Morten Stig Christensen om, hvad håndbolden kan få ud af at samarbejde med forskningsverdenen. Hør om hele baggrunden for ”Rigtig, sjov håndbold” her. Og følg med i de kommende uger, når vi her på Mediano Håndbold udgiver en række samtaler med nogle af de folk, der har bidraget til ”Rigtig, sjov håndbold”. Gæst: Morten Stig Christensen, formand DHF Vært: Thomas Ladegaard

DHF or Design History File or DMR or DHR or … What does all this mean? We will focus on DHF but we'll also provide an explanation of the other acronyms. In this episode of the Podcast, Alexandros Savvidis will share with us his experience. He'll provide some examples. So don't hesitate to check this episode if you are willing to get more understanding and ask your questions in the comments. Who is Alexandros Savvidis? Alexandros Savvidis is a Senior Medical Device Specialist active more than 17 years in multiple areas including Regulatory Affairs, Quality Management, R&D, Sales, Technical Support & Analysis. After his studies in Biomedical Engineering, he has worked in the medical devices as also the pharma packaging industry across Europe in Germany, Switzerland, Netherlands, UK, and Greece. He has organized and contributed as an RA Specialist to various successful international certifications of medical devices of all classes. Alexandros has gained one overall experience and deep understanding through his various roles on the full norm compliant development and certification process, like many other aspects like GMP, quality, risk management, vigilance, or clinical evaluations. He has worked on small, middle-size companies alone or a team member, or even on cross-functional teams of Life Science Giants. In the last years is his main focus is the implementation of MDR requirements and updates 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 and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links Alexandros Linkedin Profile: https://www.linkedin.com/in/alexandrossavvidis/ What is a DHF?: https://www.greenlight.guru/glossary/design-history-file

Hunter Keegan revisits and commentates on Part 2 of the original DHF miniseries about Casey and Caylee Anthony. This part of the series explores the circumstances around the discovery of Caylee Anthony's skeletal remains and the developments in the tragic saga thereafter. Follow Hunter Keegan on Twitter @HHKeegan www.hhkeegan.com

In June 2008, a 2-year-old girl named Caylee Anthony mysteriously vanished from Orlando, Florida. After it was discovered that her mother, Casey Anthony, had waited 31 days to report her missing the story garnered national attention almost overnight. Caylee's disappearance sparked intrigue and outrage and Casey Anthony became the most infamous woman in America. In Episode 37 of DHF, Hunter Keegan revisits Part 1 of his 2017 miniseries about Casey Anthony. This episode is an abridged version of the one that originally aired with additional commentary. Twitter @HHKeegan Web: hhkeegan.com

In de eerste editie wordt dengue (knokkelkoorts) besproken. Door de wereldwijde toename van Dengue neemt de kans toe dat reizigers terugkomen met een dengue virusinfectie. Ook zien we door de klimaatveranderingen een toename van dengue in Europa, dus ook in Nederland. Mensen kunnen meerdere malen dengue krijgen. Een klein deel van de infecties ontwikkelt tot ernstige dengue met complicaties zoals dengue hemorragische koorts (DHF) en dengue shock syndroom (DSS). Zonder behandeling zijn dergelijke complicaties levensbedreigend. Zaken die Joop, Eric en Bob o.a bespreken zijn: Hoe wordt het virus overgedragen? Hoe is het ziekteverloop? Wat kan je doen om jezelf te beschermen? Is er een vaccine beschikbaar?

Før EM-kvalifikationskampen mellem Danmark og Østrig den 7. oktober talte vores redaktør Thomas Ladegaard med DHF-formand Morten Stig Christensen om håndboldens fremtid. Det skete foran et medlevende publikum inviteret af Sparekassen Kronjylland. Vi har fået en lydoptagelse fra samtalen, som vi bringer her. Det er en optagelse fra rummet, så der er publikum og tallerkener. Men der er også gode pointer og overvejelser fra DHF-formand Morten Stig Christensen om den fremtid, han ser for dansk håndbold. Medvirkede: Morten Stig Christensen, Thomas Ladegaard og et medlevende publikum Udsendelsen er sponsoreret af Sparekassen Kronjylland

Dette afsnit er lavet i samarbejde med Hellofresh måltidskasser og Faxe Kondi.  Brug koden MADDUFT eller benyt følgende link få at få op mod 725 kr i rabat på Hellofresh Nikolaj Jacobsen har forlænget med DHF frem til 2025. I dette afsnit skal vi kigge frem på det landshold, vi har i vente de kommende fire år. Men vi skal også kigge tilbage til 2017, hvor Nikolaj overtager et landshold, som måske er lidt flosset i de mentale kanter. Hvilket landshold overtog han dengang og hvordan satte han sit præg rent taktisk? Til VM i vinter viste holdet nye sider af sig selv med nye spillertyper, så hvor står holdet i dag? Til slut skal vi se frem i tiden. Hvad skal der ske de næste fire år, hvilke spillere er på vej frem og hvor skal holdet hen? Husk at du også kan hjælpe HAND ved tilmelde dit hold til https://boedekassen.dk/ Duften af Harpiks tee fra Hummel er på vej! Skriv meget gerne en anmeldelse af podcasten og giv stjerner her: https://podcasts.apple.com/dk/podcast/duften-af-harpiks/id1482597703 Følg os på Facebook https://www.facebook.com/duftenafharpiks/ eller på Instagram https://www.instagram.com/duftenafharpiks_niklas_landin/ hvor du kan få endnu mere indsigt og deltage i give aways! Kontakt: radioteket@radioteket.dk Musik af Jacob Horney og Jonas Landin    

I weekenden missede den danske badmintonstjerne Viktor Axelsen EM-finalen på grund af en positiv corona-test. De danske håndboldherrer og resten af vores OL-atleter risikerer det samme, når de skal kæmpe for medaljer til Danmark i Japan til sommer. Skal stjernerne foran i vaccinekøen? Nej, siger regeringen - de må vente som alle andre. Er det spild af hårdt arbejde, mange penge og medaljehåb? Er det småligt eller retfærdigt? Og er der aldrig nogen, der bare er vigtigere end andre? I P1 Debat kæmper politikere og sportens folk på ord og holdninger: Hør Kasper Sand Kjær (S), Jan E. Jørgensen (V), Kim Astrup, professionel badmintonspiller, B.S. Christiansen, mentaltræner og tidligere elitesoldat, Torben Hollmann, FOA, og Morten Henriksen, sportschef DHF. Vært: Marie Louise Toksvig. Lytterne er velkomne til at komme med indspark til debatten på telefon 7021 1919. www.dr.dk/p1debat

I weekenden missede den danske badmintonstjerne Viktor Axelsen EM-finalen på grund af en positiv corona-test. De danske håndboldherrer og resten af vores OL-atleter risikerer det samme, når de skal kæmpe for medaljer til Danmark i Japan til sommer. Skal stjernerne foran i vaccinekøen? Nej, siger regeringen - de må vente som alle andre. Er det spild af hårdt arbejde, mange penge og medaljehåb? Er det småligt eller retfærdigt? Og er der aldrig nogen, der bare er vigtigere end andre? I P1 Debat kæmper politikere og sportens folk på ord og holdninger: Hør Kasper Sand Kjær (S), Jan E. Jørgensen (V), Kim Astrup, professionel badmintonspiller, B.S. Christiansen, mentaltræner og tidligere elitesoldat, Torben Hollmann, FOA, og Morten Henriksen, sportschef DHF. Vært: Marie Louise Toksvig. Lytterne er velkomne til at komme med indspark til debatten på telefon 7021 1919. www.dr.dk/p1debat

I weekenden missede den danske badmintonstjerne Viktor Axelsen EM-finalen på grund af en positiv corona-test. De danske håndboldherrer og resten af vores OL-atleter risikerer det samme, når de skal kæmpe for medaljer til Danmark i Japan til sommer. Skal stjernerne foran i vaccinekøen? Nej, siger regeringen - de må vente som alle andre. Er det spild af hårdt arbejde, mange penge og medaljehåb? Er det småligt eller retfærdigt? Og er der aldrig nogen, der bare er vigtigere end andre? I P1 Debat kæmper politikere og sportens folk på ord og holdninger: Hør Kasper Sand Kjær (S), Jan E. Jørgensen (V), Kim Astrup, professionel badmintonspiller, B.S. Christiansen, mentaltræner og tidligere elitesoldat, Torben Hollmann, FOA, og Morten Henriksen, sportschef DHF. Vært: Marie Louise Toksvig. Lytterne er velkomne til at komme med indspark til debatten på telefon 7021 1919. www.dr.dk/p1debat

Han har været en del af det danske landshold i femten år. Så længe at det måske efterhånden er blevet til “Kajs hold”. Kaj Johannsen er som herrelandsholdets holdleder det faste holdepunkt fra slutrunde til slutrunde og fra samling til samling. Vi har mødt ham til en samtale om rollen som holdleder - og om de store oplevelser med det danske herrelandshold. Tæt på den dansk-tyske grænse i Kollund har Kaj Johannsen sin faste base. Men på herrelandsholdet er det ham, der er den faste base for både spillere og trænere. Som holdleder har han været med siden 2006. Og siden 2013 har han tillige arbejdet som elitevejleder i DHF. Vi mødte Kaj Johannsen til en samtale om rollen som holdleder for de danske herrer. Om store oplevelser, fællesskabet og alt det, der gør det værd at være en del af det danske herrelandshold. Gæster: Kaj Johannsen og Henrik Kronborg Vært: Thomas Ladegaard *Udsendelsen er sponsoreret af Sparekassen Kronjylland*

Matt is a former United States Marine serving from 2006-2011 and doing 3 tours overseas. After Matt got out, he started going to college at the University of Utah. Six years and another deployment to Afghanistan later he was able to earn a bachelor’s degree in Kinesiology. On top of having his bachelor’s degree, Matt is also a Certified Strength and Conditioning Specialist (CSCS) from the National Strength and Conditioning Association (NSCA). Matt comes to us after owning and operating his own gym for 5 years. He loves helping people become healthier and happier and is here to serve all your fitness needs as he works out of our Salt Lake City location as part of our DHF team.Contact MattOffice: 801-515-7256Email: mjudy@primeinc.comLearn more about the Prime Inc. Driver Health & Fitness Program in these places:Website: https://driverhealthandfitness.com/Instagram: @primefitfleetFacebook Group: Prime Driver Health & Fitness (https://www.facebook.com/groups/407841039845829/)Email for more info: dhf@primeinc.com Phone: 417-866-0001

Tonight is the night! In honor of our sport’s 50th anniversary in the United States, DHF, along with Scott Duggan, present the first of a five part series full of stories told by the people who helped build the game we all love. Tonight's release features Chris Housser as he outlines the origins.

Go' Morgen P3 har sendt praktikant Signe Kronholm til Bornholm for at tjekke op på stemningen på Danmarks yndlingsø! Samtidig tager vi et kig på Israels coronasituation. Der er kæmpe eufori i Egypten, hvor Morten Henriksen, sportchef for DHF, er live med, og vi kan godt love, at stemningen er høj i Cairo! Derudover er der skriftlige fuck-ups, i dagens anledning en facerape udgave!

Hunter Keegan explores one of the darkest stories covered on DHF so far: The senseless murder of an aspiring school teacher. Warning: This episode contains disturbing content. Website: hhkeegan.com Facebook Group: Down Home Fear Podcast Twitter: @hhkeegan + @downhomefear

The road to a pain free life starts now! Sign up today for the NEW Functional Freedom Program through Driver Health and Fitness. This program starts on October 12th and runs until November 20th. All Prime Inc. Drivers that finish the program and complete the pre- and post-program surveys will be entered into a drawing for 1 of 3 $100 gift cards. How to Get Started:✔️ Sign-up on driverhealthandfitness.com under the "Programs" tab or use this link: https://driverhealthandfitness.com/programs/. ✔️ Fill out pre-program survey before program starts. What to Expect during the 6-week Functional Freedom Program:✔️ Follow along with the exercise videos on the Functional Freedom section of the website. All routines are in-truck friendly, last from 4-10 minutes, and there are 5 videos released each week.✔️ Consult with your movement coach and DHF Coordinator frequently via phone (417)-521-3473 or through messaging to DHF through the Prime Mobile App.✔️ Submit program questions to DHF through the Prime Mobile app that we will answer in a weekly Q&A video which will be posted to our website and Facebook accountability page.✔️ Join our accountability group on Facebook called "DHF Functional Freedom Accountability" (Link to group: https://www.facebook.com/groups/331676781400336 ). ✔️ Fill out the post-program survey.The Functional Freedom Program costs drivers $0/day! This program is a free benefit offered exclusively through Prime Inc.National average cost for most popular back pain treatments:Chiropractor appointment: $65Physical therapy sessions: $50-$125Cost of back pain per year on average: $6,096A Note from Matt Hancock (Functional Freedom Program creator, Certified Exercise Physiologist, and Driver Health and Fitness Coordinator): “I've been a victim of back pain for years. I was diagnosed with a hip impingement 5 years ago and was tossed around in the healthcare system in a cycle of physical therapy, MRI’s, doctor appointments, and muscle relaxers. I got no relief. I didn't know where to turn. I finally decided to take matters into my own hands and researched movements that would help me get out of pain for good. All of these movements are things that helped me get out of pain and move freely again. Backed by science, research, and best practices in physical therapy settings, I know they can help you too.”Want to see a professional chiropractor for your back issues, too? If you are a Prime driving or non-driving associate or immediate family member, you can sign up for an appointment with our Chiropractor onsite at Prime Inc here: https://www.chiroatprime.com/appointments. You will pay a flat discounted rate of $35/visit. No insurance needed!Learn more about the Prime Inc. Driver Health & Fitness Program in these places:Website: https://driverhealthandfitness.com/Instagram: @primefitfleetFacebook Group: Prime Driver Health & Fitness (https://www.facebook.com/groups/407841039845829/)Email for more info: dhf@primeinc.com Phone: 417-866-0001

La valenciana Sara Bravo es protagonista en el podcast en Tiempo en Femenino de Plaza Radio tras ganar la Copa de la Reina de balonmano. Todavía con la resaca de la celebración de la Copa de la Reina 2020, medida en todo caso a causa de la crisis sanitaria de la Covid-19, Bravo, que logró la corona con el Rincón Fertilidad Málaga en la final ante el CBM Elche, repasa los mejores momentos del torneo y hace balance del recorrido en tiempos del coronavirus hasta la vuelta a la competición. De hecho, ya se retoma la Liga Guerreras Iberdrola y una temporada en la que la valenciana compite con Málaga en la DHF, la siguiente Copa y el torneo europeo.Sara Bravo repasa también su recorrido, desde sus inicios en Mislata, paso a paso, sabiendo lo que es el sufrimiento por mantener la categoría y los ascensos, aprendiendo de las experiencias con el antiguo Marítim luego Canyamelar Valencia, y encontrando la oportunidad del salto hacia pujar por los títulos como fue el caso del Atlético Guardés o el Rincón Fertilidad Málaga.El podcast Sara Bravo: De la corona de Copa de la Reina y los orígenes en el balonmano en Mislata ha sido publicado en Plaza Radio

Skader i håndbold er desværre et evigt aktuelt område, og arbejdet med at forebygge de alvorlige skader er et forskningsområde under stor udvikling. Jesper Bencke er en af de fremmeste forskere på området og en del af DHF's ekspertgruppe, der har været været med til at udvikle den nye Performanceprofil og anbefalingerne for ”Den gode opstart” efter Corona. I denne udsendelse fortæller Jesper Bencke om skaderne i håndbold. Og om hvordan man kan arbejde med forebyggelse af skader - særligt i skulderen og i korsbåndet. Et område, der som der forskes intensivt i. Men som måske ikke er det, der er højest på agendaen i en hverdag, hvor der også skal trænes fysisk, taktisk, teknisk og mentalt. For Jesper Bencke hænger de ting sammen. Og i udsendelsen giver han gode råd til, hvordan man kan indpasse den skadeforebyggende træning i den almindelige træning. Gæst: Jesper Bencke Vært: Thomas Ladegaard *Udsendelsen er sponsoreret af Sparekassen Kronjylland*

Another NDA 3on3 Natty is in the books and of course it did not disappoint. DHF regroups for a weekend wrap.