Podcasts about cfr part

Mariano Mattei is the Vice President of Cybersecurity and AI at Azzur Solutions, bringing over 30 years of expertise in cybersecurity, AI innovation, and software engineering. A Certified Chief Information Security Officer (CCISO), Mariano has led AI-driven transformations across Biotechnology, Pharmaceuticals, and Medical Device sectors, integrating AI into clinical trials, manufacturing automation, quality systems, and regulatory compliance frameworks (FDA 21 CFR Part 11, GAMP 5, GDPR, HIPAA). His work spans predictive analytics for risk management, AI-powered process optimization, anomaly detection in manufacturing, and regulatory AI governance. He recently graduated from Temple University's Master's Program in Cyber Defense and Information Assurance, and he's the author of "Data-Driven Cybersecurity – Proven Metrics for Reducing Cyber Risk"Listen NOW to discover, "The Secret to Taking A Secure Risk"

Are you new to the medical device industry—or mentoring someone who is? In this foundational episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Sara Adams and Chris Rush from Greenlight Guru to deliver a MedTech 101 masterclass. They unpack the roles, regulations, and realities of medical device development in a heavily regulated space. From defining what actually counts as a medical device to navigating FDA classifications and global regulations, the trio offers practical insights, industry analogies, and personal war stories that make this episode as entertaining as it is educational. Whether you're in R&D, marketing, clinical, or quality, this is the episode to bookmark and share with every new hire.Key Timestamps02:20 – What counts as a medical device? Intended use and labeling06:48 – Differentiating roles: Quality, Regulatory, Clinical, R&D, and Marketing15:40 – Understanding regulatory bodies: FDA, EU MDR, Health Canada, and more20:15 – FDA Classifications: Class I, II, III, and what determines risk26:00 – Standards to know: ISO 13485, 14971, 14155, 21 CFR Part 82033:05 – FDA pathways: 510(k), De Novo, PMA – when and why they apply41:55 – The design control matrix explained (User Needs through Validation)49:00 – Reverse engineering design controls: pitfalls and best practices55:30 – Clinical trials vs. preclinical studies: When each is required1:00:45 – Manufacturing & supplier controls: operations meets compliance1:04:15 – Final advice for MedTech newcomers: Read the regs and know the problemQuotes“Just because you don't call it a medical device doesn't mean the FDA agrees with you.” – Sarah AdamsThis quote highlights a key regulatory pitfall: your marketing claims, not just your label, determine if the FDA considers your product a medical device.“A 510(k) is like someone checking your wristband at the door—you're cleared to go in. A PMA? That's a locked door and you need full approval to enter.” – Chris RushA memorable analogy that demystifies the difference between FDA clearance and approval pathways.Top TakeawaysLabeling + Intended Use = Regulatory TriggerWhether it's software or a simple tool, if your product makes medical claims or supports medical decision-making, it may fall under FDA or other international regulatory oversight.Regulatory Pathways Are Tied to Risk and NoveltyKnow the difference between a 510(k), De Novo, and PMA. Class II “me-too” devices may avoid clinical trials, while Class III and novel devices usually require significant evidence.Understand Design Controls EarlyReverse-engineering documentation late in development is risky and inefficient. Start early with user needs and build forward through the five pillars: inputs, outputs, verification, and validation.Cross-functional Understanding Prevents Compliance GapsMarketing, clinical, and R&D all influence regulatory standing. Even social media likes can trigger off-label scrutiny—every department needs to understand their regulatory impact.Reading Regulations Is Not OptionalA strong regulatory foundation is key to faster development, better audits, and smoother market access. Resources like 21 CFR Part 820 and ISO 13485 are surprisingly readable and essential.References & ResourcesEtienne Nichols on LinkedInChris Rush on LinkedIn

In October 2024, the latest changes to the Office of Management and Budget's (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (also known as 2 CFR Part 200 or Uniform Guidance) went into effect. Many changes were beneficial to grantees. And while this was recorded before the new administration started making drastic changes in the federal funding landscape, the Uniform Guidance as it stands is in effect until updated again.   JOIN THE FUNDRAISING HAYDAY COMMUNITY: Become a member of the Patreon   SHOW NOTES: Code of Federal Regulations Part 200 (2 CFR Part 200) – Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards – Where to find the most current version (and you should always go with source material over what is aired in a podcast!) - eCFR :: 2 CFR Part 200 -- Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards   Update guidance of federal funders, and material used by Fundraising HayDay to help create this episode: Housing and Urban Development - https://hudgov-my.sharepoint.com/personal/daniel_s_celaya_hud_gov/Documents/2 CFR 200 Changes 2020 vs 2024 breakdown Environmental Protection Agency - What's New in the Uniform Grants Guidance 2024 Revision to 2 CFR 200 | US EPA Department of Justice, Office of Justice Programs - 2024 Part 200 Uniform Requirements Updates   OMB memorandum M-10-11 “Guidance on the Use of Challenges and Prizes to Promote Open Government” issued March 8, 2010 - Memoranda   To learn more about federal grant management, consider registering for the Grant Professionals Associations Next Level Grant University course on grant management - Next Level Grant Training - Grant Professionals Association

In this episode of the Quality Hub: Chatting with ISO Experts, host Xavier Francis discusses ISO 9001 vs other Quality Management Systems - What's the Difference (Part 1) with Suzanne Weber-Smatko and Murphy Shaw from Core Business Solutions. They explore ISO 9001's role in standardizing processes for consistency and improvement, comparing it to industry-specific standards like ISO 13485 for medical devices, AS 9100 for aerospace, and 21 CFR Part 820, an FDA regulation. The discussion also covers Six Sigma, a data-driven methodology for reducing defects, highlighting its individual certification structure versus ISO 9001's organizational certification. The episode emphasizes how businesses can integrate multiple quality systems for better efficiency and compliance, setting the stage for Part 2.   Helpful Resources:   What is a Mature QMS?:  https://www.thecoresolution.com/quality-management-system-maturity Compliance vs. Certification:  https://www.thecoresolution.com/iso-compliance-vs-certification For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015 Contact us at 866.354.0300 or email us at info@thecoresolution.com A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting  

This podcast episode is part of a series focused on the critical issue of the opioid epidemic, and how healthcare IT and health information exchanges (HIEs) can bridge interoperability gaps. Explore how HealtheConnections is enhancing data exchange and interoperability to tackle opioid treatment and prevention. The podcast provides a look into the innovative use of emerging technologies, addresses regulatory impacts, and highlights the role of community data in reshaping behavioral healthcare.Things You'll Learn:The vital role of HIEs in Central New York's healthcare ecosystem. Key technologies used by HealtheConnections for supporting interoperability and opioid treatment programs. Emerging trends and technologies expected to impact the interoperability landscape in the next 3-5 years. How regulatory changes to 42 CFR Part 2 are affecting HIEs and their stakeholders. Methods used by HealtheConnections to support local health departments in monitoring and reporting opioid overdoses. Real-world examples of innovative processes enhancing overdose tracking and prevention. The impact of community data on person-centered care in behavioral healthcare. How HL7v2 feeds and other technologies are improving interoperability at Helio Health. MODERATOR: Bill Cioffi MPPA, CHCIO, ITILClient Partnership Executive, Nordic Healthcare Bill is a seasoned healthcare IT executive and the Client Partnership Executive at Nordic Healthcare, where he focuses on strengthening client relationships, expanding portfolios, and driving strategic growth. With over 15 years of experience in healthcare IT leadership and 25+ years in IT infrastructure and operations, he has a proven track record of leading digital transformation initiatives.GUEST: Elizabeth AmatoPresident and CEO, HealtheConnections A 16-year veteran of the health IT field, with focused expertise in program development and design, advocacy, research, and source funding. For the past 12 years, she has held various leadership positions in the New York state HIE space, including the past 3 years serving as the Chief Operating Officer at NY's second largest HIE, HealtheConnections. As of January 1st she assumed the role of President & CEO at HealtheConnections. Elizabeth is a passionate advocate for improving the health of communities through HIE, data-centric technology, and clinical-community partnerships. GUEST: Liana ProsonicAssociate VP, Finance and Compliance Liana is a certified public accountant (CPA) and worked for 8 years in public accounting before transitioning to management accounting in 2016. They worked as Director of Accounting Operations at Loretto, a long-term post-acute care provider, for 5 years, and moved into a new role as Director of Finance and Compliance at HealtheConnnections, a HIE, in 2021. In their current role as AVP of Finance and Compliance at HealtheConnections they oversee the financial operations and compliance program. They also teach accounting as an adjunct professor at York College of Pennsylvania. GUEST: Corey ZeiglerCIO, Helio Health Corey has been with Helio Health for about 5 years. They are a large substance use and behavioral health organization with 70 different locations throughout Central New York spanning from Albany in the eastern side to Rochester on the western side, down to the Pennsylvania border to the south and almost to Canada in the North. Their services include inpatient, outpatient, residential, affordable housing, homelessness and a lot of the health and human services functions in New York State.The CHIME Opioid Task Force (OTF) was launched in early 2018 with a simple mission: to turn the tide on the opioid epidemic using the knowledge and expertise of the nation's healthcare IT leaders. While our mission is simple, achieving it is not. Opioid addictin is a complex disease that requires long-term, if not lifetime, care from well-informed clinicians who are supported with easy-to-use and reliable tools.

Welcome solo and group practice owners! We are Liath Dalton and Evan Dumas, your co-hosts of Group Practice Tech. In our latest episode, we share an overview of the big stories, developments, and regulatory changes that will impact group practices in 2025. We discuss: A proposed change to the HIPAA Security Rule, and how it will impact group practices OCR resuming their HIPAA Compliance Audit program Updates on telehealth provisions and exceptions for Medicare and important dates to know Updates on the Counseling Compact and the Social Work Licensure Compact Upcoming regulatory changes for AI use and our current recommendations Listen here: https://personcenteredtech.com/group/podcast/ For more, visit our website. Resources: Proposed New Rule From HHS: HIPAA Security Rule Notice of Proposed Rulemaking to Strengthen Cybersecurity for Electronic Protected Health Information Resumption of OCR's (the HIPAA Regulators) HIPAA Audit Program New Rule: HIPAA Privacy Rule Final Rule to Support Reproductive Health Care Privacy: Fact Sheet Model Attestation for a Requested Use or Disclosure of Protected Health Information Potentially Related to Reproductive Health Care New Rule: Fact Sheet 42 CFR Part 2 Final Rule Telehealth Update: DEA/HHS Temporary Rule, Medicare Coverage of Telehealth Services, and What to Watch For in 2025 Medicare Telehealth Flexibilities Get a Three-Month Lifeline JPM2025: Regulation of artificial intelligence: Navigating a new frontier in health care | JD Supra   PCT Resources: Relevant on-demand, legal-ethical CE training: Law & Ethics of Clinical Documentation for a post Roe world Addresses the practical applications of the US Supreme Court's ruling in Dobbs v. Jackson Women's Health Organization, with particular focus on the impacts this decision has on client confidentiality and documentation of clinical services Relevant on-demand, legal-ethical CE training: The Evolving Legal-Ethical Standard of Care for the Clinical Use of Artificial Intelligence in Mental Health Gain insights into the benefits and challenges of incorporating AI technologies into their practice, understand the clinical implications, and learn how to navigate legal and ethical guidelines while maintaining compliance with HIPAA regulations. PCT's Comprehensive HIPAA Security Compliance Program (discounted) bundles: For Group Practices For Solo Practitioners PCT's HIPAA Risk Analysis & Risk Mitigation Planning service for mental health group practices -- care for your practice using our supportive, shame-free risk analysis and mitigation planning service. You'll have your Risk Analysis done within 2 hours, performed by a PCT consultant, using a tool built specifically for mental health group practice, and a mitigation checklist to help you reduce your risks. Group Practice Care Premium weekly (live & recorded) direct support & consultation service, Group Practice Office Hours -- including monthly session with therapist attorney Eric Ström, JD PhD LMHC + assignable staff HIPAA Security Awareness: Bring Your Own Device training + access to Device Security Center with step-by-step device-specific tutorials & registration forms for securing and documenting all personally owned & practice-provided devices (for *all* team members at no per-person cost) + assignable staff HIPAA Security Awareness: Remote Workspaces training for all team members + access to Remote Workspace Center with step-by-step tutorials & registration forms for securing and documenting Remote Workspaces (for *all* team members at no per-person cost) + more

Well, it happened. We talk about what the election of Donald Trump means for you, for the country, for this show, and for the efforts to hold Trump accountable for his crimes against the American people. Special Counsel Jack Smith has announced that he intends to “wrap up” his office; we tell you why and what that means. We'll be here with you, and we'll always tell you the truth.   Links:   NPR report: Smith To Wind Down https://www.npr.org/2024/11/06/g-s1-33021/trump-trials-jack-smith-election-2024   28 CFR Part 600 (Special Counsel regulations) https://www.law.cornell.edu/cfr/text/28/part-600   Trump v. US (2024) https://www.law.cornell.edu/supct/pdf/23-939.pdf   24 Op. OLC 222 (2000) - Presidential immunity https://www.justice.gov/file/146241-0/dl?inline Show Links: https://www.lawandchaospod.com/ BlueSky: @LawAndChaosPod Threads: @LawAndChaosPod Twitter: @LawAndChaosPod Patreon: patreon.com/LawAndChaosPod  

Toggle ModeNational Advisory Committee on Microbiological Criteria for Foods - WikipediaUnited States Department of Agriculture South Building - WikipediaJamie L. Whitten Building - WikipediaDamn, Poisoned won the Emmy | Marler BlogFood Safety Talk 282: The Fabulous Ms. Mertzel — Food Safety TalkGovernor Cooper Declares State of Emergency Ahead of Hurricane Helene | NC Gov. CooperFront Matter | The Potential Consequences of Public Release of Food Safety and Inspection Service Establishment-Specific Data | The National Academies PressConference for Food ProtectionHome - Cards Against HumanityAbout - Cards Against HumanityDiet Mountain Dew - WikipediaFood Safety Talk 185: Hot Diapers — Food Safety TalkLudwig (TV series) - WikipediaMaggie Smith, star of stage, film and ‘Downton Abbey,' dies at 89 | AP NewsWatch the Football! ⚽ | That Mitchell and Webb Look - BBC - YouTubeKatie Swanson | LinkedInEvaluation and Definition of Potentially Hazardous Foods2023-2025 National Advisory Committee on Microbiological Criteria for Foods (NACMCF) | Food Safety and Inspection ServiceMerlin Mann - Who moved my brain? - YouTubeMicrobiological survey and genomic analysis of Cronobacter sakazakii strains isolated from US households and retail foods | Applied and Environmental MicrobiologyChallenges in Supply, Market Competition, and Regulation of Infant Formula in the United States | The National Academies PresseCFR :: 21 CFR Part 107 Subpart B – LabelingListeria outbreak: Boar's Head closing Virginia plant | AP NewsMicrobiological quality of flour products in the UK with respect to Salmonella and Shiga-toxin-producing Escherichia coli | Journal of Applied Microbiology | Oxford AcademicHow To Make Liverwurst - Step-By-Step Guide & 5 RecipesUS2860992A - Process of manufacturing liver sausage - Google PatentsLiverwurst 101Deviled Ham Spread - Underwood SpreadsSalmonella Outbreak Linked to Eggs | CDCOutbreak Investigation of Salmonella: Eggs (Sept 2024) | FDANorth Carolina salmonella outbreak leads to largest egg recall in nearly a decadeSalmonella outbreak: Egg farm had rodent infestation, FDA says - The Washington PostDecoding the Gurus

Series on "Mysteries & Medicine" by Fr. Isaiah, CFR (Part 4) Are you able to see the goodness of God? We are invited to trust and surrender that God is good and is always with us, to be rooted in the truth that God is Father, that He knows us, that He is good, and that He loves us. This is the fourth and last episode on the Mysteries & Medicine album which teaches us how we can call out to Him and ask for the grace to trust Him and to be reunited in our identity, but most importantly, first and foremost, His identity—a deeper dive into our life journey, our pilgrimage with the one who is always with us, loves us and knows us by name. You can get a physical CD copy of Mysteries & Medicine and the prayer journal at https;//monkmanual.com/friars The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

Series on "Mysteries & Medicine" by Fr. Isaiah, CFR (Part 3) Have you experienced being confined in self-centeredness? Sometimes we can have a pretty self-focused approach to our lives where it's all about what we need or what we want.  But the invitation for us in this Exodus is to always move towards someone else, towards relationship, towards God—to be totally out of ourselves and make a self-gift back to God and to other people. This episode is the third part of our series on Fr. Isaiah's Mysteries & Medicine which talks about the nature of our desires and how we can transform them from being self-centered to being outer-centered. You can get a physical CD copy of Mysteries & Medicine and the prayer journal at https;//monkmanual.com/friars The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

Series on "Mysteries & Medicine" by Fr. Isaiah, CFR (Part 2) What do you desire and how do you respond to it? One reality of our humanity is that we can forever be dissatisfied and expect a different answer to our desires. But we are invited to let this desire, this hunger, become a pathway that brings the Lord closer to us, to offer Him the desire and just to be with Him in it. This episode is the second part of our series on Fr. Isaiah's Mysteries & Medicine which talks about our desires—the holy, the unmet, and the sinful desires and how we should respond to them. You can get a physical CD copy of Mysteries & Medicine and the prayer journal at https;//monkmanual.com/friars The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

Series on "Mysteries & Medicine" by Fr. Isaiah, CFR (Part 1) Would you agree that life is a journey or a pilgrimage? The journey to say yes to what God wants for our life, it's not just this thing that happens like a contract and we say, "Yes,", it's a journey. The holiness, the sanctification, the healing, it takes time.  The pilgrimage of life is tough, blindness, poverty and suffering are often a part of it, but Jesus is with us in this pilgrimage and he desires to not just walk along with us but to be the way that we walk to the Father's heart.  This episode is the first part of our series on Fr. Isaiah's Mysteries & Medicine, which talks about life as a pilgrimage, the experience of mystery, and the response of Jesus to this experience. You can get a physical CD copy of Mysteries & Medicine and the prayer journal at https;//monkmanual.com/friars The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

Today, Liz and Andrew talk to Salon's Amanda Marcotte about the right wing's assault on Title IX through the prism of the political wedge issue of women's sports. Then, Amanda breaks down the phenomenon of conservative “tradwives” as both cosplay and a gateway drug to white supremacy.   Links: “Texas professors sue to fail students who seek abortions,” by Amanda Marcotte https://www.salon.com/2024/06/03/texas-professors-to-fail-students-seek-abortions/   “After Supreme Court's abortion pill decision, Donald Trump is even more likely to ban abortion,” by Amanda Marcotte https://www.salon.com/2024/06/14/after-abortion-pill-decision-donald-is-even-more-likely-to-ban-abortion/   “A tradwife drops a racist slur: Why the right's trolling economy made Lilly Gaddis' rise inevitable,” by Amanda Marcotte https://www.salon.com/2024/06/17/a-tradwife-drops-a-slur-why-the-rights-trolling-economy-made-lilly-gaddis-rise-inevitable/   Bostock v. Clayton County https://www.supremecourt.gov/opinions/19pdf/17-1618_hfci.pdf   Title IX fact sheet https://www2.ed.gov/about/offices/list/ocr/docs/t9-final-rule-factsheet.pdf   34 CFR Part 106 (Final Rule - Title IX) https://www2.ed.gov/about/offices/list/ocr/docs/t9-unofficial-final-rule-2024.pdf   -Reed O'Connor “striking down” fact sheet https://storage.courtlistener.com/recap/gov.uscourts.txnd.377970/gov.uscourts.txnd.377970.37.0.pdf   TX v. USA (Judge Kacsmaryk Docket, via Court Listener) https://www.courtlistener.com/docket/68479793/state-of-texas-v-the-united-states-of-america/    TX v. Cardona (Judge O'Connor Docket, via Court Listener) https://www.courtlistener.com/docket/67502155/the-state-of-texas-v-cardona/    Show Links: https://www.lawandchaospod.com/ BlueSky: @LawAndChaosPod Threads: @LawAndChaosPod Twitter: @LawAndChaosPod Patreon: patreon.com/LawAndChaosPod  

Series on "The Father" by Fr. Mark-Mary Ames, CFR (Part 11) As a shepherd, what are you willing to lay down for your sheep? For shepherds nowadays, and even in the times of the Apostle, the sheep are for the shepherd's sake, they serve him. It's not like vice versa, sheep are the product and we get them to pasture so they can grow, so we can slaughter them.  But this wasn't the case for Jesus, He said that "I am the good shepherd "and I lay down my life for my sheep." Jesus loves us this way. He wants to be so close and hold us so intimately and he doesn't want us to be lost. He doesn't want us to be far away, but he wants to feed, protect, clothe, and hold us.  In this episode, as we bring our series on the book The Father to a close, we will be reflecting upon Jesus as the Good Shepherd and what this reveals to us of the heart of God as we talk about a story of a Father who freely lays down his life to save his son, and in doing so, loses his own life. The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

We update you on all of the states that have brought criminal charges against those involved in the “fake electors” plot to try and keep Donald Trump in the White House after he lost the 2020 election, including in particular the latest criminal complaint filed against Ken Chesbro in Wisconsin. In the B segment, we tell you how the Biden administration FINALLY banned asbestos. In 2024.   Links: Chesebro “The Real Deadline for Settling a State's Electoral Votes” memo https://app.box.com/s/ifis7hu74dz6xp0awkq567ygetrvcof1/file/1460145645094 AZ fake electors indictment https://www.azag.gov/sites/default/files/2024-05/PHX-%2312079639-v1-TRUE_BILL_-_INDICTMENT_93_SGJ_81.PDF GA indictment https://d3i6fh83elv35t.cloudfront.net/static/2023/08/CRIMINAL-INDICTMENT-Trump-Fulton-County-GA.pdf Georgia Court of Appeals, Stay of Roman v. State (AKA the Trump RICO case) https://s3.documentcloud.org/documents/24735877/stayproceedings.pdf  WI indictment https://s3.documentcloud.org/documents/24731470/24cf1293-24cf1294-24cf1295.pdf Corrosion Proof Fittings v. EPA https://law.justia.com/cases/federal/appellate-courts/F2/947/1201/153685/ ACC Letter to EPA re asbestos use http://src.bna.com/iuL Ural Asbest's Facebook page Trump insane asbestos tweet Link EPA's final rule on asbestos, 40 CFR Part 751 https://www.govinfo.gov/content/pkg/FR-2024-03-28/pdf/2024-05972.pdf EPA Factfinding pursuant to the TSCA https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-asbestos-part-1-chrysotile-asbestos   Show Links: https://www.lawandchaospod.com/ BlueSky: @LawAndChaosPod Threads: @LawAndChaosPod Twitter: @LawAndChaosPod Patreon: patreon.com/LawAndChaosPod  

Series on "The Father" by Fr. Mark-Mary Ames, CFR (Part 10) Can you imagine how it feels for a parent when their child dies? A father and a mother don't want to lose any of their children and this is an icon of understanding how God doesn't want any of his children to be lost—how passionate God is about our salvation. God desires none to be lost. Today we'll talk about how we can walk towards life and away from death as a fruit of sin. We'll dive deeper into how we can keep the life of grace and the heart of God fully alive in our souls. The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

Dive into cutting-edge aviation training with guest Sam Tomanio. Explore how harnessing data enhances simulation, the transformative impact of a specialized program, and the crucial documentation shaping a top-tier training experience. Join us for insights that elevate aviation expertise.   WHAT YOU'LL LEARN FROM THIS EPISODE Advanced Qualification Program: It's training process and what makes it different The impact of AQP in the aviation industry's training culture How data collected from simulations improves flight training Importance of a precise instructor evaluation program in aviation training Essential documentation for developing a high-caliber AQP   RESOURCES/LINKS MENTIONED Federal Aviation Administration  21.FIVE Podcast: Understanding AQP, the Next Generation of Airline Training   Read more about the AQP Program's gold standard at AC 120-54A - Advanced Qualification Program and 14 CFR Part 121 Training Program Review.   ABOUT SAM TOMANIO Sam is a retired airline pilot at American Airlines. As a freelance, Sam had an aviation technical writing gig that focused on aviation manual development, including training manuals, pilot handbooks and QRHs, AQP manuals, and curriculum development   CONNECT WITH SAM  Website: American Airlines LinkedIn: Sam Tomanio   CONNECT WITH US Are you ready to take your preparation to the next level? Don't wait until it's too late. Use the promo code “R4P” and save 10% on all our services. Check us out at www.spitfireelite.com!   If you want to recommend someone to guest on the show, email Nik at podcast@spitfireelite.com, and if you need a professional pilot resume, go to www.spitfireelite.com/podcast/ for FREE templates!   SPONSOR Are you a pilot just coming out of the military and looking for the perfect second home for your family? Look no further! Reach out to Marty and his team by visiting www.tridenthomeloans.com to get the best VA loans available anywhere in the US. If you're a professional pilot looking for a great financial planning partner for your retirement, tax, and investment, go to www.tpope.ceterainvestors.com/contact or call 704-717-9300 ext 120 to schedule a consultation appointment with Timothy P. Pope, CFP®. Be ready for takeoff anytime with 3D-stretch, stain-repellent, and wrinkle-free aviation uniforms by Flight Uniforms. Just go to www.flightuniform.com and type the code SPITFIREPOD20 to get a special 20% discount on your first order.

An important component of U.S. consumer protection law includes the regulation of endorsements, a form of advertising where someone other than the seller of a product or service—such as an athlete, a celebrity, or an influencer—is compensated to promote that product or service. In this episode, co-hosts Alicia Downey and Matt Reynolds talk to consumer protection lawyer Caiti Zeytoonian about the Federal Trade Commission's Guides Concerning the Use of Endorsements and Testimonials in Advertising, which were significantly updated in June 2023 to reflect the rising power and ubiquity of social media influencers. Listen and learn how the new guidance is making a difference in the rapidly evolving world of online endorsements. With special guest: Caiti Zeytoonian, Morgan, Lewis & Bockius LLP Related Links: 16 CFR Part 255, Guides Concerning Use of Endorsements and Testimonials in Advertising Disclosures 101 for Social Media Influencers The FTC Endorsement Guides: What People Are Asking (FAQs) Hosted by: Alicia Downey, Downey Law LLC and Matthew Reynolds, Huth Reynolds LLP

Series on "The Father" by Fr. Mark-Mary Ames, CFR (Part 8) What's your initial response to difficulty? Difficulty and suffering is something that's part of the world we live in and to move forward with the Lord we have to live in this reality, even though it's hard.  God is with us in it! One of the things a father also has to do is to teach their children and equip their children to do hard things. God the Father equips us and prepares us for what we need to have fulfillment and happiness in salvation, which includes learning how to carry and share in the suffering on the cross.  In this episode, we'll talk about how to persevere in doing hard things for an extended period of time and how to stay steady with the Lord amidst the difficulty. Here's the link to the graph that we referenced in the video: https://bit.ly/pocofreedomgraph The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

Series on "The Father" by Fr. Mark-Mary Ames, CFR (Part 7) What's the role that rules and laws play? Rules create boundaries and usually define the best way to do things. However, following rules can also NOT lead to freedom, this is why we need to learn to find the right balance in following the rules. In this episode, we will talk about the spirituality of laws and rules and how we can find balance to be safe, secure, and free in following them.  We are also invited to look at some of these rules that we have established, these etiquettes or cultures that we've put on ourselves, our neighbors, or our pastors.  Let's do some discernment of whether or not these are from God or not. And to also, go deeper and see what's at the heart of why we do that and ultimately, bring that to the Lord. Here's the link to the graph that we referenced in the video: https://bit.ly/pocofreedomgraph The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

Series on "The Father" by Fr. Mark-Mary Ames, CFR (Part 6) What does it mean to be safe? Safety is not the absence of suffering, it's not like we're not going to struggle with anything but it's the recognition that when we are vulnerable, we don't have to escape it, because someone wants to be with us and provide for us and that is our Lord, Jesus Christ. This is the safety that we are proposing. In this episode, we're focusing on the necessity of having sufficient resources and true expectations as we unpack what it really means to be truly safe. Here's the link to the graph that we referenced in the video: https://bit.ly/pocofreedomgraph The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

On today's episode, Zach hosts John Travis, principal at JFT PRG LLC. John shares his extensive background in healthcare and regulatory compliance and how Gen AI has fit in. They discuss the importance of transparency and fairness in AI applications, particularly in the healthcare decision-making processes.  John highlights the regulatory considerations for companies venturing into generative AI, emphasizing the need for understanding FDA and ONC guidelines. They touch on the complexities of data privacy laws like GDPR and HIPAA, and the challenges of ensuring data quality and representativeness in AI training datasets. The conversation underscores the evolving landscape of AI governance and the imperative for transparency in algorithmic decision-making. Like, Subscribe, and Follow: YouTube: https://www.youtube.com/channel/UCAIUNkXmnAPgLWnqUDpUGAQ LinkedIn: https://www.linkedin.com/company/keyhole-software Twitter: @KeyholeSoftware Find even more Keyhole content on our website (https://keyholesoftware.com/). About John: John Travis has a long history of helping companies meet healthcare regulations. He possesses particular expertise in HIPAA health information privacy, security and administrative simplification requirements, EHR/HIT Certification, CMS Revenue Cycle and Condition of Participation requirements, information blocking and interoperability requirements, 42 CFR Part 2 requirements for SUD treatment, 21 CFR Part 11 requirements among other regulatory requirements that impact the use of HIT. John is the founder of JFT PRG LLC, a company that provides consulting guidance for the intersection of health information technology and federal regulation. John on LinkedIn: https://www.linkedin.com/in/john-travis-716a495/ 

Liz and Andrew Torrez catch up with Trump's election lawyers. Where are they now, and why isn't it the hoosegow? Then a deep dive into the Biden administration's plan to reschedule marijuana. But first, Donald Trump has nothing but contempt for this court!   Links:   Trump Contempt Order https://www.nycourts.gov/LegacyPDFS/press/PDFs/D.O.motion4contempt-FINAL.pdf    Eastman Disciplinary Order https://discipline.calbar.ca.gov/portal/DocumentViewer/Index/UTKQ_Y63MDG4l4uhXSVCPqiU-at38jxNGUYub4sJpbGYEMPf_DmMRzCZgpvdUiQob9K9TKikC0XkAwVvafs3DPj9GHLcAlR9sE7K6hP1jE41?caseNum=SBC-23-O-30029&docType=Order%20/%20Ruling&docName=Ruling%20on%20Motion%20-%20Denied&docTypeId=13&isVersionId=False&p=0    Michigan appellate order on sanctions https://storage.courtlistener.com/recap/gov.uscourts.ca6.142572/gov.uscourts.ca6.142572.43.2.pdf   “Off the charts low” polling https://www.nbcnews.com/news/amp/rcna148170   Fair Labor Standards Act https://www.law.cornell.edu/uscode/text/29/chapter-8   DOL Final Rule, 29 CFR Part 541 https://www.dol.gov/sites/dolgov/files/WHD/flsa/ot-541-final-rule.pdf   FTC Act of 1914 https://www.law.cornell.edu/uscode/text/15/chapter-2/subchapter-I   FTC Final Rule, 16 CFR Part 910 https://www.ftc.gov/system/files/ftc_gov/pdf/noncompete-rule.pdf   Jimmy Johns noncompete https://www.huffpost.com/entry/jimmy-johns-non-compete_n_5978180   Amazon noncompete https://cdn1.vox-cdn.com/uploads/chorus_asset/file/3543196/AmazonContract.0.pdf   21 U.S.C. 812 https://www.law.cornell.edu/uscode/text/21/812   Congressional Review Act https://www.law.cornell.edu/uscode/text/5/part-I/chapter-8 Show Links: https://www.lawandchaospod.com/ BlueSky: @LawAndChaosPod Threads: @LawAndChaosPod Twitter: @LawAndChaosPod Patreon: patreon.com/LawAndChaosPod  

Series on "The Father" by Fr. Mark-Mary Ames, CFR (Part 5) What does it mean to be loved and celebrated? We are favored sons and daughters worthy of celebration—of being served. We are worthy and loved by God and this episode talks about a step in the right direction on what it means to be loved and celebrated. This is a gentle call to conversion and repentance, an invitation to allow ourselves to be loved sacrificially and give God and others permission to love and celebrate us. Here's the link to the graph that we referenced in the video: https://bit.ly/pocofreedomgraph The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

Summary In this episode of BioTalk Unzipped, the hosts discuss the applications and ethical concerns surrounding organoids, which are 3D cell clusters that mimic the features of full-sized organs. They explore the potential of brain organoids in brain-computer interfaces and neuroplasticity. The conversation then shifts to the impact of AI and data sciences in healthcare, with a focus on the challenges and opportunities in implementing AI strategies. The hosts also discuss the future of quantum computing in healthcare and the FDA's IT strategy with 21 CFR Part 11.  Chapters 01:14 - Introduction to BioTalk Unzipped 03:30 - NEW NEWS: Discussion on Organoids and Their Applications  04:45 - Ethical Concerns with Brain Organoids as mini bio-computers 06:31 - Organoid Possibilities in Drug Discovery Research and Brain Interfaces 08:59 - The Potential of Brain Training and Neuroplasticity 10:51 - The Impact of AI and Data Sciences in Healthcare 11:18 - Jason's Background and Emerging Technologies Transforming Clinical Research 13:43 - The Role of AI in Precision Medicine, Quantum Computing and Business Growth 24:15 - FDA's IT Strategy and the Challenges of Implementing AI 26:32 - The Importance of Strategy and Prioritization in IT, Data Integrity, and 21 CFR Part 11 How to reach us: Jason Burke https://www.linkedin.com/in/jasonburke/ Creo Inc. -  https://www.creoinc.net/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com/  New News Link: The many uses of mini-organs https://www.technologyreview.com/2024/03/08/1089612/the-many-uses-of-mini-organs/  Image Credits Brain - https://www.vecteezy.com/vector-art/658977-kawaii-cute-happy-brain-with-arms-and-legs UFO - https://www.pinterest.com/pin/swampthingy--675891856570360044/ #HealthcareInnovation #Organoids #AI #QuantumComputing #Podcast #BioTalkUnzipped #drugdiscovery

Series on "The Father" by Fr. Mark-Mary Ames, CFR (Part 4) What does it mean to be made for freedom? We are all called to live in freedom as sons and daughters of God. The reality is we are seen, loved, and chosen by God the Father and there's freedom when we experience that. In this episode, we're going through the mechanics of freedom and learn more about how the experience of home and trust can help us understand that a little bit deeper. Here's the link to the graph that we referenced in the video: https://bit.ly/pocofreedomgraph The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

Series on "The Father" by Fr. Mark-Mary Ames, CFR (Part 3) Can you imagine how you would gaze upon your newborn baby for the first time? This is the way the Father loves everyone. He's constantly looking at us and is constantly delighting in us. The Father always looks at us with the same delight, love, and rejoicing as a father looks at his newborn for the first time. This is how our Heavenly Father looks at us, delights in us, rejoices in us and contemplates us right now.  When we feel things that we feel far away, or we think we feel that there's such darkness or separation or walls, it's an illusion, it's not true. We are always gazed upon with love and intimacy. In this episode, we're discussing the intimacy the Father wants to invite us into.  The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry. The discussion unveils the complexities and common misconceptions surrounding QMS, drawing an intriguing analogy between building a QMS and crafting sourdough bread. Sara shares her extensive experience with FDA inspections and audits, emphasizing the essential, tailored approach needed for effective quality management.Sponsor:This episode is brought to you by Cleio Medical Device Design. Discover how Cleio can transform your medical device concepts into market-ready products at cleio.com.Key Timestamps:[02:15] - Sara recounts her experiences with FDA inspections.[05:30] - Etienne introduces the sponsor and the episode's focus on QMS.[12:00] - Sara explains what a QMS is and is not, breaking down the layers of quality control.[19:45] - Discussion on the practical steps to build and customize a QMS.[34:10] - Sara's sourdough analogy to illustrate the process of developing a robust QMS.[48:55] - Examples of how different QMS systems can meet specific regulatory requirements.[1:02:30] - Closing thoughts on keeping the patient in mind when building a QMS.Notable Quotes:"You can't buy a QMS off the shelf; it's like trying to bake sourdough bread without understanding the process or the ingredients." – Sara Adams"The patient should be the focus of everything we do in the medical device industry." – Sara AdamsKey Takeaways:Latest MedTech Trends:Increasing regulatory scrutiny on how QMS are implemented.More companies are moving from paper-based to electronic QMS for better compliance and efficiency.Growing emphasis on customizing QMS components to fit specific medical device regulatory needs.Practical Tips for MedTech Listeners:Understand the components of your QMS and ensure they align with regulatory requirements.Regularly review and update your QMS to adapt to new regulations and technologies.Consider electronic solutions for better traceability and compliance.Future Questions:What are the potential impacts of global regulatory harmonization on QMS?How can startups efficiently implement a compliant QMS with limited resources?References:FDA Quality System Regulation (21 CFR Part 820)ISO 13485 standards for medical devicesQuestions for the Audience:Poll: Do you believe that advances in electronic QMS will significantly reduce compliance issues in the next 5 years?Call for Feedback:Enjoy this episode? Leave us a review on iTunes and suggest topics you'd like to hear about in future episodes. Email us your feedback and ideas at podcast@greenlight.guruConnect with Us:Follow Etienne on LinkedIn: Etienne NicholsFollow Sara on LinkedIn: Sara AdamsJoin us next time for more insights and expert advice in the medical device industry!

Series on "The Father" by Fr. Mark-Mary Ames, CFR (Part 2) Do you know how much your heavenly Father delights in you? The part of the heart of the Father is to care for his children in whatever shape or form that would take. It might feel a lot or even tiresome but because of the uncalculated love of the father, the time when he gets to take care of and be with his children in this special way can be the best part of the father's day. In his children's poverty, in this exchange, and despite the challenges, there are still many things about them that allow the father's heart to well up with delight. The inabilities and imperfections that we have, delight the Father because they are occasions of intimacy and closeness to Him. This is the purity of the delight we're talking about in today's episode. This is a reminder that God delights in all of us even more as an earthly father delights in his earthly children. The heavenly Father is not burdened by you, be He profoundly delights in caring for you.  The Poco a Poco podcast happens because of many generous donors, including recurring monthly donations of any amount. Thinking about helping out? You can give at https://spiritjuice.org/supportpoco. Thank you!

On this episode, I was joined by Peter Baker, President @ Live Oak QA. The conversation revolves around the speaker's experience working with the FDA, starting from his time in San Francisco and culminating in his experiences in international locations like India and China. The discussion outlines the FDA's diverse focus areas, from food to medical devices and clinical trials, and how operational changes in the mid-2010s streamlined FDA's specialized areas. The speaker discusses his inspection methods and how a focus on critical thinking rather than procedural controls leads to more substantial findings, particularly in data integrity within quality control labs across industries. He emphasizes the need for quality-driven, honest investigations in addressing deviations and believes a switch from a compliance-focused mindset to a quality-oriented one should be the future standard. 00:00 Early Career and Diverse Experiences 00:43 Understanding FDA Regulations and Import Work 02:28 Moving Overseas and Program Realignment 07:44 Challenges with Data Integrity 10:33 Understanding the Root Cause of Data Integrity Issues 10:54 The Role of Data Governance and Regulatory Guidance 22:24 Challenges of Field Inspections 24:07 Manipulation of Product Quality 25:26 Jurisdiction and Quality Systems 27:53 Lab Controls and Data Integrity 36:04 Addressing Unknown Discrepancies 39:34 The Importance of Honest Reporting Peter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since 2019. Prior to consulting, Peter spent 11 years as a U.S. FDA Drug Investigator, with 7 of those years spent working in FDA's overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity and has special interest in big data management and compliance with 21 CFR Part 11. PIC/S Guidance on Data Integrity: https://picscheme.org/docview/4234 Live Oak: https://www.liveoakqa.com/ Peter's Blog: https://www.liveoakqa.com/blog-1

On this episode, I was joined by Khaudeja Bano, VP of Quality for Combination Products at Amgen. In this episode, the we discuss the details related to post-market safety reporting for combination products. The conversation extends to the comparison connecting safety and quality, the importance of cross-functional teams for risk management, and the approach towards health hazard assessments. Additionally, they delve into managing product responsibilities, the varied international reporting requirements, and the use of technology for improved efficiency. 00:54 Post-Market Safety Reporting 05:23 Challenges in Post-Market Safety Reporting 07:57 Reporting Databases 10:05 21 CFR Part 4b Guidance 11:50 Managing Product Responsibilities 19:12 Challenges in Handling Platforms 23:10 Understanding Health Hazard Assessment 25:32 International Approach to Reporting Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.

Sean was joined by Elliot Golding of McDermott Will & Emery to discuss all things HIPAA Privacy and Security, Information Blocking, and a few more critical aspects of cybersecurity! This episode is a must for all medical practices, hospitals and health systems to ensure your compliance with the ever-changing landscape! Elliot is Sean's go-to when it comes to Data Privacy and Cybersecurity! About Elliot Golding: Elliot Golding (CIPP/US) is a partner in McDermott Will & Emery's Data Privacy and Cybersecurity Practice. Elliot provides business-oriented privacy and cybersecurity advice to a wide range of clients, with a focus on health care/life sciences, technology (including "digital health"), ecommerce, financial, and other sectors that frequently handle personal information. His practical approach helps clients balance legal risk with business needs, particularly relating to innovative issues such as “digital health” technologies, the Internet of Things, data monetization, online advertising technology, big data and Artificial Intelligence/Machine Learning tools (particularly in the health research context). He has extensive experience helping clients navigate the patchwork of evolving legal standards and best practices, including:--Federal laws, such as HIPAA/HITECH, Information Blocking and Interoperability Rules, 42 CFR Part 2, GLBA, COPPA, health research rules, marketing rules (TCPA, CANSPAM, etc.), --US state laws, such as CCPA (and for coming laws in CA, CO, VA, CT, and UH), CMIA, CalFIPA, laws governing sensitive health and financial information, and state laws governing security and breach notification--industry standards (such as DAA/NAI self-regulatory principles, PCI-DSS, and security standards (such as NIST and ISO). Elliot has also handled hundreds of breaches and security incidents through all aspects of investigation, notification, remediation and engagement with regulators. He has received awards for his expertise from numerous publications, including Bloomberg and Global Data Review. Elliot also chairs several American Bar Association committees including the Privacy, Security and Emerging Technology Division; E-Privacy Law Committee, and Biotechnology, Healthcare Technology, and Medical Device Committee.

Join us as we welcome Steve Thompson in a special swap-cast episode that will be published here to Software Quality Today, as well as to the soon to be revamped and relaunched podcast from ValGenesis that Steve will be hosting.  Steve is a highly respected, extremely involved figure in the life sciences community and is currently the Sr. Product Marketing Manager at ValGenesis. In this episode, Dori and Steve sat down after several days of the KENX  “Lean Validation – Implementing CSA and Modernizing 21 CFR Part 11” conference to spend some time dissecting the event and some of the content presented. Some themes included where and how 21 CFR part 11 fits into the current landscape relative to its inception in 1997, the state of CSV at many organizations, as well as other relevant industry regulatory codes and guidances that come into play both from an FDA perspective, as well as global equivalents. What two better people to have a conversation to share insights and summarize a content rich event?Follow Steve on LinkedIn here and be sure to check out the ValGenesis podcast upon its triumphant return.In the meantime, please enjoy this episode and don't forget to subscribe, rate, and share.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Property is theft! - WikipediaFood Safety Talk 245: Peer Chicken — Food Safety TalkUrbanHens TO program must be cancelled | The StarConference for Food Protection2023 Biennial Meeting | Biennial Meetings | Conference for Food Protection‎www.foodprotect.org/media/biennialmeeting/council-iii-combined.pdfhttps://www.fda.gov/media/164194/downloadeCFR :: 21 CFR Part 1240 – Control of Communicable DiseaseseCFR :: 21 CFR Part 1250 – Interstate Conveyance SanitationThe Wire Clip: Omar “It's all in the game” - YouTube453. Wild Yeast Water — Risky or Not?(3) Merlin Mann on Twitter: “I used to say people who believe conspiracy theories have never had to manage a project. Today, I feel like folks who claim “A.I. will easily replace writers” have never had a boss, a client, a team, or even held…a regular job. It's like announcing forks will replace food.” / Twitterhttps://www.fda.gov/media/121202/download#:~:text=In%201969%2C%20FDA%20set%20an,to%20the%20lowest%20possible%20level.Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed | FDASalmonella Outbreak Linked to Flour | Salmonella | CDCWhen People Got Sick | Salmonella | CDCInvestigation Details | Salmonella | CDC(3) Merlin Mann on Twitter: “Really relieved our flour doesn't look like this. https://t.co/WiBifpietG” / TwitterCarla Schwan | UGA FACSThermal Inactivation of Salmonella enterica and Nonpathogenic Bacterial Surrogates in Wheat Flour by Baking in a Household Oven - ScienceDirecthttps://www.fda.gov/media/167640/download2023 Biennial Meeting | Biennial Meetings | Conference for Food Protection‎www.foodprotect.org/media/biennialmeeting/council-iii-combined.pdfGenetic changes are introduced by repeated exposure of Salmonella spiked in low water activity and high fat matrix to heat - PMCMultistate Outbreak of Listeriosis Linked to Whole Cantaloupes from Jensen Farms, Colorado | Listeria | CDC(12) Watch | FacebookGordon Lightfoot's ‘Wreck of the Edmund Fitzgerald' Was An Unlikely Hit - The New York TimesRheostatics - Melville - 11 The Wreck Of The Edmund Fitzgerald - YouTubeWest End Phoenix - Community Newspaper in Toronto

"See and Avoid" is widely recognized as a method for avoiding collision. This accident shows that approach has limits. The term "See and Avoid" is part of Federal Aviation Administration (FAA) Regulation 14 CFR Part 91.113 (b), calling for pilots to actively search for potentially conflicting traffic. John and Todd discuss a 2014 accident where two planes crashed because they were not able to see one another in time. The accident involved a Cessna 172 and a Searey homebuilt participating in a Experimental Aircraft Association Young Eagles program. The Cessna was overtaking the Searey as it descended and the two collided. Two people in the Searey were able to land. The Cessna crashed and the passenger and student onboard died. The NTSB probable cause cited failure to “see and avoid.” The Flight Safety Detectives explore the importance and limitations of relying on being able to see everything from the cockpit. They discuss how better preplanning by the two pilots involved could have avoided the collision. Related documents at the Flight Safety Detectives website: NTSB Final Report (PDF) Don't miss what's to come from the Flight Safety Detectives - subscribe to the Flight Safety Detectives YouTube channel, listen at your favorite podcast service and visit the Flight Safety Detectives website.

Steve discusses additive manufacturing for medical devices with Drew Richardson, Director of Additive and Component Development at Resolution Medical. Drew discusses their partnership with Carbon3D, the benefits of CLIP printing over conventional FDM printing, some of the interesting projects they've worked on, and more.Resolution Medical is a medical device manufacturer located in Minneapolis, MN. They are FDA registered in vitro diagnostic and in compliance with all applicable regulations, including the Quality System Regulation 21 CFR Part 820 and ISO 13485:2016.For more information, visit www.resolutionmedical.com Host: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Drew Richardson | Director of Additive and Component Development | Resolution MedicalAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US Extruder For video episodes visit www.us-extruders.com/podcasts

The fact that Garland has appointed a Special Counsel means an indictment is not coming in the very immediate future. HOWEVER, everything we know about Jack Smith tells us that this is a very serious step that is not good for Trump. Listen in and find out why! Also, the 11th Circuit AGAIN slapped down Judge Cannon's horrendous ruling. The oral arguments could have been a Law'd Great Media. Andrew brought some quotes and they are great. This is the first episode of our new format, so there is no T3BE! There will be 4 episodes next week, the two smaller ones will have the T3BE question and answer. Exciting! Links: 28 U.S. Code § 510 - Delegation of authority, 28 CFR Part 600 - GENERAL POWERS OF SPECIAL COUNSEL, 28 CFR § 600.7 - Conduct and accountability, Smith Appointment order, 28 CFR § 600.8 - Notification and reports by the Special Counsel, 11th-circuit-grants-stay.pdf, 11th-circuit-grants-stay.pdf, Trump still filing to Cannon, Another Eastman Loss, SCOTUS declines to intervene for Trump taxes

Josh Allen and Joe Lynch discuss Tive's validated, real-time visibility for pharma. Josh is CRO at Tive, a leading provider of real-time supply chain visibility insights that help logistics professionals actively manage their in-transit shipments' location and condition. About Josh Allen  Josh Allen joined Tive in April of 2022 as Chief Revenue Officer to build out the go-to-market team as the company continues to scale at a rapid pace. Allen's primary responsibilities include fortifying the long-term global sales strategy, hiring the required expertise across the team, driving aggressive revenue growth, and creating a culture of winning. He joined Tive after serving as CRO at two fast-growing Boston-based technology companies in Owl Labs and Drift (acquired by Vista Equity Partners). Prior to that, Allen served as SVP, North America Sales & Service at CarGurus (NASDAQ: CARG) where he led a team of more than 300 sales, service, and operations professionals during the company's most expansive growth period. He also spent a decade at LogMeIn (NASDAQ: LOGM), where he held a number of leadership positions, including VP of Sales for two of the company's three business units, and helped open and expand their international headquarters in Dublin, Ireland. Josh attended Bowdoin College and now lives in Lynnfield, MA with his wife and two daughters and spends any extra time he has coaching, training, playing music, or sharing stories with friends and family. About Tive Tive is a leading provider of real-time supply chain visibility insights that help logistics professionals actively manage their in-transit shipments' location and condition. With Tive, shippers and logistics service providers (LSP) eliminate preventable delays, damage, and shipment failures. Tive‘s solution provides data generated by its industry-leading trackers allowing clients to actively optimize their shipments, improve their customers' experience, and unlock supply chain insights in an actionable real-time manner. Key Takeaways: Validated, Real-Time Visibility for Pharma Josh Allen is the Chief Revenue Officer of Tive, a tech firm that provides location and condition data of critical shipments in real time to ensure on time and in full delivery. In the podcast interview, Josh and Joe talked about Tive's validated, real-time visibility solution for the pharmaceutical and biological industries. The pharma and biological industries require visibility solutions to comply with exacting regulations – and Tive meets those requirements. Tive's pharma compliance is outlined below: FDA 21 CFR Part 11 and EU Annex 11 compliance: Ensures electronic records can be trusted in the same way as handwritten records. 3-Point NIST® traceable Certificate of Calibration included with every Tive tracker: Tive Solo 5G trackers and probes are fully calibrated by an ISO 17025 accredited laboratory. GxP-compliant: Tive's solution follows the guidelines of Good Manufacturing Practices (GMP). All the components (hardware and software) are developed and tested following the Good Automated Manufacturing Practice 5 (GAMP 5) model. The bar is higher for medical and pharmaceutical shipments because a shipment that is late or out of temperature range could cause loss of life. The Tive Tracker is about the size of a deck of cards, and it captures and transmits shipment data in real time with unprecedented accuracy. The Tracker provides real time alerts that enable shippers and their 3PL partners to respond and recover the shipment in the case of temperature breech, tampering, shock, damage, theft, and a variety of other factors. Tive enables shippers and their carrier partners to move from reactive to proactive, which is so important when transporting medical/pharma shipments. Tive provides flexible, scalable solutions bringing end-to-end visibility to supply chain professionals. In additional to medical and pharma, Tive provides solutions for the following supply chain problem areas: Location Tracking for High-Value Goods Chemicals Condition Monitoring Handling Damage Monitoring Damage Alerts for Electronics Shipments Port Delays Environmental Monitoring for Perishables Equipment Delivery Monitoring Automotive Supply Chain Optimization Learn More About Validated, Real-Time Visibility for Pharma Josh on LinkedIn Tive on LinkedIn Tive website Tive pharma solution page Biocair case study Optimize Courier case study Mercury case study Tracking Medical Shipments with Alex Guillen The Tive Story with Krenar Komoni The Logistics of Logistics Podcast If you enjoy the podcast, please leave a positive review, subscribe, and share it with your friends and colleagues. The Logistics of Logistics Podcast: Google, Apple, Castbox, Spotify, Stitcher, PlayerFM, Tunein, Podbean, Owltail, Libsyn, Overcast Check out The Logistics of Logistics on Youtube

Do you want to talk relocation assistance under the Uniform Relocation Act?  You have come to the right place!  Join Infrastructure Junkies! as Kristen Bennett takes us on a deep dive into the differences between moving, reestablishment, and ineligible relocation expenses.  This episode was inspired by a recent encounter with a move planner, and Kristen will discuss grease traps, vent hoods, and sprinkler systems…along with other sometimes questionable relocation items.  Also, find out when and how displacees can be reimbursed for expenses pertaining to code compliance.  Kristen will even give listeners direct references to the rules in the Code of Federal Regulations (49 CFR Part 24) and the Uniform Relocation Assistance and Real Property Acquisition Policies Act (Uniform Act)!  Let's get in the weeds together!

There's still SO much to talk about in the Mar-a-Lago Treason Trove! Lots of updates on that, plus the Weiselberg plea, Trump passports, and more! We also squeeze in a wildcard on Alex Jones's loser lawyers. Links: The Atlantic article that is wrong, 42 U.S. Code § 2274 - Communication of Restricted Data, Jonathan Toebbe case, 10 CFR Part 1045 -- Nuclear Classification and Declassification, Classification of Nuclear Weapons-Related Information, Dep't of the Navy v. Egan, Trump's passports returned, Norm Pattis Sanctions order, Reynal order, Pattis "moved to dismiss", Alex-Jones-Kyng-S.-Lee-Affidavit

What are guerilla tactics for quality leadership? How do you implement a lean quality management system (QMS) and put requirements in place that are truly required - especially when there is the potential for personnel to resist change? In this episode of the Global Medical Device Podcast, Etienne Nichols discusses lean QMS implementation with Steve Gompertz, a leader in quality systems management with more than 30 years of experience in the medical device/technology industry. Some of the highlights of this episode include:Guerilla tactics for quality leadership that involve thinking outside of the box and trying to get things done without asking for permission from authorities. Sometimes the FDA unintentionally creates fear and creates imaginary boundaries in people's minds that stifle their creativity.People will struggle and become frustrated when working with a burdened QMS and restrictive standard operating procedures (SOPs).The regulations and standards are intentionally vague and open to interpretation because it's not possible to have a one-size-fits-all. Meet the intent of the requirements and be ready to defend them.Lean documentation is the best approach. Weed out the things you don't need. In a regulated or unregulated space, it's better to have clear, precise, and intentional documentation rather than a pile of papers.Sometimes regulations and standards create negative opinions because it's human nature to not want to be told what to do. However, what is their purpose? To produce safe and effective medical devices while also turning a profit.Approaches to implementing guerilla tactics include burying or sneaking something in without calling it what it is and getting people to do the right thing without them always knowing they are doing it.Make sure your metrics don't incentivize the wrong thing. Some companies measure document control in QMS based on time—how fast it takes to make changes? But does that actually make the process more effective and cost less? More likely, it incentivizes cutting corners.Steve recommends shifting your mindset about document control or value-added changes by first defining the problem correctly. Don't make assumptions.Memorable quotes from Steve Gompertz:“The regs and the standards aren't actually that specific too often. They are intentionally vague. Sometimes, that is a point of frustration with people. But when you think about it, they have to be.”“Step back, stop just reading what the words say, and start thinking about why are they there?”“When you create a quality system, you have to think about the architecture.”“If it isn't documented, right, it didn't happen. If it's not documented right, things are going to go bad.”Links:Quality & Regulatory Consulting - QRx PartnersAsk Me Anything Session with Steve GompertzISO 13485FDA - Guidance Documents (Medical Devices)21 CFR Part 820 - Quality System RegulationThe 7 Habits of Highly Effective People by Stephen R. CoveyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru

This is first installment of our look at what "Made in America" really means when it comes to motor vehicle manufacturing.  We start by taking a look at the federal American Automobile Labeling Act - otherwise known as 49 CFR PART 583 in federal parlance.   Beginning with the 1994 model year, the nation's automakers were required to displace content information on each and every passenger car and light truck which gave consumers a better ideas about where major vehicle components were manufactured and where final assembly of the vehicle took place.  It was a great first step, but continues to have problems.  We discuss. 

If you are a new FSO, there is no reason to travel your journey alone. You may recruit fellow employees to assist with the tasks. Additionally, there are many resources available to assist with FSO responsibilities to include DCSA, NISPOM, professional organizations, consultants, books and training are available just for this purpose.Lately, contract language requires the contractor to conduct tasks in support of Program Protection Planning (PPP), Supply Chain Risk Management (SCRM), Criticality Analyses (CA), and providing Program Protection Plan Implementation Plans (PPIP). These requirements include language that requires developing PPIPs, protecting critical components, developing SCRM plans, quantifying risk to the supply chain, vetting vendors and so much more. The ISP and ISOC Master exam prep for NISPOM 32 CFR Part 117 is now available. If you plan to test in winter 2022 or later, make this version part of your study plans.Check it out. While this may not be an organic capability for most organizations, there are many small companies that can step up and provide the necessary guidance or share in the workload. Classified information should only be reproduced in response to a contractual requirement such as in the performance of a deliverable. Reproduction should not be made as a matter of convenience as it puts classified information at unnecessary risk and it requires dedicated resources. The FSO can enforce resource discipline with:1. Creating processes and procedures identifying reproduction only as necessary and using only approved equipment 2. Ensuring only trained and authorized personnel are able to reproduce classified information. 3. Identifying office equipment, copy machines, scanners and other reproduction equipment for classified information reproduction. All other enterprise equipment should be off limits to classified reproduction.Link to NISPOM and cleared contractor security books.Link to NISPOM required trainingRed Bike Publishing Providing security clearance books, training, and resources for cleared defense contractors.Bennett Institute Online security clearance webinars and coaching. Providing security training and resources.Mission Driven Research, Inc Mission Driven Research, Inc is a growing company providing technical services to the US government.Access Commander by MathCraft We support the mission of FSOs, CSOs and other security professionals. SIMS Software SIMS suite provides features/functionality you need to run automated industrial security programs. Support the show

On this episode, I was joined by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss: - Safety function (Drug vs. Device) - 21 CFR Part 4 Subpart B - Specific Post-Market Safety Reporting Expectations - Industry Challenges with implementing PMSR Requirements - Working in Quality with a background in Safety - Self Marketing, Toastmasters and Professional Development Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.

This episode of Ropes & Gray's podcast series Non-binding Guidance explores recent FDA guidance on recall readiness and other recall-related hot topics. In recent months, we have seen a trend of increased FDA inspection and enforcement activity as the impact from COVID-19 starts to lessen. Earlier this year, FDA also finalized guidance on the Initiation of Voluntary Recalls under 21 CFR Part 7, Subpart C, which explores FDA expectations regarding the process companies should already have in place ahead of a potential recall situation. Join Ropes & Gray FDA regulatory attorneys Josh Oyster and Beth Weinman as they provide a quick refresher on recalls and discuss the latest recall readiness suggestions from the Agency to help companies make decisions about how and when to recall their FDA-regulated products and how to involve FDA in that process. They also discuss FDA's recent recall-related actions that invoked rarely-used legal authorities applicable to medical devices.

The answer may surprise you! When it was announced that Elon Musk bought Twitter, I had a billion and one questions for Andrew about it. Andrew being Andrew, he commenced deep-diving and turned up a ton of interesting info about this deal and the legality around deals like this. And to his surprise... it's FAR from a done deal! Listen in for the dive so deep that it actually will require a surprise bonus episode! This is part 1, part 2 will be out as soon as thomasly possible to edit and release it! Links: Surely We Can Do Better Than Elon Musk, Elon, you have no idea what the hell you're talking about, 15 US Code Chapter 2B - SECURITIES EXCHANGES, 17 CFR Part 240, 17 CFR § 243.100 - General rule regarding selective disclosure, 17 CFR § 243.101 - Definitions, Form 8-K, 17 CFR § 240.10b-5 - Employment of manipulative and deceptive devices, Basic, Inc. v. Levinson, 485 U.S. 224 (1988), Twitter's 8k, material agreement with Musk

In this episode, Kyle Rose from Rook Quality Systems and Duane Mancini discussthe FDA's ISO-13485 transition plan, when it was announced, what it looks like, the differences 21 CFR Part 820 vs. ISO 13485, the importance of a risk based approach in quality, updates on the MDR and current trends, could the FDA move towards requiring more clinical data from medical device manufacturers, if regulatory and quality were the only factors in determining your global get-to-market strategy…where would you go, and so much more. Kyle Rose LinkedIn Rook Quality System Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device industry and regulatory bodies?In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences and George Zack of Two Harbors Consulting about the changes unfolding and the pros and cons of harmonization between QSR and ISO 13485:2016—a standard not governed by FDA.Some of the highlights of this episode include:The FDA is not expected to adopt ISO 13485 or any other standards across the board. Instead, it will take a piecemeal approach. Any future revisions to the 2016 version of the standard would need to be evaluated before becoming part of U.S. regulations.How often are periodic changes and updates made to QSR, ISO standards, and FDA guidances? Do changes even need to be made or are they a waste of time and money? Good regulation is agnostic of time and technology.Government bodies in different parts of the world want to protect their citizens. Will there ever be global harmonization for quality? Are the most important principles of quality a function of geography? No, quality is quality.The timeline to transition is one year, but companies and inspectors may need or want more time due to a limited number of resources and notified bodies.If a company does what it should do for the safety and efficacy of medical devices, it should really be a tiny or no leap at all to make changes. The only changes are in the paperwork and forms.Medical device professionals should know about ISO 13485. If they do not know about this standard, whether it is required or not, that could be a problem.For those adhering to ISO 13485, if there are new requirements that make sense from a biology and engineering perspective, that's the way to do something.Memorable quotes from this episode:“They are not going to adopt ISO or any other standards across the board. They'll take sort of a piecemeal approach, and I think that makes sense.” Mike Drues“When was the last time that the design control guidance was updated since it was created in 1997? The answer is, never. That guidance has remained exactly the same.” Mike Drues“Good regulation is timeless.” George Zack“While it might not be a huge shift, I think it is a step in a direction of many steps toward some sort of global harmonization.” George ZackLinks:ANSI/AAMI/ISO 13485:2016 HandbookNIST's "ABC's of Conformity Assessment"International Medical Device Regulators Forum (IMDRF)ISO 13485:201621 CFR Part 820 - Quality System RegulationFDA - Design Control Guidance for Medical Device ManufacturersFDA - Case for Quality ProgramFDA - Medical Device Single Audit Program (MDSAP)European Union Medical Device Regulation and In Vitro Diagnostic Regulation (EU MDR and IVDR)Mike Drues of Vascular Sciences on LinkedInGeorge Zack of Two Harbors Consulting on LinkedInTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

On this episode, we were joined by Susan Neadle. If you work on Combination Products, Susan is someone you need to know. Her and I discuss: Her career starting in consumer health and pivoting into Medical Devices then Pharmaceuticals Design to Value, Design Excellence and Process Excellence The History of Combination Products regulation and what it was like implementing 21 CFR Part 4 as it was revealed. Creating future plans using tools like the Merlin Exercise, and Future/Back Vocabulary in Combination Products AAMI TIR 48 and TIR 105 Her involvement in ASTM, AAMI, ISPE, FPIA, DIA, AFDA, TOPRA and RAPS Prioritization, Passion and her upcoming book ------------------------------------- Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience. Networked, published, highly active in numerous industry groups and with links to a number of teaching institutions, Susan brings deep knowledge, and genuine passion for sharing that knowledge, with others. Susan's leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA's 2021 Awards for Regulatory Affairs Excellence. She is Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership and technical skills and experience to provide hands-on design-to-value, program management, quality & compliance, and regulatory consulting services, for pharmaceutical, biotech and medical device industries. Among her many significant industry affiliations and contributions, she serves as Chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee, and teaches a Master's Curriculum on Combination Products at University of Maryland Baltimore Campus. Most recently, Susan served as Head of Combination Products, Medical Devices, Digital Health & IVD Regulatory Affairs at Amgen, providing strategic leadership in global combination products/ device regulatory development and portfolio/project management from initial clinical investigation through registration and commercial lifecycle. She served as an advisor for internal regulatory policy priorities, health authority engagement and submissions approaches through strategic engagement and mentoring of colleagues for individual projects and portfolio. She led interactions with multiple global health authorities, and served as a catalyst for external consortium deliverables and strategic direction. Susan retired from Johnson & Johnson. Her distinguished career there of more than 25 years included integral leadership roles in R&D, Quality Engineering, Design-to-Value, Risk Management and Quality Systems, spanning pharmaceuticals, medical devices, and consumer health sectors, including strategic Enterprise leadership as Chair of J&J's Design Council, advancing world-class practices in customer-centric product/process design and development. She led the team that defined and successfully implemented the globally integrated business model to meet Combination Products regulations for Janssen.

How efficient are your management reviews? Could improvements be made? It might be time to reevaluate and reconfigure your system processes to eliminate burdens and extract utmost value from these critical checkpoints while still satisfying compliance needs.In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, senior medical device guru at Greenlight Guru. Together, Taylor and Jon discuss the nuances of management reviews to help medical device managers and executives make better decisions for teams to achieve greater outcomes.Some of the highlights of this episode include:Learn the must-haves of management reviews, such as inputs, feedback, complaints, reporting, and audits during planned intervals, by following ISO 13485 and FDA 21 CFR Part 820 - Quality System Regulation.How often should management reviews be performed? The industry standard is once a year, but a lot could happen in 12 months. Greenlight Guru recommends management reviews twice a year, especially in the early parts of your business.Internal audits and management reviews are two activities that offer a snapshot in time of the overall picture of the health of your QMS. Then, the management review is a platform to escalate issues.Best practices for a management review include where more research, time, and effort should go. Don't mistake a management meeting for a review. Pulling off a management review last minute is a lot easier than an internal audit.Your company's key performance indicators (KPIs) and goals should be put on the agenda as a checkbox activity for the management review. Yet the list of topics/objectives should be discussed to assess how you handle your business.Document any decisions and actions to maintain the suitability, adequacy, and effectiveness of your QMS. In meeting minutes, include an action plan and product improvements related to customer requirements and correct problems.You can share your management review meeting minutes with notified body auditors, but not the FDA.If you have to hurry up and hustle to get data, is it reality data that you need? Is it that important? Automate, divide, and conquer.Memorable quotes from this episode:“The standard is pretty general on how often you should be doing management reviews.” Taylor Brown“Management review is really a platform to escalate issues.” Taylor Brown“Pulling off a management review last minute is a lot easier than trying to pull off all of your internal audits last minute.” Jon Speer“Executive management needs to be aware of and involved with the health of the quality system.” Jon SpeerLinks:ISO 13485 - Medical DevicesFDA - 21 CFR Part 820 Quality System (QS) RegulationTaylor Brown on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru