POPULARITY
13 episodes with cfr part
12 episodes with cfr part
4 episodes with cfr part
3 episodes with cfr part
4 episodes with cfr part
5 episodes with cfr part
5 episodes with cfr part
2 episodes with cfr part
2 episodes with cfr part
Episode: 00323 Released on June 15, 2026 Description: Chris Mason has spent more than two decades serving as a law enforcement analyst with the Riverside County Sheriff's Department. Along the way, he has worked assignments in criminal intelligence, homicide, station operations, and public health overdose surveillance. He also serves as a director for the Association of Law Enforcement Intelligence Units (LEIU). In this episode, Chris discusses his journey from aspiring police officer to analyst, the importance of networking, intelligence operations, interdisciplinary partnerships, leadership, adapting to change, and the role analysts play in supporting public safety beyond traditional crime analysis. He also shares lessons learned from career setbacks, the importance of marketing analytical value, and why understanding your "why" can help sustain a long and fulfilling career.
If your agency receives grant funding, chances are you've been asked to share said organization's most recent annual audit. And if enough federal funds are involved, a single audit may be necessary. Let's dive into the reason for each to ensure you're meeting funder (and other) requirements. JOIN THE FUNDRAISING HAYDAY COMMUNITY: Become a member of the Patreon CHECK OUT TODAY'S SPONSOR: GrantGuru Use discount code HAYDAY963 for 20% off your subscription SHOW NOTES: S2, E10 Podcast Episode: I Survived an OIG Audit & Lived to Tell the Tale - HayDay Services Uniform Guidance Audit Section eCFR :: 2 CFR Part 200 Subpart F -- Audit Requirements
The American Democracy Minute Radio News Report & Podcast for June 10, 2026What Could Go Wrong with Trump's Mail-In Voting Executive Order and The USPS Plan to Implement It? Bad Data, for One Thing.In our last report, we shared the U.S. Postal Service's plans for implementing President Trump's executive order for verifying the citizenship of mail-in voters. The flawed data on which the plan relies may result in election chaos and voters being disenfranchised. Some podcasting platforms strip out our links. To read our resources and see the whole script of today's report, please go to our website at https://AmericanDemocracyMinute.orgToday's LinksArticles & Resources: The White House - ENSURING CITIZENSHIP VERIFICATION AND INTEGRITY IN FEDERAL ELECTIONSU.S. Postal Service via The Federal Register - Proposal to Comply President Trump's Executive Order: POSTAL SERVICE 39 CFR Part 111 Ballot Mail for Federal ElectionsBrennan Center for Justice - Analyzing the President's Executive Order on Mail Voting Fair Elections Center - Eligible Voters at Risk: Examining Changes to USCIS's SAVE System Texas Tribune/ProPublica - A federal tool to check voter citizenship keeps making mistakes. It led to confusion in Texas.Protect Democracy - The SAVE tool, explained Protect Democracy - The ‘SAVE' Tool Could Disenfranchise U.S. CitizensAmerican Immigration Council - The Systematic Alien Verification for Entitlements (SAVE) Program: A Fact SheetRelated ADM Reports:American Democracy Minute - Federal Circuit Courts Block Trump DOJ from Obtaining California and Oregon Voter DataRegister or Check Your Voter Registration:U.S. Election Assistance Commission – How to Register And Vote in Your State Please follow us on Facebook, Instagram, and Bluesky Social, and SHARE! Find all of our reports at AmericanDemocracyMinute.orgSubscribe for FREE at Apple Podcasts, Spotify and most podcasting platforms.#NewsAlerts #AmericanDemocracy #TrumpExecutiveOrders #USPS #SAVEDatabase #Disenfranchised
The American Democracy Minute Radio News Report & Podcast for June 9, 2026In Response to Executive Order Federalizing Mail-In Voting Rules, the U.S. Postal Service Proposes Rules to Verify Voter EligibilityRecently, a federal court allowed - for now - President Trump's executive order governing mail-in ballots. The US Postal Service has been tasked with implementing much of the order, and USPS just proposed how the process will work.Some podcasting platforms strip out our links. To read our resources and see the whole script of today's report, please go to our website at https://AmericanDemocracyMinute.orgToday's LinksArticles & Resources:The White House - ENSURING CITIZENSHIP VERIFICATION AND INTEGRITY IN FEDERAL ELECTIONSU.S. Postal Service via The Federal Register - Proposal to Comply President Trump's Executive Order: POSTAL SERVICE 39 CFR Part 111 Ballot Mail for Federal Elections CyberScoop - USPS moving forward with mail-in ballot changes as courts weigh Trump's election order Brennan Center for Justice - Analyzing the President's Executive Order on Mail Voting Related ADM Reports:American Democracy Minute - Federal Court Allows Trump Order Federalizing Mail-In Voting Rules to Proceed Because Voters Haven't Been Harmed – YetAmerican Democracy Minute - Trump Issues Executive Order Attempting to Federalize Mail-In Voting Rules and Establish ‘State Citizenship List'. It's Beyond His Authority.Groups Taking Action:Common Cause, National Vote at Home Institute, Asian Americans Advancing Justice, American Postal Workers UnionRegister or Check Your Voter Registration:U.S. Election Assistance Commission – How to Register And Vote in Your State Find all of our reports at AmericanDemocracyMinute.orgSubscribe for FREE at Apple Podcasts, Spotify and most podcasting platforms.#NewsAlerts #AmericanDemocracy #MailInVoting #VoteatHome #TrumpExecutiveOrder #USPS
US-Tech ist überall – beim Bezahlen, Buchen und Arbeiten. Der Fall eines französischen Richters zeigt, wie konkret unsere digitale Abhängigkeit ist. Marcus und Bo fragen: Was passiert, wenn die USA den Stecker ziehen? **********Podcast-Empfehlung: Inside CumEx – Jagd auf die Steuer-MafiaInside CumEx – Jagd auf die Steuer-Mafia**********In dieser Folge:1:54 - Der Fall Nicolas Guillou6:03 - Wie abhängig sind wir von US-Firmen?15:21 - Neue Alternativen fürs digitale Bezahlen22:19 - Fazit / Wahres für Bares23:50 - Podcast-Empfehlung: Xatar - Legacy**********An dieser Folge waren beteiligt: Autoren: Marcus Wolf, Bo Hyun Kim Faktencheck: Paulina Lange, Jule Dieterle Redaktion: Michael Böddeker Produktion: Chrouki Gustmann**********Die Quellen zur Folge:Verfassungsblog: Sanctions against the ICC by the United States.U.S. Electronic Code of Federal Regulations: 31 CFR Part 501, Appendix A to Part 501 – Economic Sanctions Enforcement Guidelines.Europäische Kommission: New EU rules make instant euro payments faster and safer.**********Weitere Beiträge zum Thema:Rette sich, wer kann: Das neue AltersvorsorgedepotRoboter-Revolution: Per Kung-Fu Kick in die Arbeitslosigkeit?Cotti Coffee: Wie Chinas Franchises die Welt erobern **********Habt ihr auch manchmal einen WTF-Moment, wenn es um Wirtschaft und Finanzen geht? Wir freuen uns über eure Themenvorschläge und Feedback an whatthewirtschaft@deutschlandfunknova.de.**********Den Artikel zum Stück findet ihr hier.**********Ihr könnt uns auch auf diesen Kanälen folgen: TikTok und Instagram .
Host: Lalo Solorzano and Andy Shiles Guest(s): Josh Rodman Published: May 20, 2026 Length: 31:53 Presented by: Global Training Center Summary Export compliance is not always as simple as checking an ECCN, screening restricted parties, and moving forward. In this episode, Lalo Solorzano and Andy Shiles speak with Josh Rodman, Senior Attorney with Schulz Trade Law, about a lesser-known export control issue involving Russia, Belarus, and outbound HTS-based controls under Part 746 of the EAR. Josh explains why Russia and Belarus are different from most export destinations: certain products may trigger export licensing requirements based on their HTS code, even when the product appears to be EAR99 and even when the shipment is not going directly to Russia or Belarus. The bigger concern is diversion risk, especially when goods are shipped to high-risk jurisdictions such as Kazakhstan, the UAE, certain “STAN” countries, or other locations where products may later be transferred. The conversation also covers routed transactions, USPPI responsibilities, the importance of accurate ECCN and HTS classification, shipper's letter of instruction documentation, written procedures, customer due diligence, and when companies may need to consider licensing or deeper review before proceeding. Main Topic / Discussion This episode focuses on how U.S. exporters can identify and manage export control risks tied to Russia and Belarus, even when they are not selling directly into those countries. Josh Rodman explains that Part 746 of the EAR creates outbound HTS-based controls for certain products destined for Russia or Belarus, or for transactions where there is a significant risk of diversion. The discussion highlights how exporters can miss this issue if they only rely on ECCN analysis, restricted party screening, or standard export procedures. The hosts and guest also explore routed transactions, domestic sales that may later become exports, distributor risk, documentation practices, and the need for written compliance procedures and training. Key Takeaways • Russia and Belarus are unique because certain export controls are tied to outbound HTS codes, not only ECCNs. • An EAR99 product may still require deeper review if the HTS code appears under Part 746 and there is a risk of diversion to Russia or Belarus. • Exporters should not rely solely on customer assurances, especially when working with new distributors in higher-risk jurisdictions. • Routed transactions do not eliminate the U.S. seller's responsibilities; the USPPI should provide accurate ECCN information through the SLI. • Written procedures, trained staff, accurate classifications, customer diligence, and documentation can help protect companies when export risks arise. • Export opportunities remain strong, but companies need a solid compliance foundation before pursuing higher-risk international sales. Resources & Mentions • Global Training Center • Schulz Trade Law • International Compliance Professionals Association • Bureau of Industry and Security • 15 CFR Part 746 – Embargoes and Other Special Controls Credits Host: Lalo Solorzano Andy Shiles Guest(s): Josh Rodman Producer: Lalo Solorzano
Welcome to your weekly UAS News Update. We have five stories for you this week; the FAA dropped Section 2209 NPRM, the public comment window is closing on DJI's FCC Covered List challenge, a record-breaking 218 drone incursions over wildfires last year, ACSL is Partnering with Draganfly, and today marks 7 years of uninterrupted drone news! First up this week, the FAA has finally filed its long-overdue Section 2209 Notice of Proposed Rulemaking, or NPRM. This opens a 60-day comment window that will determine how fixed-site facilities can apply for permanent drone restrictions over their property. The 181-page rule creates a new 14 CFR Part 74 framework with two tiers: a Standard Unmanned Aircraft Flight Restriction and a Special UAFR. The FAA proposes limiting eligibility to 16 critical infrastructure sectors, which could encompass more than 9,000 eligible facilities. The proposed rule includes a transit lane for commercial operators! Drones operating under Parts 91, 107, 108, 135, and 137 will be allowed to transit a Standard UAFR if they broadcast Remote ID, transit in the shortest practicable time, and notify the facility. Unfortunately, recreational flyers are not on that list. This rule explicitly does NOT grant facility operators counter-drone authority, such as jamming or drone capture. It is strictly an airspace designation. Next, the deadline to submit public comments on the FCC petition regarding DJI's placement on the Covered List is rapidly approaching on May 11, 2026. DJI is challenging the FCC's December 2025 decision that effectively blocks the authorization of new affected products for sale or import into the United States. DJI has pursued legal action in the U.S. Court of Appeals for the Ninth Circuit. So far, more than 460 comments have been submitted, and the Department of Defense has recently urged the FCC to reject DJI's petition.Third up, the U.S. Forest Service reported a staggering 218 drone sightings over active wildfires in 2025. Most of these happened during the Eaton and Palisades, which includes the one on January 9, 2025 where a privately flown drone actually collided with a Canadair CL-415 Super Scooper aircraft, punching a 3-by-6-inch hole in the left wing. Remember, DJI removed mandatory geofencing enforcement from its consumer drones in early 2025, shifting to advisory warnings. Check for TFRs on tfr.faa.gov.Next up, Draganfly Inc. and ACSL signed an exclusive master distributor agreement on May 7, 2026, making Draganfly the sole Canadian distributor of ACSL's drone technology. The agreement also includes technical integration work between the two companies' platforms. The initial product offering is the ACSL SOTEN. Under the integration component of the agreement, Draganfly's Apex and Commander 3XL drones will be made compatible with SOTEN's swappable payloads and the TAITEN ground control station, allowing operators to mix components across both manufacturers' systems. SOTEN joins Draganfly's existing lineup of Apex, Commander 3XL, and Heavy Lift platforms.And last up, Today marks 7 years of uninterrupted drone news! We've covered a ton of ground since we started, with over 460,000 students, over a million enrollments, including 148,000 Part 107 students, 61,000 free stickers, which will continue to be free thanks to community donations, over 28,000 active members in our community, over 365,000 free TRUST certificates issued, and over 19,000 WINGS credits issued on the FAASafety platform. Thank you for your support! We'll see you on Monday for the live and on post flight in the premium community!https://dronelife.com/2026/05/05/public-comment-window-closing-fcc-weighs-dji-challenge-to-covered-list-ruling/https://dronexl.co/2026/05/01/218-wildfire-drone/https://dronexl.co/2026/05/05/faa-section-2209-nprm-drops/https://acsl-usa.com/https://draganfly.com/
In this episode, host Etienne Nichols sits down with industry veteran Mike Drues to explore a critical theme in modern MedTech: the danger of "not knowing what you don't know." The conversation centers on the growing trend of companies making avoidable, "boneheaded" mistakes despite a robust regulatory framework. Mike Drues emphasizes that while technology evolves, the fundamental responsibility for safety and effectiveness remains non-delegable.The discussion dives deep into a landmark regulatory event: the first-ever FDA warning letter issued to a company for GMP violations specifically linked to the unauthorized use of Artificial Intelligence in manufacturing. They break down the legal and ethical implications of relying on AI agents to generate specifications and production records without human oversight or process validation.Finally, the episode tackles the controversial idea of individual accountability in regulatory citations. Etienne and Ryan debate whether naming specific professionals in warning letters would curb the repeat of industry-wide errors or if internal company culture provides enough of a corrective force. It's a sobering look at why professionals must keep their "brains at the door" and treat AI as a tool, not a replacement for human judgment.Key Timestamps00:02:15 - The "Preamble to the QSR": Why the "why" behind the regulation is more important than the "what."00:04:10 - The Non-Delegable Rule: Why AI agents cannot hold responsibility for quality requirements.00:07:30 - Case Study: The first FDA warning letter for AI-related GMP violations (Pure Parolia).00:10:45 - The Quality Unit: Does the "Quality Unit" legally need to be a human being?00:15:20 - Individual Accountability: The debate over naming names in official FDA warning letters.00:20:45 - The Autopilot Metaphor: Comparing AI in surgery to autopilot in aviation and self-driving cars.00:23:10 - Star Trek's "The Ultimate Computer": Lessons from 1968 on over-delegating to technology.00:27:15 - ClinicalTrials.gov: Analysis of the 30% non-compliance rate in clinical trial reporting.Quotes"The responsibility for meeting these requirements may not be delegated, even though the actual work may be delegated. This applies to artificial intelligence agents." - Mike Drues"True knowledge is knowing what you know and knowing what you don't know, and most importantly, knowing the difference between the two." - Mike DruesTakeawaysRead the Preambles: Don't just follow the letter of the QMSR; read the Preambles to understand the FDA's underlying logic and "thinking."AI is an Intern, Not a Manager: Treat AI as a "PhD-level intern." It can draft justifications or specifications, but it cannot "approve" them.Validate the AI Process: If AI is integrated into manufacturing or quality decisions, it requires process validation just like any other automated system.Human-in-the-Loop: Maintain a "Human-in-the-Loop" protocol for all regulatory submissions to prevent "garbage in, garbage out" errors.Check Clinical Reporting: Ensure all required clinical trial results are published on ClinicalTrials.gov; nearly a third of the industry is currently failing this basic requirement.ReferencesFDA Preamble to the QSR: The foundational text explaining the "why" behind quality regulations.21 CFR Part 211.22: The regulation defining the responsibilities of the Quality Control Unit.Pure Parolia Warning Letter: The April 2026 citation regarding AI and process validation.Star Trek Episode 24 ("The Ultimate Computer"): A cultural cautionary tale on over-reliance on machines.Etienne Nichols' LinkedInMedTech 101: Process ValidationThink of Process Validation like a recipe for a cake. If you're a baker, you don't just hope the cake turns out right every time; you test the oven temperature, the mixing time, and the ingredients to prove that if you follow the steps, you get a perfect cake 100% of the time.In MedTech, when a company uses AI to make decisions or manufacture parts, they must "validate" the process. This means proving that the AI (the oven) works correctly and consistently before selling the product. Claiming "the AI didn't tell me I had to test it" is like a baker saying they didn't know they had to turn the oven on because the recipe didn't mention it.Feedback Call-to-ActionWe want to hear from you! Do you think the FDA should start naming names in warning letters? Should the "Quality Unit" be legally required to be a human? Send your thoughts, reviews, or suggestions for future topics to podcast@greenlight.guru. We read every email and pride ourselves on providing personalized responses to our community.SponsorsThis episode is powered by Greenlight Guru. In an era where you cannot delegate your quality responsibility to AI, you need tools that empower your human experts. Greenlight Guru's QMS (Quality Management System) and EDC (Electronic Data Capture) solutions provide the "regulatory logic" and data integrity needed to ensure your team stays compliant, from clinical trials through post-market surveillance. Connect your quality processes and clinical data seamlessly to avoid the "boneheaded mistakes" discussed today.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're discussing the FDA's recently implemented QMSR. It went into effect on February 2nd and replaced 21 CFR Part 820. The regulation incorporates ISO 13485:2016, which is expected to help align medical device regulations globally. In this podcast, we focus on what device manufacturers should be doing now and what can wait for a later time. During this conversation, the following questions are addressed:As most are already familiar with QMS and now QMSR, we'll dive deeper. Can you tell me if all sections of the QMSR listed in the QSR are required for all medical devices?Is a full QMS required to be in place in order to secure FDA clearance or approval?What about the sections of the QMSR? Are all of them equal in terms of importance? Are some sections more important than others?When do I need to have a QMS in place?What if I never intend to market my device? First, maybe provide an example of when that would be the case, and then address the first part.Should all QMS systems look the same?Are there differences with the QMSR with premarket vs. postmarket?How do you know the QMS is working? How can you be sure?What are the important takeaways from today's session?Listen to this discussion and see if you are compliant with the new QMSR. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we'll see if your ideas/inquiries/suggestions align with a future episode.Send us Fan Mail For more medtech news and information, visit https://www.mpomag.com.
The decline of enjoyment in today's air travel experience, special TSA treatment for Congress members, consolidating ATC functions, TRACON evacuations, Artemis II, Part 141 training organizations, and aerial refueling. Also, Av-Con 2026, Spacewoman documentary, “souls onboard,” and EAS. Aviation News ‘The alarm bells are going off': Air travel hits new lows Recent events have made commercial air travel a difficult proposition for many air travelers. We see increasing fuel costs and increasing ticket prices, long lines at some security checkpoints, TSA workers absent, recent accidents, air traffic controller shortages, equipment malfunctions, and more. The U.S. Travel Association's senior vice president of government relations, Erik Hansen, said of passengers, “What they're seeing is chaos, and what they're seeing is a system that doesn't work.” Delta suspends special congressional services amid shutdown In a statement to The Hill, Delta said, “Due to the impact on resources from the longstanding government shutdown, Delta will temporarily suspend specialty services to members of Congress flying Delta. Next to safety, Delta's no. 1 priority is taking care of our people and customers, which has become increasingly difficult in the current environment.” Those services have included airport escorts and red coat services. Senate passes measure prohibiting preferential airport screening for lawmakers Just days before the Delta action, the U.S. Senate unanimously approved a proposal to end the special treatment members of Congress get at airports. That included permitting members of Congress to speed through or skip security screening checkpoints. To become law, the House would have to pass the bill, and the President would have to sign it. LaGuardia controller staffing may have violated procedures on night of collision, document shows On March 22, 2026, an Air Canada jet landing at LaGuardia struck a fire truck, killing both pilots. LaGuardia tower’s standard operating procedures specify that a controller cannot perform both air and ground duties. The NTSB is investigating the roles of the controllers at the time of the crash. A 2023 rule in the LaGuardia Tower Standard Operating Procedures states, “Positions at LaGuardia Tower are not to be consolidated to one position prior to midnight local time or 90 minutes after the start of the shift, whichever is later.” Those familiar with the matter said the rule remained in effect in 2026. D.C.-area ATC evacuations followed 2025 smoke event which injured controllers On March 13, 2026, FAA operations were disrupted after Potomac Terminal Radar Approach Control (TRACON) reported a strong smell. Fire responders investigated, and the source was identified as an overheated circuit board. That incident caused a ground stop lasting a little over two hours, affecting DCA, IAD, BWI, and nearby airports. On March 27, 2026, the TRACON was evacuated again after another strong chemical smell, reportedly originating from an overheated battery backup or other electrical component in the break room/IT area. That second evacuation also triggered ground stops and significant delays across the region. A similar event occurred in April 2025, when smoke entered the Potomac TRACON control room. That incident did not lead to an evacuation, but did leave multiple controllers with health issues severe enough to affect their medical certificates. Artemis II Headed for the Moon The Artemis II Mission flew four astronauts around the moon before returning them to Earth. The planned 10-day test flight is the first time since Apollo 17 in 1972 that humans have departed Earth orbit. NASA's SLS (Space Launch System) rocket and Orion spacecraft lifted off from Launch Pad 39B at the agency's Kennedy Space Center in Florida at 6:35 p.m. EDT on April 1, 2026. The Artemis III mission will launch a crew in the Orion spacecraft atop the SLS rocket to test rendezvous and docking capabilities between Orion and commercial spacecraft (SpaceX and Blue Origin) needed to land astronauts on the Moon. NASA will announce specifics on the Artemis III mission design and crew closer to the 2027 launch. Artemis IV astronauts will travel to lunar orbit, where two crew members will descend to the surface and spend approximately a week near the Moon’s South Pole conducting new science before returning to lunar orbit to rejoin their crew for the journey back to Earth. Report Calls for Major Flight Training Changes The FAA has released a 471-page report by the National Flight Training Alliance (NFTA) titled A Comprehensive Modernization of Pilot Training Conducted by 14 CFR Part 141 Training Organizations, which states: “The goal of this modernization effort is unambiguous: to develop a robust certification and regulatory framework under 14 CFR Part 141 that stands alone as the preeminent accreditation and method by which aviators are trained throughout the world. Under this new framework, achieving FAA certification would represent the highest standard of training excellence available anywhere negating the need for further accreditation or external oversight. The American flight training system would, in this vision, stand alone already.“ The key recommendations include: Establishing a dedicated Central Management Office responsible for all Part 141 pilot school initial certification and ongoing certificate management. Establishing both Safety Management Systems and Quality Management Systems within the Part 141 training environment. Reforming how the FAA manages and oversees certificated pilot schools. Developing industry consensus standards as an alternate means of compliance with Part 141 regulations. Reforming the Part 141 examining authority framework. Expanding Flight Simulation Training Device (FSTD) and Technology Credit and Usage. Modernizing training course appendices. Replacing Provisional Pilot School with Registered Pilot School. A-10 Warthog Being Tested With Aerial Refueling Probe Bolted Onto Its Nose A test A-10 has been flown for the first time with a refueling probe replacing its normal aerial refueling receptacle. The A-10 successfully connected to the aerial refueling drogue of a C-130. The Air Force uses a flying boom system, while the Navy uses a probe-and-drogue system. Mentioned The “Spacewoman” documentary about Eileen Collins, the first woman Shuttle pilot. Journey is the Reward / Airplane Geeks Meet-Up, Sunday, May 17, 2026, 4:00 PM at Charlie's Pizza, Restaurant and Pub (1980 Rt. 37, Manchester Township, NJ 08759). Visiting the Av-Con 2026 in Atlanta – Held April 4, 2026, at the Delta Flight Museum. Av-Con is described as “the world's first convention built for aviation fans by aviation creators.” Souls On Board Hosts this Episode Max Flight, our Main(e) Man Micah, and Rob Mark.
Ho Nieh, Chairman of the U.S. Nuclear Regulatory Commission, visited the Atomic Show for a wide ranging discussion about the agency, its role in enabling the safe use of nuclear energy, the importance of its mission to the energy future of the United States, the benefits of having organization led by a five person commission of decision makers and the ways in which the NRC is evolving to better serve the needs of the United States in an era of rapid technological change. Chairman Nieh’s father worked as a nuclear qualified welder. His experiences during spring and fall outages were part of the inspiration for Nieh’s decision to pursue a career in nuclear engineering. He studied marine engineering at the U. S. Merchant Marine Academy. That major was the closest thing to a nuclear engineering program available at the sometimes overlooked 5th service academy. Chairman Nieh at Aalo Atomics Pilot factory – March 2026 (Used with permission from USNRC) Aside: (Everyone remembers the Military Academy, the Naval Academy (my personal favorite) and the Air Force Academy. Many know about the Coast Guard Academy. It’s less common to recall that the Merchant Marines play a vital role in the defense establishment and that they have their own service academy. End Aside. Chairman Nieh told us about how he started his nuclear career as an instructor/operator at the S8G prototype at the Navy’s prototype site in West Milton, NY. He spent more than 4 years as a shift worker at the facility, likely having contact with 16 or more classes of trainees in the Navy’s Nuclear Power Program. After four plus years on rotating shifts, he was open to a suggestion from a former colleague to apply for a job as a resident inspector with the NRC. (Chairman Nieh is the first NRC Commissioner to have served as a resident inspector.) At his service academy, Nieh was trained to seek roles of increasing responsibility where he could put his leadership training to its most effective use. His career on the NRC staff contains abundant evidence of choices made to deepen and broaden his capabilities as a leader in a complex and vital field. Chairman Nieh described his appreciation of the skills, work ethic and depth of experience of his four fellow commissioners. It’s almost de rigueur for NRC commissioners to praise the collegiality of their Commission, but it sounded like he was describing an especially useful version of that descriptor is applicable to the current group. We spoke about the agency’s evolving understanding of its role in enabling the safe use of nuclear energy and its growing understanding that the guiding language on that topic has always been included in Article 1 of the Atomic Energy Act. He acknowledged that there have been past leaders on the Commission and on the staff who felt that enabling was too “promotional” and wasn’t part of the NRC’s mission. We spoke about the NRC’s very recent release of 10 CFR Part 53, the long-anticipated, new licensing framework whose creation was directed by the Nuclear Energy Innovation and Modernization Act of 2019. Though analysis of the final, 701-page rule is still in progress, the early returns show that it has generally succeeded in becoming a risk-informed, performance-based, technology-inclusive framework for designing and licensing new nuclear reactors. Though the rule is still under review and the draft has not yet been made public, the Chairman Nieh described how NRC is close to completing another assigned task, this one directed by Executive Order 14300. The Commission is reconsidering the use of the linear, no threshold (LNT) radiation protection model and the associated regulatory requirement to take action to keep radiation doses as low as reasonably achievable (ALARA), even when the doses involved are already many multiples below the regulatory limit. Chairman Nieh emphasized that the agency is maintaining its historic independence and that there are no external forces that are going to detract it from its role in maintaining safety. He also describes how keeping reactors safe does not mean preventing them from being built and operated. The nation needs abundant, affordable, reliable, clean power. It needs nuclear plants that can be built on time and within budget and a regulator that will not inhibit the accomplishment of the goal for safe and abundant nuclear energy. I think you will enjoy the show.
What if the biggest barrier to better behavioral health outcomes isn't access to data, but how carefully we protect it? In this episode, Helen Oscislawski, a healthcare data privacy and interoperability attorney, explains that behavioral health and substance use data require stricter privacy protections due to their sensitivity and history of misuse, and are governed by laws such as 42 CFR Part 2. She highlights how modern interoperability and AI create new opportunities to share data more precisely, but also introduce greater legal and ethical risks. Updated regulations now allow more flexible data sharing to improve care coordination, while introducing stronger enforcement and penalties for non-compliance. She emphasizes that success depends on “privacy by design,” strong governance, and a deep understanding of consent frameworks to preserve patient trust. Tune in to learn how smarter consent, stronger privacy frameworks, and better governance can unlock safer, more effective data sharing in behavioral health! Resources: Connect with and follow Helen Oscislawski on LinkedIn. Follow Attorneys Oscislawski LLC on LinkedIn and visit their website. Check out the Legal HIE website.
In this episode, host Etienne Nichols speaks directly to professionals in industries like automotive, aerospace, and manufacturing who are looking to transition into MedTech. Drawing from his own experience moving from aerospace to medical devices, Etienne demystifies the industry's high barriers to entry and explains why your existing skills are more valuable than you might think.The conversation centers on the "three doors" of entry: Quality, Regulatory Affairs, and Product Development. While each path has unique requirements, Etienne emphasizes that foundational skills like project management, root cause analysis, and technical writing are the true drivers of success. He also clarifies the shift in mindset required to work in a highly regulated environment where "move fast and break things" is replaced by rigorous documentation and risk-management protocols.Finally, Etienne provides a five-step roadmap for career switchers, ranging from learning the regulatory language to networking with intention. He concludes with a powerful reminder that technical competence is only the entry fee; long-term career growth in MedTech requires mastering the "layer above"—communication, visibility, and storytelling.Key Timestamps00:00 – The "career switcher" mindset: Why MedTech is a stable and fulfilling choice.03:15 – The Regulatory Universe: Comparing IATF 16949 and AS9100 to ISO 13485 and 21 CFR Part 820.06:42 – Door #1: Quality. Roles in quality systems, auditing, and why "document control is document control."10:15 – Door #2: Regulatory Affairs. How to break into the most specialized sector of MedTech.13:50 – Door #3: Product Development. Designing with guardrails and the importance of design controls.17:30 – Transferable Skills: Project management (PMP), root cause analysis, and process validation (IQ/OQ/PQ).22:10 – What doesn't transfer: The reality of MedTech speed and the death of "good enough" thinking.26:45 – 5 Steps to making the jump: Language, credentials, networking, targeting, and honesty.32:15 – The Layer Above Competence: Navigating workplace politics and the "Workplace Poker" philosophy.Quotes"In automotive, a quality failure means a recall. In MedTech, a quality failure could mean that somebody gets hurt. It changes the math." - Etienne Nichols"If we didn't document it, it didn't happen. Getting used to that level of rigor is one of the biggest adjustments career switchers face." - Etienne NicholsTakeawaysFocus on the QMS Foundations: If you are coming from a quality background, prioritize learning ISO 13485 and ISO 14971 (Risk Management). These are the global languages of MedTech quality.Document Everything: Successful MedTech professionals must transition from "casual" documentation (emails/memos) to formal Design Controls, where every input has a verified output.Leverage Cross-Industry Skills: Lean on your experience in Six Sigma, Root Cause Analysis (RCA), and Process Validation; the statistics are the same, even if the regulatory "overlay" is different.Target Mid-Sized Companies: While big names like J&J are attractive, medium-sized companies or Contract Manufacturers (CMOs) often provide better mentorship and a faster learning curve for newcomers.Master "The Layer Above": Technical skills get you hired, but visibility and the ability to communicate technical risks to non-technical stakeholders are what lead to promotions.MedTech 101 SectionIQ/OQ/PQ (Process Validation) Think of this like baking a signature cake for a high-stakes competition.IQ (Installation Qualification): Did you plug the oven in correctly and is it the right model? (Is the equipment installed right?)OQ (Operational Qualification): Does the oven actually hit 350°F when you turn the dial, and does it stay there? (Does it work at its limits?)PQ (Performance Qualification): Can you bake ten perfect cakes in a row using your actual ingredients and staff? (Does the process consistently produce a good product?)ReferencesISO 13485:2016: The international standard for medical device quality management systems.21 CFR Part 820 / QMSR: The FDA's requirements for medical device manufacturers.RAPS (Regulatory Affairs Professionals Society): Recommended for Regulatory Affairs Certification (RAC).Workplace Poker by Dan Rust: A recommended read for navigating office politics and career growth.Etienne Nichols' LinkedIn: Connect with Etienne hereSponsorsThis episode is brought to you by Greenlight Guru. If you are transitioning into MedTech, you'll quickly realize that documentation is everything. Greenlight Guru offers the only dedicated Quality Management System (QMS) and Electronic Data Capture (EDC) solutions designed specifically for the medical device industry. Whether you are navigating your first clinical trial or scaling a quality system from scratch, Greenlight Guru helps you move faster while staying compliant.Feedback Call-to-ActionWe want to hear your story! Are you trying to make the jump into MedTech, or have you recently made the switch? Send your questions, topic suggestions, or feedback to podcast@greenlight.guru. Etienne reads every email and provides personalized responses to help you on your journey. We'd also love for you to leave a review on your favorite podcast platform!
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 discuss HHS's new model Notice of Privacy Practice for Part 2 programs, what has changed, and what that means for your practice. We cover: The Part 2 Final Rule from 2024 Why the Feb. 16th enforcement deadline has been so confusing The model Part 2 NPP and Patient Notice from HHS, and the function of each document Who is considered a lawful holder and what that means Whether you need to switch to the HHS templates What to do if you already used our decision guide and resources ahead of the deadline Listen here: https://personcenteredtech.com/group/podcast/ For more, visit our website. Resources Updated HHS Model Notice of Privacy Practices Model Part 2 Patient Notice HHS Part 2 Final Rule Fact Sheet PCT decision guide and sample language resource Additional PCT Resources Episode 605: 42 CFR Part 2, HIPAA NPPs, and the February 16 Deadline: What Actually Needs to Change 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
Updates on the DCA midair collision, JetBlue software glitch, Air India B787 fuel control switch, injuries on United B777 flight, and Toronto CRJ-900 rollover. Also, the AA CEO’s message to employees, DOT mandate to purge DEI, Portland International Jetport passenger volume, Elliott Management and Southwest, and flight attendant carry-on bags. Plus, our first report from the Singapore Airshow. Guest Air Accident Updates We look at some air accident and incident updates in the press: NTSB Chair Slams FAA for Ignoring Repeated Warnings, Says Midair Collision Was Preventable In this C-Span video, NTSB Chair Jennifer Homendy slams the FAA, saying that it let its guard down and ignored repeated warnings that ultimately led to the deadly midair collision near Washington Reagan National Airport on January 29, 2025, that killed 67 people. “We should be angry, because for years no one listened. This was preventable. This was 100 percent preventable,” Homendy says. Passengers on JetBlue Plane That Plummeted When Flight Computer “Glitched Out” Sue Airbus for Negligence The JetBlue A320 experienced a sudden “uncommanded loss of altitude,” initially attributed to a software glitch that Airbus believed could result from intense solar radiation. This led to an emergency worldwide recall in November 2025, with an estimated 6,000 A320-series aircraft affected. Three passengers on that flight are now suing Airbus for allowing an “unreasonably dangerous” glitch in the system to go unchecked. Those passengers question the solar flare explanation and claim that JetBlue was aware of a recurring issue with the Elevator and Aileron Computer (ELAC) system. No defect found in switch of jet grounded by Air India – regulator Pilots on an Air India B787-8 noticed that during engine start, the fuel control switch did not “remain positively latched in the run position when light vertical pressure was applied”. This happened twice. The third time, the switch operated normally. The Directorate General of Civil Aviation (DGCA) said that when the switches were operated according to Boeing’s recommended procedure, they were found to be “satisfactory”, staying at run instead of moving to cut-off. The DGCA reported that, when incorrectly handled, the switch would “move easily from run to cut-off”. See also, Pilot alert prompts Air India checks on all Boeing 787 fuel control switchesby Rachel Chitra. Three United Airlines Flight Attendants Seriously Injured After Air Traffic Control Failed To Alert Pilots Of Turbulence The NTSB has released its final report on the February 10, 2024, incident where a United Airlines 777-200 experienced a sudden drop, seriously injuring three flight attendants and throwing several passengers and an unsecured baby into the ceiling. The NTSB concluded that a contributing factor was air traffic controllers’ failure to alert the pilots of turbulence in the area. TSB Canada Releases Update on 2025 Toronto CRJ-900 Crash Investigation Photo Credit: TSB Canada. The accident occurred at Toronto/Lester B. Pearson International Airport (CYYZ) on February 17, 2025, when the CRJ-900 regional jet attempted to land and struck the runway hard, causing the right wing and tail section to separate from the fuselage. The plane flipped upside down and slid to a stop. The wreckage was transported to a hangar while the right wing, landing gear, wing box structure, and related parts were taken to the Transportation Safety Board of Canada (TSB) Engineering Laboratory in Ottawa for testing. The metallurgical analysis of the wing and landing-gear fractures is now being examined. Recordings from the flight data recorder, cockpit voice recorder, quick access recorder (QAR), and the enhanced ground proximity warning system have been examined. Data from prior flights on the same aircraft were also compared to the accident flight for context. Evidence was collected from NAV CANADA's Toronto surface movement guidance system and the airport's closed-circuit television footage. A full meteorological review, including wind data and soundings, has also been finalized to understand weather conditions at the time. Simulator sessions have been run. The full preliminary report is available here. Aviation News Under Pressure American Airlines CEO Robert Isom Tells Staff That Everything Will Be Alright In New Video Message In a new video message to staffers, American Airlines chief executive Robert Isom says, “As we look forward to 2026, it's with a lot of excitement and confidence. I know we're going to do better financially and operationally. We have a plan to be solidly profitable this year, which will mean good things for our customers, our shareholders, and all of you.” Isom articulated strategies concerning the customer experience, hub facility investments, maximizing the power of the AA network and fleet, new routes, new frontline team members, new aircraft, AAdvantage program changes, and doing a better job selling the AA product. Trump's U.S. Transportation Secretary Sean P. Duffy Doubles Down on Purging DEI From Our Skies, Calls on Airlines to Affirm Pilot Hiring is Merit-Based The FAA is issuing a new mandatory “Operations Specification” (OpSpec) requiring all commercial airlines to commit to merit-based hiring for pilots formally. The mandate (New Mandatory OpSpec A134, Merit-Based Pilot Hiring, for Certificate Holders Conducting Operations Under 14 CFR Part 121 [PDF]) is effective February 13, 2026. U.S. Transportation Secretary Sean P. Duffy said, “When families board their aircraft, they should fly with confidence knowing the pilot behind the controls is the best of the best. The American people don't care what their pilot looks like or their gender—they just care that they are most qualified man or woman for the job. Safety drives everything we do, and this commonsense measure will increase transparency between passengers and airlines.” ALPA Statement on Pilot Training and Qualification Standards Capt. Jason Ambrosi, president of the Air Line Pilots Association, Int’l (ALPA), issued a statement that included: “All ALPA pilots are trained and evaluated to the same uncompromising standard regardless of race, gender, or background. A pilot’s identity has no bearing on their ability to safely operate an aircraft. What matters is training, experience, and qualification — and on that front, there are no shortcuts and no compromises. “At ALPA, our work to advance aviation safety never stops, and as always, ALPA airline pilots remain ready to safely transport passengers and cargo to their destinations. Safety is, and always will be, our number one priority.” Portland International Jetport logs busiest year in its history The Portland International Jetport had a record year in 2025, with more than 2.59 million passengers traveling through the airport. The previous record was 2.44 million in 2024. The Jetport says it became the first airport in New England to surpass its pre-pandemic passenger levels in 2023. Southwest Airlines Turns a Corner as Activist Investor Elliott Walks Away Elliott Management, an activist investor, began to acquire shares of Southwest stock in mid-2024. It bought enough shares to gain board representation and dictate the Airline's strategic and financial changes. As a result, we saw paid assigned seating, baggage fees, expiring travel credits, and adjustments to its Rapid Rewards program. Southwest also looked at asset sales and balance sheet strategies to fund share buybacks. But in late 2025, Elliott began reducing its stake, and by early February 2026, its ownership dropped to about 9 percent. Two Elliott representatives have resigned from the board at Southwest. Southwest Airlines Now Faces a Flight Attendant Backlash As Hand Luggage Woes Grow Southwest moved a dedicated overhead bin for crew members to the back of the plane, and flight attendants are not happy. Passengers sitting at the front of the plane who have paid more or have elite status find that bin space is an issue. Singapore Airshow 2026 Brian Coleman interviewed several people at the Singapore Airshow. In this episode, he talks with Dan McQuestin, the Bell Country Manager in Australia. Mentioned “How LiveATC Went Live” by Rob Mark in the February 2026 issue of AIN Online. Hosts this Episode Max Flight, our Main(e) Man Micah, Rob Mark, and Erin Applebaum.
OA1236 - Elections grab bag! Election news has been accumulating, so Jenessa helps us get caught up on what's going on. Who's winning elections? What's going on with redistricting? Heard something confusing about the mail? Trump back on his bullshit again? Good news, mixed news, debunking alleged bad news, bad news with plans for how to turn things around; we've got it all. Updates since we recorded: The SAVE America Act passed the House. Also the affidavit for the warrant in Georgia was unsealed. We'll talk about it soon, but the short version is these people really still believe in election conspiracy theories. It's gross. We'll survive. John Hanna & Julie Carr Smyth (Feb. 1, 2026). Texas stunner: Democrat Taylor Rehmet flips Republican state Senate district Trump won by 17 points, Associated Press. Amy Howe (Feb. 4, 2026). Supreme Court allows California to use congressional map benefitting Democrats, SCOTUSBlog. Tangipa v. Newsom (docket and SCOTUSBlog coverage), SCOTUSBlog. Abbott v. League of United Latin American Citizens (docket and SCOTUSBlog coverage), SCOTUSBlog. H.R.7296 - SAVE America Act, Congress.gov. H.R.7300 - Make Elections Great Again Act. Congress.gov. Domestic Mail Manual 608.11 Domestic Mail Manual amendment explanation (Nov. 24, 2025). Postmarks and Postal Possession, Federal Register. 39 CFR Part 111 Dan Mooney, What Is RTO? Why Do We Have It?, National Association of Postal Supervisors (Aug. 19, 2025) Regional Transportation Optimization (RTO) initiative. (Feb. 2, 2025). Service Standards for Market-Dominant Mail Products, Federal Register. 39 CFR Part 121 Track Your Ballot or Ballot Application, Vote.org. 2 U.S.C. § 7 - Time of election (Dec. 24, 2025). Table 11: Receipt and Postmark Deadlines for Absentee/Mail Ballots, National Conference of State Legislatures. Evan Lee (Jan. 15, 2026) Court holds that all candidates can challenge rules governing vote counting in elections, SCOTUSBlog. Bost v. Illinois State Board of Elections, 607 U.S. __ (2026). Bost v. Illinois State Board of Elections (docket and SCOTUSBlog coverage), SCOTUSBlog. Amy Howe (Nov. 10, 2025). Justices agree to decide major election law case, SCOTUSBlog. Watson v. Republican National Committee (Election Law) (docket and SCOTUSBlog coverage), SCOTUSBlog. Check out the OA Linktree for all the places to go and things to do!
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 what's actually necessary when updating your Notice of Privacy Practices due to Part 2. We discuss: The confusion around updating NPPs without an updated model from HHS A quick refresher on Part 2 Who is considered a lawful holder under Part 2 Next steps for updating your NPP if you are a Part 2 program or lawful holder Our free resource on updating your NPP before the 2/16 enforcement deadline Listen here: https://personcenteredtech.com/group/podcast/ For more, visit our website. PCT Resources PCT Free Resource: 42 CFR Part 2 & HIPAA Notices of Privacy Practices: A Decision Guide and Sample Language for Covered Entities a practical resource designed to help HIPAA-covered practices determine whether the updated 42 CFR Part 2 rules apply to them — and, if so, what belongs in their Notice of Privacy Practices. The guide includes a clear decision flow, plain-language explanations of Part 2 program vs. lawful holder obligations, and sample NPP language tailored to each category. It was created to fill the gap left by the absence of an updated HHS model NPP following the 2024 Part 2 Final Rule. Resources HHS Fact Sheet on the 42 CFR Part 2 Final Rule this HHS Fact Sheet summarizes the 2024 Final Rule updating 42 CFR Part 2, including new consent provisions, redisclosure alignment with HIPAA, enforcement changes, and the February 16, 2026 compliance deadline. It provides high-level regulatory context for healthcare organizations handling substance use disorder records. JD Supra Article: 42 CFR Part 2 and Privacy Rule Compliance: Action Required by February 16, 2026 This JD Supra article from Snell & Wilmer outlines the compliance steps healthcare organizations must take in response to the 2024 Final Rule updating 42 CFR Part 2. It explains which entities are required to update their Notices of Privacy Practices by February 16, 2026, including both Part 2 programs and HIPAA-covered entities that receive or maintain Part 2-protected records. The article highlights required NPP updates, enforcement risks, and the importance of aligning privacy notices with the amended regulations.
The FDA's transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks the most significant update to 21 CFR Part 820 in nearly two decades. But for medical device manufacturers, this is more than just a regulatory rewrite—it is a shift toward global harmonization that requires immediate strategic action.In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo, Senior Director of Quality at Kymanox, to unpack the practical realities of the QMSR rollout. With over 30 years of experience in quality systems and design controls, David explains why "being ISO 1345 certified" isn't a free pass for compliance and how to turn this regulatory hurdle into a long-term business advantage.Topics Include:The "Why" Behind QMSR: Understanding the FDA's push to harmonize with ISO 1345:2016 and what it means for global market access.Risk Management Evolution: Moving beyond product risk (ISO 14971) to apply risk-based decision-making across the entire quality system, from CAPAs to training.The Certification Myth: Why your existing ISO 1345 certificate won't stop the FDA from auditing your facility.Supplier Controls: How to update supplier files to be "living documents" that satisfy the new monitoring requirements.A 5-Step Implementation Roadmap: A proven strategy to assess gaps, remediate SOPs, and ensure your team is ready before the deadline.Whether you are a VP of Quality or a Regulatory Affairs specialist, this conversation offers a clear, science-forward path to navigating the new landscape of medtech compliance.
The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere streamlining, the change is mandatory, with an effective and fully enforceable date of February 2, 2026. The episode addresses industry complacency and details critical steps manufacturers must take immediately.The episode debunks the myth that familiar quality documents like the DHF, DMR, and DHR are being eliminated. While the specific terms are removed from the regulation's language, their substance is retained and mapped to new, ISO-aligned conceptual requirements: the Device Master Record (DMR) becomes the Medical Device File (MDF), the Design History File (DHF) becomes the Design and Development File (DDP), and the Device History Record (DHR) is captured in the Batch or Lot Record. The host emphasizes that internal documents can retain the old terminology, provided a clear regulatory mapping is established.Crucially, compliance requires more than just an ISO 13485 certificate. Two major philosophical shifts must be addressed: the explicit requirement for integrating lifecycle risk management as the DNA of the entire QMS, and the loss of the audit privilege, which makes internal audit reports, supplier audit reports, and management review records inspectable regulatory evidence. Furthermore, manufacturers must comply with retained, US-specific requirements under the QMSR's prevalence rule, especially concerning mandatory record content (§ 820.35) and specific labeling and packaging controls (§ 820.45).Key Timestamps[0:50] QMSR: The biggest shakeup to US quality requirements since 1996.[2:00] Effective Date: February 2, 2026—the clock is ticking.[2:42] The Goal: Harmonization with ISO 13485:2016 to reduce redundancy for global manufacturers.[3:50] Myth 1 Busted: The FDA is eliminating the DHF, DMR, and DHR (Documentation Dissolution).[5:10] Terminology Shift: DMR > Medical Device File (MDF, ISO 13485 Clause 4.2.3).[6:30] Terminology Shift: DHF > Design and Development File (DDP, ISO 13485 Clause 7.3.10).[7:40] Terminology Shift: DHR > Batch or Lot Record (ISO 13485 Clause 7.5.1).[8:40] The Practical Takeaway: Internal naming is fine, but regulatory mapping is mandatory.[10:30] Critical Shift 1: Risk Management is the DNA of the QMS—Explicitly required across all clauses.[13:00] Critical Shift 2: Loss of the Audit Privilege—Internal audit and management review records are now inspectable.[17:00] Critical Shift 3: Retained FDA Specifications (Prevalence Rule).
Dr. Yuan Li, Director of Medical Business at DQS and a former medical device auditor with deep expertise across orthopaedic manufacturing and regulatory systems.In this episode, we discuss the sweeping regulatory transition coming to the U.S. with the introduction of the Quality Management System Regulation (QMSR), which formally aligns 21 CFR Part 820 with ISO 13485. Yuan unpacks what this shift means for U.S.-based manufacturers, why FDA is phasing out the QSR audit model and why contract manufacturers and software-based device firms are particularly vulnerable if they delay planning.We also explore the growing use of AI in QMS platforms, the pitfalls of template-driven compliance, and why “regulatory fatigue” is no excuse when patients' lives are at stake. From post-market surveillance strategies to paperless QMS migrations and the validation grey zone, Yuan offers pragmatic, deeply informed advice for those navigating FDA audits, ISO certification and international expansionTimestamps[00:02:36] Why QMSR is a Big Deal for U.S. Manufacturers[00:04:09] Key Differences Between 21 CFR 820 and ISO 13485[00:05:09] Why Companies Wait Too Long to Comply[00:07:19] Impact on Contract Manufacturers and Supply Chains[00:08:36] Do You Really Need ISO 13485 Certification?[00:10:18] AI-Generated QMS Systems: Useful or Risky?[00:11:52] Most Memorable Audit Story: Iterative Design Gone Wrong[00:14:46] How to Spot Proactive vs Reactive Post-Market Surveillance[00:17:03] Why Software Companies Struggle with The Regulatory Mindset[00:20:57] What Validation Really Means Under ISO 13485Connect with Yuan - https://www.linkedin.com/in/yuan-li-phd-3bb14013/Learn more about DQS - https://www.dqsglobal.com/en/Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwalSubscribe to the Podcast
Doug Bain, founder and consulting partner of ClinFlo, discusses his proposed regulatory blueprint for digital trials in the latest episode of The Scope of Things podcast. With host Deborah Borfitz, Bain delves into his strategy for turning 21 CFR Part 11 into a more practical regulation that streamlines rather than bogs down clinical trials, what would qualify someone to take on the role as a trusted third party (and what makes them trustworthy), and the new FDA administration's modernization plan aligns—or squares—with his ideas. Plus, the latest news on a tool for detecting fraud and sampling bias in decentralized trials, technology for identifying potentially dangerous drugs before trials start, a novel women's health and menopause initiative, a regenerative therapy for spinal cord injury, and a new oral treatment for preventing dementia. Show Notes : News Roundup Data collection tools for decentralized trials MyTrials platform study in the Journal of Clinical and Translational Science Real-time data integration tool Press release on the Mount Sinai website Drug toxicity prediction Article in EbioMedicine Tufts Women's Health and Menopause Initiative News from Tufts University Regenerative therapy for spinal cord injury Article in Nature Oral treatment for preventing dementia Press release from Aarhus University Guest Doug Bain, founder and consulting partner of UK-based ClinFlo The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider's look at clinical research today.
By early 2026, substance use disorder (SUD) providers, health plans, clinicians, health information exchanges (HIEs), and vendors must meet new federal privacy standards for SUD treatment records or face Health Insurance Portability and Accountability Act (HIPAA)-level enforcement and penalties. On this episode, Epstein Becker Green attorneys Lisa Pierce Reisz, David Shillcutt, and Laura DePonio join Nichole Sweeney, General Counsel and Chief Privacy Officer at CRISP, to break down the 42 CFR Part 2 final rule: what's changing, what's staying the same, and what organizations often miss. The group explains how the final rule aligns with (but does not replace) HIPAA, why patient consent remains central, and what new operational risks are emerging. Key Takeaways: Adoption of HIPAA Penalties: Part 2 now adopts HIPAA's enforcement and penalty structure. Operational Readiness Challenges: Operational readiness, not technology, is the biggest challenge. Expanded Compliance Duties: Payors and HIEs face major shifts in data access and compliance duties. Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc91. Subscribe for email notifications: https://www.ebglaw.com/subscribe. Visit: http://diagnosinghealthcare.com. This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
If you have a loan, then the latest episode of Making Cents of Money is for you! Learn how loan servicers play a key role in borrowers' financial lives and more! Show Notes: Government and Agency Reports: • Consumer Financial Protection Bureau. (2024, Apr 3). What happens if my loan servicer changes? Retrieved from https://www.consumerfinance.gov/ask-cfpb/what-happens-if-the-company-that-i-send-my-mortgage-payments-to-changes-en-215/ • U.S. Department of Education. (2023). Loan servicing information. Retrieved from https://studentaid.gov Laws and Regulations: • Real Estate Settlement Procedures Act (RESPA), 12 U.S.C. §§ 2601-2617. • Consumer Financial Protection Bureau. (n.d.). Real Estate Settlement Procedures Act (RESPA). Retrieved from https://www.consumerfinance.gov/compliance/compliance-resources/mortgage-resources/real-estate-settlement-procedures-act/ • Truth in Lending Act (TILA), 15 U.S.C. §§ 1601-1667f. • Consumer Financial Protection Bureau. (n.d.). 12 CFR Part 1026 – Truth in Lending (Regulation Z). Retrieved from https://www.consumerfinance.gov/rules-policy/regulations/1026/ Web Resources: • Federal Trade Commission. (n.d.). Your rights when paying your mortgage. Retrieved from https://consumer.ftc.gov/articles/your-rights-when-paying-your-mortgage • Federal Housing Finance Agency. (n.d.). About Fannie Mae & Freddie Mac. Retrieved from https://www.fhfa.gov/about/fannie-mae-freddie-mac Student Loans: • Federal Student Aid. (n.d.). Who's my student loan servicer? Retrieved from https://studentaid.gov/manage-loans/repayment/servicers • University of Illinois System Student Money Management Center (n.d.). Student loans. Retrieved from https://www.studentmoney.uillinois.edu/learn/studentloans • Student Loan Management #GetSavvy webinar recording on YouTube: https://youtu.be/_9duc7kvTqg?feature=shared
In this episode, host Etienne Nichols speaks with Greenlight Guru's Christine Wilbert, an expert in Electronic Data Capture (EDC) systems for Clinical Research Organizations (CROs). They discuss the critical factors CROs must consider when selecting an EDC solution. Christine highlights that the biggest mistake is a lack of due diligence and not planning for future needs beyond a single study. She emphasizes the importance of looking for a solution that can scale with a company's growth, from pilot studies to pivotal trials, and warns against hidden costs and inadequate post-sales support.The conversation delves into what truly matters in an EDC platform, such as intuitive design, speed of implementation, and the ability to handle repeatable processes. Christine shares that while some vendors may offer "bells and whistles," the core value lies in a lean, efficient system tailored to medical device trials. They also touch on the importance of involving all stakeholders, including site users like clinicians and healthcare professionals, to ensure system adoption and maintain data integrity.Finally, the discussion explores how an EDC system can help CROs win more business. Christine explains that having a scalable, pre-validated solution and a vendor that actively supports business development can be a significant advantage. They also cover the essential compliance features for global trials, such as FDA 21 CFR Part 11 and ISO 14155, and the growing role of hybrid and decentralized trials. Christine's final advice to CROs is to "do your due diligence" and select a solution that's a true partner for long-term success.Key Timestamps00:02:39 - Biggest mistakes CROs make when choosing an EDC.00:03:00 - The importance of future planning and scalability.00:04:40 - The value of post-sales support and avoiding hidden fees.00:05:31 - Essential features versus "vendor noise" and unnecessary bells and whistles.00:08:11 - The analogy of a "battleship" vs. a "ninja" in problem-solving.00:09:13 - Identifying key stakeholders for successful EDC implementation.00:11:17 - Challenges and strategies for engaging healthcare professionals.00:13:31 - When to start looking for an EDC solution and the typical timeline.00:15:44 - The onboarding process and what successful companies do in the first few months.00:18:39 - How CROs can use an EDC solution to win more business.00:20:52 - Global compliance considerations (FDA, EU MDR) for EDC platforms.00:23:36 - Features CROs think they need but don't (e.g., QMS integration).00:26:03 - Adapting to hybrid and decentralized trials.00:27:22 - The key takeaway: do your due diligence and seek a true partner.Quotes"I would say the biggest issue is lack of due diligence... they're not necessarily thinking down the line, 'how is this going to scale with this specific company that they're working with?'""The bitterness of poor quality remains long after the sweetness of low price is forgotten."TakeawaysPrioritize Scalability and Long-Term Planning: Don't choose an EDC solution just for a single pilot study. Evaluate whether the platform can handle the complexity and size of pivotal and post-market studies to avoid costly transitions in the future.Look for True Partnership, Not Just a Vendor: A successful relationship with an EDC provider goes beyond the initial sale. Seek a vendor with strong post-sales support and a willingness to collaborate on...
If you've ever wondered what a combination product is—or how to explain it—this video breaks it down clearly and simply. This is a non-technical, high-level explanation of what a combination product is. It's meant for anyone who works in or around pharma, medtech, or biotech and wants a clear, shareable reference—without getting into detailed regulatory definitions or region-specific nuances.I'm Subhi Saadeh, and I've spent my career in drug-device combination products. In this short reference video, I walk through:- What defines a combination product- Two key factors: primary mode of action and how components are combined- The difference between drug-led and device-led products- Examples of single-entity, co-packaged, and cross-labeled products00:00 Introduction to Drug Device Combination Products00:31 Defining Combination Products00:54 Philosophical Factors of Combination Products01:10 Drug-Led Combination Products01:51 Device-Led Combination Products02:32 Combination Configurations03:50 Summary and ConclusionAdditional Resources: - 21 CFR Part 4 FDA regulation on Current Good Manufacturing Practice (CGMP) requirements for combination products https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4- FDA Guidance: Current Good Manufacturing Practice Requirements for Combination Productshttps://www.fda.gov/media/90652/download- FDA Combination Products Overview Page https://www.fda.gov/combination-products- 21 CFR Part 3 Regulations on combination product classification and primary mode of action (PMOA) https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-3- EU MDR Article 117 Requirements for drug-device combinations under the European Medical Device Regulation (Regulation (EU) 2017/745) https://health.ec.europa.eu/system/files/2021-10/md_mdr_2017-745_en_0.pdfSubhi 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.
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
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
The Poco a Poco Podcast with the Franciscan Friars of the Renewal
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!
The Poco a Poco Podcast with the Franciscan Friars of the Renewal
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!
The Poco a Poco Podcast with the Franciscan Friars of the Renewal
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
The Poco a Poco Podcast with the Franciscan Friars of the Renewal
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
The Poco a Poco Podcast with the Franciscan Friars of the Renewal
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
The Poco a Poco Podcast with the Franciscan Friars of the Renewal
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!
The Poco a Poco Podcast with the Franciscan Friars of the Renewal
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!
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
The Poco a Poco Podcast with the Franciscan Friars of the Renewal
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!
The Poco a Poco Podcast with the Franciscan Friars of the Renewal
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!
The Poco a Poco Podcast with the Franciscan Friars of the Renewal
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!
The Poco a Poco Podcast with the Franciscan Friars of the Renewal
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!
© 2020-2026 Ivy Podcast Discovery LLC
