show episodes
 
Welcome to the Maryland Risk Management Education Podcast featuring Paul Goeringer, extension legal specialist, Department of Agricultural and Resource Economics (AREC) and a member of the Agriculture Law Education Initiative. Paul will use this podcast to focus on issues related to agricultural law and risk management education. Send podcast ideas to lgoering@umd.edu. Any images you see are by Edwin Remsberg unless otherwise noted.
 
Get the most up-to-minute news and information on ICD-10. Join Chuck Buck and Erica Remer, MD, FACEP, CCDS, every Tuesday as they welcome ICD10monitor contributing editors and special guests to monitor and report on the progress that all healthcare stakeholders are experiencing in their respective implementations of ICD-10. Register to attend live here: https://event.webcasts.com/starthere.jsp?ei=1236510&tp_key=da0e4c0f76
 
Office Hours is a work of passion to share strategies, technology ideas, and real-world stories that inspire governance, risk management, compliance, and audit professionals to live their biggest impact! Our channel is dedicated to delivering the best stories and strategies in developing GRC programs we've seen across 7,000 organizations in 140 countries around the world.
 
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show series
 
Like the inevitable approach of a slow-moving freight train, ICD-11 is on the horizon, heading this way. It’s coming. That’s why we asked Margaret Skurka to join us for the next upcoming edition of Talk-Ten-Tuesdays: to give you an exclusive update on the new code set for America’s health system. Skurka, a member of the National Committee of Vital …
 
This week, Stacey presents the 2021 IVT Awards and interviews the recipients of each award. The awards being presented are Author of the Year for the Journal of GXP Compliance, Author of the Year for the Journal of Validation Technology, Podcast of the Year, Speaker of the Year for Validation Week, Speaker of the Year for Compounding Pharmacy Compl…
 
Today’s episode of The Drive is a rebroadcast of the conversation with Rick Johnson (originally released January 6th, 2020). This episode was one of the most popular discussions to-date and is a prelude to an upcoming follow-up discussion which will be coming out in February 2022 along with the release of Rick’s new book. In this episode, Rick John…
 
The Omnibus COVID-19 Health Care Staff Vaccination Mandates are out! What entities are included under the regulations, and which are excluded? Facilities and physician practices have been doing everything they can to get staff and providers vaccinated, in fear of losing their provider status with Medicare and their funds being interrupted. But what…
 
This week, Stacey and Nuala sit down with Jayet Moon, author of "Foundations in Quality Risk Management" to review some of the key discussion points from his book and share his views on how risk management “is central to the science of prediction and decision-making;” and how “holistic and scientific risk management creates resilient organizations,…
 
In this “Ask Me Anything” (AMA) episode, Peter and Bob discuss all things related to GLP-1 agonists—a class of drugs that are gaining popularity for the treatment of obesity. They cover the discovery of these peptides, their physiology, and what it is they do in their natural state. Next, Peter and Bob break down a recently published study which sh…
 
Is the emergency department (ED) an outpatient CDI priority for your organization? The emergency department is the main source of admissions to a hospital – and the first location patients typically receive care. What should you consider when determining how an outpatient CDI program could support quality patient care, proper payment, and complete …
 
This week, Stacey is joined by Kate Coleman to discuss the essentials for building a culture of quality while achieving customer satisfaction. Across life sciences, teams concur that quality, defined by safe, effective, and compliant products, is a prerequisite of the pharmaceutical, biomedical or medical device industry. The Quality Management Sys…
 
James Clear is the author of the New York Times bestseller Atomic Habits. His extensive research into human behavior has helped him identify key components of habit formation and develop the “Four Laws of Behavioral Change.” In this episode, James provides insights into how both good and bad habits are formed, including the influence of genetics, e…
 
In this episode, Paul discusses the Ninth Circuit's decision to vacate EPA's CAFO permit for Idaho. Materials discussed in this episode: Goeringer, Paul. Idaho CAFO Permit Sent Back to EPA for Lack of Monitoring (Sept. 28, 2021). If you have questions for Paul contact him at lgoering@umd.edu, tweet him @aglawPaul, follow him on Instagram, or 301-40…
 
What can a medical assistant do – and not do? Medical assistants have a narrow list of tasks they can perform for patients or for a doctor in a doctor's office. It's often difficult to know what's allowed, because there are not strong laws or regulations in place regarding medical assistants. Since no one really “regulates” them, and they are frigh…
 
This week, Stacey is joined by Amanda Coogan to discuss the opportunities and challenges of implementing automated clinical trial management solutions using RBM. Given our current environment, it is no surprise that pharma and device companies are doing everything possible to boost efficiencies. Increasing drug development and production in safe an…
 
David Nutt is a psychiatrist and a neuroscientist at Downing College, Cambridge. His research focuses on illicit drugs—their harm, classification, and potential for therapeutic use in psychiatry. In this episode, David discusses his framework for assessing the potential harm caused by common recreational drugs and explains how they are regulated, w…
 
Outpatient CDI expert Colleen Deighan will return to the next edition of Talk Ten Tuesdays to continue her popular series on a subject that continues to generate listener interest and questions. Deighan will also conduct a listener’s survey during the weekly Internet radio broadcast. When healthcare organizations are considering, planning, or begin…
 
This week, Stacey is joined by Bryan Prince to talk about the implementation of the 2019 final version of USP 800, and how it is not currently being enforced by most states but quite a few pharmacies around the country are either in the planning and budgeting phase or have already moved forward with construction and being compliant with USP 800 sta…
 
Robert (Bob) Gatenby is a radiologist who specializes in exploring theoretical and experimental models of evolutionary dynamics in cancer and cancer drug resistance. He has developed an adaptive therapy approach for treating cancer which has shown promise in improving survival times with less cumulative drug use. In this episode, Bob explains what …
 
In this episode, Paul discusses the Ninth Circuit's decision upholding the Montana beef checkoff program. Materials discussed in this episode: Goeringer, Paul. Ninth Circuit Rules in Favor of Beef Checkoff Program (Aug. 17, 2021). R-CALF v. Vilsack, No. 20-35453, 2021 WL 3161201 (9th Cir. 2021). If you have questions for Paul contact him at lgoerin…
 
We’re taking AIM at reducing maternal morbidity and mortality during an exclusive four-part series on ICD10monitor and Talk Ten Tuesdays. The series will be led by senior healthcare consultant Kristi Pollard, Director of Coding Quality and Education for the Haugen Consulting Group. During her series, Kristi will discuss how coded data is being used…
 
This week, Stacey is joined by Nuala Calnan and Valerie Mulholland for an Ask Me Anything session on Quality Risk Management. Valerie answers questions about ICH Q9, ISO Divergence, ICH Q12, Analytical Lifecycle Management, Quality Management Maturity, and much more. Welcome to Risk Revolution, a monthly series of the Voices in Validation podcast, …
 
In this “Ask Me Anything” (AMA) episode, Peter and Bob discuss all things related to testosterone: what happens when testosterone levels are low, and the potential benefits and risks of testosterone replacement therapy (TRT). They explain the physiology of testosterone, how it works, and how its level changes over the course of a person's life. The…
 
Outpatient CDI programs can have real impact with risk adjustment and Hierarchical Condition Categories (HCCs). An important component of the HCC risk adjustment model is accurate and appropriate HCC capture, representing a patient’s disease burden year over year. HCCs reflect hierarchies within related disease categories. A patient can have multip…
 
This week, Stacey and industry expert, Chris Wubbolt, count down the top five data integrity issues when complying with GMP guidance. Data Integrity is a critical element to GMP compliance, and all life science manufacturers need to develop and maintain processes for managing their data, reducing the risk to the integrity of that data, and stored p…
 
Jeremy Loenneke has a Ph.D. in exercise physiology, a Master’s in nutrition and exercise, and is currently the director of the Kevser Ermin Applied Physiology Laboratory at the University of Mississippi, where he focuses his research on skeletal muscle adaptations to exercise in combination with blood flow restriction (BFR). In this episode, Jeremy…
 
In this episode, Paul discusses a decision out of Texas involving a nuisance suit with two poultry farms and neighboring landowners. Materials discussed in this episode: Goeringer, Paul. State Court Decision Highlights When Right-to-Farm Laws Might Not Apply (Sept. 15, 2021). Huynh v. Blanchard, No. 12-20-00198-CV, 2021 WL 3265549 (Tex. Ct. App. Ju…
 
The COVID-19 pandemic rages on, exposing huge gaps in America’s vulnerable healthcare system, posing life-or-death questions that tear at our collective subconsciousness. There’s also the constant drumbeat of headline news: vaccination mandates versus personal freedom, for example. Are two shots sufficient, or are three better? Should young childre…
 
This week, Stacey welcomes back Siegfried Schmitt to the show. Stacey and Siegfried discuss the complexities in supply chain management, the expectations for a GDP audit, and deficiencies in distribution processes. Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry. Just like in other a…
 
Lance Armstrong is a legendary figure in professional cycling having won seven consecutive Tour de France titles but also a controversial figure facing scrutiny for the use of performance enhancing drugs. In this episode, Lance takes us through his meteoric rise to one of the most famous athletes in the world and his equally accelerated fall from g…
 
This week, Stacey is joined by Ken Shitamoto to explore critical thinking in the systems validation department and share concepts and case history. Most industry folks have heard about CSA and understand the basics behind the shift in priorities. What’s better left to understand is the if’s and how’s around adoption and implementation within our ow…
 
Physician engagement, query productivity, and revenue integrity are some but not all of the activities that encompass today’s outpatient clinical documentation integrity (OP CDI) arena, which continues to gain traction among America’s hospitals and health systems. During an exclusive broadcast report, CDI expert Colleen Deighan will unveil a Talk T…
 
Steve Rosenberg is the Chief of Surgery at the National Cancer Institute, a position he has held continuously for the past 47 years. Steve is a pioneer in the field of immunotherapies for cancer and a recipient of nearly every major award in science. In this episode, Steve discusses his inspiration for devoting his career to cancer research and des…
 
In this episode, Paul is joined by Jackie Schweichler, Staff Attorney at the Center for Agricultural and Shale Law at Penn State University, to discuss her role managing Pennsylvania's Agricultural Mediation Program. Materials discussed: Maryland Agricultural Conflict Resolution Service Pennsylvania Agricultural Mediation Program Penn State Center …
 
The National Institutes of Health (NIH) is awarding $470 million to New York University to perform a national study on “tens of thousands of people, to research the long-term effects of COVID-19.” One such individual who might be included in the study will be the special guest during the next live edition of Talk-Ten-Tuesdays: Deborah Grider, longt…
 
This week, Stacey is joined by Renee Phillips to discuss the pros and cons of transitioning to a continuous manufacturing system. Batch production is time-consuming yet remains a popular and time-tested method used in the pharma industry today - but some industry leaders, along with the FDA, have taken steps toward or are now contemplating a shift …
 
In this “Ask Me Anything” (AMA) episode, Peter and Bob discuss the longevity benefits from greater cardiorespiratory fitness (CRF) and greater muscle mass and strength. Conversely, they dive deep into the literature showing a rapid increase in morbidity and mortality risk as fitness levels decline with age. They also try to tease out the relative c…
 
The COVID-19 pandemic continues to rage throughout the U.S., fueled by the Delta variant that is driving a new surge of infections of the deadly coronavirus – all this amid growing antagonism about mask mandates and vaccine hesitancy. The U.S. death toll now stands at more than 650,000, with projections indicating more than 750,000 deaths being lik…
 
This week, Stacey and Nuala invite a regular IVT contributor and industry disruptor Karen Ginsbury to innovate and revolutionize the future of quality management within the pharmaceutical and biopharmaceutical, and med device sectors. Karen will share her views on ICH Q10 and what must happen next. Resources from this episode: One Voice of Quality …
 
Matt Kaeberlein is globally recognized for his research on the biology of aging and is a previous guest on The Drive. In this episode, Matt defines aging, the relationship between aging, chronic inflammation, and the immune system, and talks extensively about the most exciting molecules for extending lifespan. He discusses the current state of the …
 
In this episode, Stacey is joined by David Nettleton to discuss some of the key topics from the recent CSV Virtual Week panel "CSA Revolution." The session "CSA Revolution" was intended to provide a better understanding of the intent and scope of the FDA’s Computer Software Assurance guidance while highlighting CSA’s relationship to other existing …
 
Lawrence Wright is the author of The Looming Tower: Al-Qaeda and the Road to 9/11 which won the 2007 Pulitzer Prize for general nonfiction and was named one of Time's top 100 books of all time. In this episode, released just before the 20th anniversary of the September 11th attacks, Lawrence and Peter discuss the book and the lasting impact of that…
 
In this episode, Paul is joined by Brook Duer, Staff Attorney at the Center for Agricultural and Shale Law at Penn State University, to discuss his work on legal issues landowners should consider when leasing farmland for solar development. Materials discussed: Penn State Center for Agricultural and Shale Law. Penn State Solar Law Videos (2021) If …
 
Questions and concerns about the recent and significant updates to Patient Safety Indicators (PSI) by the Agency for Healthcare Research and Quality (AHRQ) has prompted the return of Dr. James Kennedy, a subject matter expert on PSIs, to the next live edition of Talk Ten Tuesdays. The live broadcast will also feature these other segments: Coding Re…
 
In this episode, we will hear an exclusive panel discussion CSV Virtual Event "CSA Revolution." This discussion will provide a better understanding of the intent and scope of the FDA’s Computer Software Assurance guidance while highlighting CSA’s relationship to other existing regulations. Key concepts of CSA include the push for critical thinking …
 
The Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators (PSIs) – which factor greatly into provider success with the Medicare Inpatient Quality Reporting, Leapfrog, and Maryland quality initiatives – were recently significantly updated for the 2021 fiscal year (FY). During the next live edition of Talk Ten Tuesdays, you’ll l…
 
In this “Ask Me Anything” (AMA) episode, Peter and Bob answer numerous follow-up questions to recently discussed deep-dive topics such as the use of continuous glucose monitors and getting the most from zone 2 exercise. They also discuss the incredible feats of cyclists in the Tour de France through the lens of the amazing performance physiology re…
 
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