Regulations Rx Thu, 05 Mar 2026 02:45:15 -0500 https://www.sdbio.org/podcasts en-us © 2026 Regulations Rx no ab136201-8f56-53ee-ae95-e3052b2f294b Aaron & Leslie episodic false Ever wonder why Americans pay the most for healthcare globally, yet don't get the health outcomes they deserve?  Aaron Harmon searches for answers, unearthing the hidden stories behind the regulations shaping healthcare in America. If you want to explore these questions and learn about the stories behind healthcare regulations in America, tune in to RegulationsRx.


]]> Buzzsprout (https://www.buzzsprout.com) Quality Assurance, QA, SDBio, Biotech, Medical Devices Aaron & Leslie https://storage.buzzsprout.com/o628nm7n4y6w17u1krgw8a6gwbdb?.jpg Regulations Rx https://www.sdbio.org/podcasts Our Little Bill: The Nuances of Bills Becoming Laws with Worth Hester Our Little Bill: The Nuances of Bills Becoming Laws with Worth Hester We all know the song "I'm Just a Bill," but there are many nuances and political maneuvers in the process of bills being created and making their ways to become law. To help me learn more, Worth Hester joined me.

Worth joined the faculty of the Government Affairs Institute at Georgetown University in 1988 as a Presidential Management Fellow and became an Assistant Director in 1999. During seven years of government service, he served as an Employee Development Specialist, Program Analyst, and Legislative Analyst for a Member of Congress. Worth also spent two years as Senior Staff with the Center for Public Policy Education at the Brookings Institution.

He is incredibly knowledgeable about the processes in congress making this a fun podcast to make.

To learn more about the work of the Government Affairs Institute, check out their website: https://gai.georgetown.edu/
 

]]> We all know the song "I'm Just a Bill," but there are many nuances and political maneuvers in the process of bills being created and making their ways to become law. To help me learn more, Worth Hester joined me.

Worth joined the faculty of the Government Affairs Institute at Georgetown University in 1988 as a Presidential Management Fellow and became an Assistant Director in 1999. During seven years of government service, he served as an Employee Development Specialist, Program Analyst, and Legislative Analyst for a Member of Congress. Worth also spent two years as Senior Staff with the Center for Public Policy Education at the Brookings Institution.

He is incredibly knowledgeable about the processes in congress making this a fun podcast to make.

To learn more about the work of the Government Affairs Institute, check out their website: https://gai.georgetown.edu/
 

]]> Aaron with Worth Hester Buzzsprout-18270170 Mon, 12 Jan 2026 05:00:00 -0600 2967 Congress, Laws, Bills, Government Process, Regulatory Science 4 4 full false Abraham Lincoln's Impact on Healthcare Abraham Lincoln's Impact on Healthcare In the early 1860's the US was torn apart by war and opposing ideas. In the midst of the conflict, President Lincoln created the USDA, one of the first healthcare laws, and laid the foundations for what would now be known as the FDA. 

To help me dive into President Lincoln's impact and explore the history of his presidency, I'm joined by Erin Carlson Mast, President and CEO of the Lincoln Presidential Foundation.

The Lincoln Presidential Foundation, formerly known as the Abraham Lincoln Presidential Library Foundation, is a 501c3 nonprofit with over two decades of experience leading and supporting efforts to share the story of Abraham Lincoln’s life, legacy, and leadership with the world. Learn more about the Lincoln Presidential Foundation here: https://www.lincolnpresidential.org/

]]> In the early 1860's the US was torn apart by war and opposing ideas. In the midst of the conflict, President Lincoln created the USDA, one of the first healthcare laws, and laid the foundations for what would now be known as the FDA. 

To help me dive into President Lincoln's impact and explore the history of his presidency, I'm joined by Erin Carlson Mast, President and CEO of the Lincoln Presidential Foundation.

The Lincoln Presidential Foundation, formerly known as the Abraham Lincoln Presidential Library Foundation, is a 501c3 nonprofit with over two decades of experience leading and supporting efforts to share the story of Abraham Lincoln’s life, legacy, and leadership with the world. Learn more about the Lincoln Presidential Foundation here: https://www.lincolnpresidential.org/

]]> Aaron & Erin Mast Buzzsprout-18270180 Mon, 15 Dec 2025 06:00:00 -0600 2110 FDA, Abraham Lincoln, Charles Wetherill, False Claims Act, Regulations, Civil War 4 3 full false Externalities: Janet Parker and Rural Healthcare Regulations Externalities: Janet Parker and Rural Healthcare Regulations How does something intended for good, cause harm? That's the topic explored in this episode. The concept is Externalities, which is a cost or a benefit that affects a third party who is not directly involved in an economic activity or transaction. These impacts can be either negative or positive.

This mundane-sounding concept can play out in big impacts. We explore how research meant to end a killer virus, resulted in an unlikely final victim, Janet Parker. This story is explored with our guest Dr. Mark Pallen, a retired professor from the Quadram Institute and author of the book: The Last Days of Smallpox. 

We are also joined by Dr. Tom Dean, who served as a family physician, and Medicare Payment Advisory Commission member for Congress. He shares about externalities during his tenure on MedPAC. 

To read Dr. Pallen's book and learn the whole story, find it here: Amazon 

Read more from Dr. Tom Dean through his writings in South Dakota Searchlight here: SD Searchlight

]]> How does something intended for good, cause harm? That's the topic explored in this episode. The concept is Externalities, which is a cost or a benefit that affects a third party who is not directly involved in an economic activity or transaction. These impacts can be either negative or positive.

This mundane-sounding concept can play out in big impacts. We explore how research meant to end a killer virus, resulted in an unlikely final victim, Janet Parker. This story is explored with our guest Dr. Mark Pallen, a retired professor from the Quadram Institute and author of the book: The Last Days of Smallpox. 

We are also joined by Dr. Tom Dean, who served as a family physician, and Medicare Payment Advisory Commission member for Congress. He shares about externalities during his tenure on MedPAC. 

To read Dr. Pallen's book and learn the whole story, find it here: Amazon 

Read more from Dr. Tom Dean through his writings in South Dakota Searchlight here: SD Searchlight

]]> Aaron Buzzsprout-18115560 Wed, 05 Nov 2025 06:00:00 -0600 2022 4 2 full false The Biological Hijacking by Opioids The Biological Hijacking by Opioids On our first episode of this season, Tracey shares the story of her son Mac who lost his life to the opioids. Despite years of creating laws and regulations, we haven't been able to stop the destruction. Biology is partly to blame. I’m joined by Lee Baugh, Associate Professor at the University of South Dakota and neuroscientist and researcher Jamie Bushman (also from the University of South Dakota) to explore the biology of addiction and how opioids hijack our biology and better understand why we still fail to control these drugs.

]]> On our first episode of this season, Tracey shares the story of her son Mac who lost his life to the opioids. Despite years of creating laws and regulations, we haven't been able to stop the destruction. Biology is partly to blame. I’m joined by Lee Baugh, Associate Professor at the University of South Dakota and neuroscientist and researcher Jamie Bushman (also from the University of South Dakota) to explore the biology of addiction and how opioids hijack our biology and better understand why we still fail to control these drugs.

]]> Aaron Buzzsprout-18007175 Tue, 14 Oct 2025 06:00:00 -0500 2208 Opioids, Oxycontin, Fentanyl, Regulations, Healthcare. 4 1 full false Transition from Inside Out Quality to Regulations Rx. Transition from Inside Out Quality to Regulations Rx. Our name has changed and new episodes are coming! I'm excited to bring you a new season, starting soon!

]]> Our name has changed and new episodes are coming! I'm excited to bring you a new season, starting soon!

]]> Aaron Buzzsprout-17800926 Sat, 06 Sep 2025 21:00:00 -0500 46 4 trailer false The Therapeutic Power of Stories. The Therapeutic Power of Stories. “I will tell you something about stories. They aren't just entertainment. They are all we have to fight off illness and death. You don't have anything if you don't have stories.” ― Leslie Marmon Silko

The story of Scott Jerome Parks captivated me and the filled headlines in 2010. His story led me to connect with people around the US and world and, ultimately, to Dr. Joel Carter, a palliative care physician. While treating patients, Joel discovered that stories alone provided relief from pain and improved the well being of patients suffering in the end stages of cancer.

In this episode, Joel tells us the story which led him to this discovery. Deb Murphy and Pam McKenney also share their stories on overcoming cancer and how radiation treatment was a component in that fight. This podcast is all about sharing stories to encourage and educate those working to improve lives --let's continue our work of helping others make many more stories. 

To learn more about Dr. Joel Carter, visit his website here: https://joelcartermd.com/

]]> “I will tell you something about stories. They aren't just entertainment. They are all we have to fight off illness and death. You don't have anything if you don't have stories.” ― Leslie Marmon Silko

The story of Scott Jerome Parks captivated me and the filled headlines in 2010. His story led me to connect with people around the US and world and, ultimately, to Dr. Joel Carter, a palliative care physician. While treating patients, Joel discovered that stories alone provided relief from pain and improved the well being of patients suffering in the end stages of cancer.

In this episode, Joel tells us the story which led him to this discovery. Deb Murphy and Pam McKenney also share their stories on overcoming cancer and how radiation treatment was a component in that fight. This podcast is all about sharing stories to encourage and educate those working to improve lives --let's continue our work of helping others make many more stories. 

To learn more about Dr. Joel Carter, visit his website here: https://joelcartermd.com/

]]> Aaron & Leslie Buzzsprout-12938790 Tue, 06 Jun 2023 05:00:00 -0500 2129 Scott Jerome Parks, Radiation Safety, Quality Assurance, Stories, Joel Carter, Therac 25, FDA, Healthcare, Podcast 3 11 full false Keeping Radiation Safe: Todd Pawlicki and LINACs Keeping Radiation Safe: Todd Pawlicki and LINACs Gordon Isaacs sat on a table at Stanford Medical School in 1955. A large linear accelerator shadowed behind him while he waited for treatment of the tumor growing in his retina. He made history as the first patient treated in the US with this radiation therapy approach. Linear Accelerators (LINACs) have come a long way since that time and have treated millions. How has there been so much success? The answer is a harmonization between quality and engineering.

Dr. Todd Pawlicki, Professor and Vice Chair of the Department of Radiation Medicine and Applied Sciences at UC San Diego's School of Medicine joins Leslie and I to talk LINACs, Quality, and the role of Physicists in healthcare.  Dr. Pawlicki is an expert and leader in the field of radiation oncology (and quality nerd!). Click here to learn more about Dr. Pawlicki's work.

ASTRO is the group of professionals working to continue improving radiation therapy. They helped connect me to Dr. Pawlicki and are a great resource for professionals and patients!
 
Information for patients can be found here 
 

]]> Gordon Isaacs sat on a table at Stanford Medical School in 1955. A large linear accelerator shadowed behind him while he waited for treatment of the tumor growing in his retina. He made history as the first patient treated in the US with this radiation therapy approach. Linear Accelerators (LINACs) have come a long way since that time and have treated millions. How has there been so much success? The answer is a harmonization between quality and engineering.

Dr. Todd Pawlicki, Professor and Vice Chair of the Department of Radiation Medicine and Applied Sciences at UC San Diego's School of Medicine joins Leslie and I to talk LINACs, Quality, and the role of Physicists in healthcare.  Dr. Pawlicki is an expert and leader in the field of radiation oncology (and quality nerd!). Click here to learn more about Dr. Pawlicki's work.

ASTRO is the group of professionals working to continue improving radiation therapy. They helped connect me to Dr. Pawlicki and are a great resource for professionals and patients!
 
Information for patients can be found here 
 

]]> Aaron & Leslie Buzzsprout-12635712 Tue, 16 May 2023 05:00:00 -0500 2587 3 10 full false Therac 25 in the Classroom with Natalia Silvis-Cividjian Therac 25 in the Classroom with Natalia Silvis-Cividjian Scott Jerome Parks died in 2007 from a radiation overdose. His slow, agonizing death captured headlines. Headlines were followed by a congressional hearing, where his dad shared of Scott's suffering and the need for reform in medical device and radiation safety.  As I learned of his story, it brought me to many more stories. The first being the Therac 25.

Natalia Silvis-Cividjian also found the story of the Therac 25. She too became captured and harnessed its lessons to teach students the importance of effective software testing. Natalia is a lecturer at the Vrije University in Amsterdam and joins me to talk about software, radiation, and the tragedy of the Therac 25.

To learn about Natalia's project to teach and preserve software bugs for teaching click here.    

]]> Scott Jerome Parks died in 2007 from a radiation overdose. His slow, agonizing death captured headlines. Headlines were followed by a congressional hearing, where his dad shared of Scott's suffering and the need for reform in medical device and radiation safety.  As I learned of his story, it brought me to many more stories. The first being the Therac 25.

Natalia Silvis-Cividjian also found the story of the Therac 25. She too became captured and harnessed its lessons to teach students the importance of effective software testing. Natalia is a lecturer at the Vrije University in Amsterdam and joins me to talk about software, radiation, and the tragedy of the Therac 25.

To learn about Natalia's project to teach and preserve software bugs for teaching click here.    

]]> Aaron & Leslie Buzzsprout-12484072 Tue, 02 May 2023 05:00:00 -0500 2984 3 9 full false Science and (Quality) is About Questions Science and (Quality) is About Questions In this episode, Dr. David Evans, Virologist at the University of Alberta joins Leslie and I, where we explore a question he once asked. Could he and his team synthetically recreate horsepox virus? 

Science is all about asking questions and creating experiments to answer them. These questions can make us uncomfortable. Quality Assurance also thrives on questions. Listen in while we discuss his experiment and ask him questions.

Link to Dr. Evans' publication on horsepox virus:
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0188453 

]]> In this episode, Dr. David Evans, Virologist at the University of Alberta joins Leslie and I, where we explore a question he once asked. Could he and his team synthetically recreate horsepox virus? 

Science is all about asking questions and creating experiments to answer them. These questions can make us uncomfortable. Quality Assurance also thrives on questions. Listen in while we discuss his experiment and ask him questions.

Link to Dr. Evans' publication on horsepox virus:
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0188453 

]]> Aaron & Leslie Buzzsprout-12258248 Wed, 08 Mar 2023 05:00:00 -0600 1881 3 8 full false The Opioid Crisis: The role of sales with Alec Burlakoff The Opioid Crisis: The role of sales with Alec Burlakoff In 1920, the US began recording deaths from Opioids; between 1920 and 1921, 105 people died from accidental overdose.

In 2021, 80,816 people died from overdose on opioids (CDC). We are losing a battle. The opioid crisis is a healthcare system problem; one component of this system is the sales rep. In this episode, we interview Alec Burlakoff. Alec was the VP for sales at Insys and a master of sales and building teams. His skills, contributed to explosive sales of Fentanyl and current crisis. 

Alec joins Leslie and I, so we begin to understand how we each parts of healthcare contributed to the crisis. We discuss sales and Alec shares about his life and work. 

To learn more about Alec's current work, see his sites:

Limitless! Sales Coaching  https://course.aburlakoff.com/home
SCHEDULE FREE 20 minute Consult https://bit.ly/3WEunxw

]]> In 1920, the US began recording deaths from Opioids; between 1920 and 1921, 105 people died from accidental overdose.

In 2021, 80,816 people died from overdose on opioids (CDC). We are losing a battle. The opioid crisis is a healthcare system problem; one component of this system is the sales rep. In this episode, we interview Alec Burlakoff. Alec was the VP for sales at Insys and a master of sales and building teams. His skills, contributed to explosive sales of Fentanyl and current crisis. 

Alec joins Leslie and I, so we begin to understand how we each parts of healthcare contributed to the crisis. We discuss sales and Alec shares about his life and work. 

To learn more about Alec's current work, see his sites:

Limitless! Sales Coaching  https://course.aburlakoff.com/home
SCHEDULE FREE 20 minute Consult https://bit.ly/3WEunxw

]]> Aaron & Leslie Buzzsprout-11916966 Tue, 03 Jan 2023 05:00:00 -0600 2575 Opioid, Fentanyl, Morphine, Incentives, Healthcare 3 7 full false Speaking of Quality... Actress Michelle Hutchison Speaking of Quality... Actress Michelle Hutchison Michelle Hutchison is an actress, voiceover coach, writer, and producer. She also teaches professionals in the medical product industries on how to present more effectively-- we knew we couldn't talk about motivational speaking with talking about the speaking part!

In this episode, Michelle talks about performance in presentations with Leslie and I to discuss getting past slide decks and communicating with skilled expression and your emotional palette. 

To learn more about Michelle's classes visit: https://www.skilledexpressions.com/

]]> Michelle Hutchison is an actress, voiceover coach, writer, and producer. She also teaches professionals in the medical product industries on how to present more effectively-- we knew we couldn't talk about motivational speaking with talking about the speaking part!

In this episode, Michelle talks about performance in presentations with Leslie and I to discuss getting past slide decks and communicating with skilled expression and your emotional palette. 

To learn more about Michelle's classes visit: https://www.skilledexpressions.com/

]]> Aaron & Leslie Buzzsprout-11827617 Tue, 20 Dec 2022 05:00:00 -0600 2640 Acting, Presentation, Quality Assurance, Emotions, Expressions 3 6 full false Speaking of Quality...Quality Assurance Contributing to the Bottom Line with Bart Bosch Speaking of Quality...Quality Assurance Contributing to the Bottom Line with Bart Bosch Earlier this year, I began searching for a Quality Assurance motivational speaker. This search introduced me to many amazing people; Bart Bosch is one of them.  Bart is the founder of Vlitix and specializes in utilizing quality systems as a value driver for organizations. 

If you want to turn Quality Assurance into a value driver for your company, this is your episode! Listen in as Bart and I discuss how quality can make your company more valuable and contribute to the bottom line. 

To reach out to Bart, his email is bart@vlitix.com

https://www.vlitix.com/

]]> Earlier this year, I began searching for a Quality Assurance motivational speaker. This search introduced me to many amazing people; Bart Bosch is one of them.  Bart is the founder of Vlitix and specializes in utilizing quality systems as a value driver for organizations. 

If you want to turn Quality Assurance into a value driver for your company, this is your episode! Listen in as Bart and I discuss how quality can make your company more valuable and contribute to the bottom line. 

To reach out to Bart, his email is bart@vlitix.com

https://www.vlitix.com/

]]> Aaron & Leslie Buzzsprout-11731237 Tue, 06 Dec 2022 05:00:00 -0600 1853 Vlitix, Quality Assurance, complaints, Quality, Sustainable business, South Dakota Biotech 3 5 full false Orkin Helps Us Think Like a Cockroach Orkin Helps Us Think Like a Cockroach In the world of GMPs and quality, it's easy to overlook the importance of pest management until its too late. In this episode,  Frank Meek, Manager of Technical Services at Rollins/Orkin joins us to tell us how Orkin approaches all things pest control, from prevention, investigations, and control of pest along with other services they provide the industry. 

Frank Meek is a Technical Services Manager for Rollins. As a board-certified entomologist and 30-year industry veteran, he is an acknowledged leader in the field of pest management.  He loves insects, spiders, and crawl spaces. Listen in as Frank shares his passion for pest control and teaches Leslie and I how to be better insect detectives.

To reach out to Orkin's industry team, visit here: https://www.orkincommercial.com/ 

You can also visit: https://www.orkin.com

]]> In the world of GMPs and quality, it's easy to overlook the importance of pest management until its too late. In this episode,  Frank Meek, Manager of Technical Services at Rollins/Orkin joins us to tell us how Orkin approaches all things pest control, from prevention, investigations, and control of pest along with other services they provide the industry. 

Frank Meek is a Technical Services Manager for Rollins. As a board-certified entomologist and 30-year industry veteran, he is an acknowledged leader in the field of pest management.  He loves insects, spiders, and crawl spaces. Listen in as Frank shares his passion for pest control and teaches Leslie and I how to be better insect detectives.

To reach out to Orkin's industry team, visit here: https://www.orkincommercial.com/ 

You can also visit: https://www.orkin.com

]]> Aaron & Leslie Buzzsprout-11593943 Tue, 22 Nov 2022 05:00:00 -0600 2396 Orkin, Quality, Pest Control, Insects, Rodents 3 4 full false Gabriel Licina: From Biohacker to Independent Researcher Gabriel Licina: From Biohacker to Independent Researcher Gabriel Licina is a leader in the world of independent science and was at the forefront of the biohacking culture. His work showed that exciting technology can be created from the home using networking, education, and freedom. 

I expected someone known as a Biohacker to be resistant to regulations and quality concepts, but I quickly learned the opposite. On this episode, Gabriel joins Leslie and I to talk about Biohacking, how he became an Independent Researcher, his research, and how the regulations are still important in this space for safety and progress.

You can learn more about Gabriel here: https://www.scihouse.space/

]]> Gabriel Licina is a leader in the world of independent science and was at the forefront of the biohacking culture. His work showed that exciting technology can be created from the home using networking, education, and freedom. 

I expected someone known as a Biohacker to be resistant to regulations and quality concepts, but I quickly learned the opposite. On this episode, Gabriel joins Leslie and I to talk about Biohacking, how he became an Independent Researcher, his research, and how the regulations are still important in this space for safety and progress.

You can learn more about Gabriel here: https://www.scihouse.space/

]]> Aaron & Leslie Buzzsprout-11462981 Tue, 08 Nov 2022 05:00:00 -0600 2752 3 3 full false Mrs. Winslow's Soothing Syrup Mrs. Winslow's Soothing Syrup “Are you disturbed at night and broken of your rest by a sick child suffering…. It will relieve the poor sufferer…and is the prescription of one of the oldest and best female physicians and nurses in the United States.” --This is not an ad about our podcast :) This is an add from 1905 for Mrs. Winslow's Soothing Syrup (a morphine based product advertised to help sooth children)

FDA Historian Vanessa Burrows joins Leslie and I, as we dive into a notorious opioid product sold from the 1830's-1930's resulting in countless deaths and misled consumers. This episode underscores the importance of product labeling, advertising, and muckrakers in the history of drug development and regulations.

To learn more about the work of the FDA's History Office, check out their site:
www.fda.gov/history 


]]> “Are you disturbed at night and broken of your rest by a sick child suffering…. It will relieve the poor sufferer…and is the prescription of one of the oldest and best female physicians and nurses in the United States.” --This is not an ad about our podcast :) This is an add from 1905 for Mrs. Winslow's Soothing Syrup (a morphine based product advertised to help sooth children)

FDA Historian Vanessa Burrows joins Leslie and I, as we dive into a notorious opioid product sold from the 1830's-1930's resulting in countless deaths and misled consumers. This episode underscores the importance of product labeling, advertising, and muckrakers in the history of drug development and regulations.

To learn more about the work of the FDA's History Office, check out their site:
www.fda.gov/history 


]]> Aaron & Leslie Buzzsprout-11411505 Mon, 24 Oct 2022 05:00:00 -0500 2156 Mrs. Winslow's Soothing Syrup, morphine, medicine, marketed, patent medicines, drugs, children, women, law, state, quality, manufacturer 3 2 full false Yugo: Power in a Reputation, Not the Car. Yugo: Power in a Reputation, Not the Car. Jason Vuic, author and historian, joins Leslie and I to discuss one of the best examples of quality reputation and public perception: the Yugo.

Zastava manufactured the low cost car in the 1980's, but low cost could not overcome the quality issues that turned the name Yugo, into a punchline for jokes. Car and Driver named it "Worst Car in History."

Jason wrote the book: The Yugo -The Rise and Fall of the Worst Car in History and joins us to discuss the impact of quality on reputation and how the Yugo fits into history.

To learn more about Jason Vuic and his work, see his website:  https://www.jasonvuic.com/home

]]> Jason Vuic, author and historian, joins Leslie and I to discuss one of the best examples of quality reputation and public perception: the Yugo.

Zastava manufactured the low cost car in the 1980's, but low cost could not overcome the quality issues that turned the name Yugo, into a punchline for jokes. Car and Driver named it "Worst Car in History."

Jason wrote the book: The Yugo -The Rise and Fall of the Worst Car in History and joins us to discuss the impact of quality on reputation and how the Yugo fits into history.

To learn more about Jason Vuic and his work, see his website:  https://www.jasonvuic.com/home

]]> Aaron & Leslie Buzzsprout-11282667 Tue, 11 Oct 2022 05:00:00 -0500 3238 Car, Yugo, Quality, Jason Vuic, Reputation, Regulatory 3 1 full false Emotions in Quality: De-escalation and a Tribute Emotions in Quality: De-escalation and a Tribute Quality Assurance professionals are tasked with bringing continuous improvement to organizations. This means change. Change can evoke emotions.  Do we prepare our quality professionals to navigate emotional conflict?   

This episode discusses tactics to minimize and de-escalate conflict in the workplace with help from Joel Reinesch, Assistant Professor of Criminal Justice at Dakota Wesleyan University, former Police Officer, and Marine. 

Special Agent Wade Krieger inspired the idea for this podcast and had planned to record this with me. He passed away in 2021. The episode is a tribute to him.

]]> Quality Assurance professionals are tasked with bringing continuous improvement to organizations. This means change. Change can evoke emotions.  Do we prepare our quality professionals to navigate emotional conflict?   

This episode discusses tactics to minimize and de-escalate conflict in the workplace with help from Joel Reinesch, Assistant Professor of Criminal Justice at Dakota Wesleyan University, former Police Officer, and Marine. 

Special Agent Wade Krieger inspired the idea for this podcast and had planned to record this with me. He passed away in 2021. The episode is a tribute to him.

]]> Aaron & Diane Buzzsprout-9878797 Wed, 12 Jan 2022 22:00:00 -0600 2583 Quality Assurance, Emotions, De-Escalation, Law Enforcement, Leadership, OIG, Conflict Management 2 10 full false After The Warning Letter with FDA Attorney Amanda Johnston. After The Warning Letter with FDA Attorney Amanda Johnston. Warning Letters are more than a slap on the wrist.  They are the first step in what can be a costly remediation and legal battle.  

How do we prevent them? What is within the power of the FDA and government when they spot quality issues? To help us with these questions and more, we are joined by Amanda Johnston of Gardner Law. Amanda has over a decade of experience in FDA Regulatory Law and experience with all sizes of companies.


To learn more about Gardener Law, check out their website: https://gardner.law/ 

]]> Warning Letters are more than a slap on the wrist.  They are the first step in what can be a costly remediation and legal battle.  

How do we prevent them? What is within the power of the FDA and government when they spot quality issues? To help us with these questions and more, we are joined by Amanda Johnston of Gardner Law. Amanda has over a decade of experience in FDA Regulatory Law and experience with all sizes of companies.


To learn more about Gardener Law, check out their website: https://gardner.law/ 

]]> Aaron & Diane Buzzsprout-9791275 Tue, 28 Dec 2021 08:00:00 -0600 1424 FDA, Warning, Letter, Quality Assurance, Remediation, Medical Devices, Regulatory Affairs, False Claims Act 2 9 full false Intermission: Shannon Van Buskirk --SD Bio Member Relations Specialist Intermission: Shannon Van Buskirk --SD Bio Member Relations Specialist On this intermission, we meet Shannon Van Buskirk. She recently joined SD Bio to provide  extra support for members and is jumping into our community. She brings a background in pharmaceutical sales, talent on the piano, and a passion for meeting new people. If you haven't met her yet, you definitely should!

p.s. we recorded this the week before Thanksgiving, and I showed up wearing a turkey hat for the interview.

]]> On this intermission, we meet Shannon Van Buskirk. She recently joined SD Bio to provide  extra support for members and is jumping into our community. She brings a background in pharmaceutical sales, talent on the piano, and a passion for meeting new people. If you haven't met her yet, you definitely should!

p.s. we recorded this the week before Thanksgiving, and I showed up wearing a turkey hat for the interview.

]]> Aaron & Diane Buzzsprout-9634571 Tue, 30 Nov 2021 05:00:00 -0600 922 full false Intermission: Aaron Harmon --Reversing Roles with Joni Intermission: Aaron Harmon --Reversing Roles with Joni In this intermission Aaron Harmon, podcaster and General Manager for Inanovate Inc.  joins us, as Joni Ekstrum interviews Aaron and takes her turn at hosting an episode.   

Aaron started this podcast with the hopes of sharing stories and exploring the world of quality assurance through interviews with amazing people. On this episode you'll get to know him more as he sits on the other side of the questions. 

]]> In this intermission Aaron Harmon, podcaster and General Manager for Inanovate Inc.  joins us, as Joni Ekstrum interviews Aaron and takes her turn at hosting an episode.   

Aaron started this podcast with the hopes of sharing stories and exploring the world of quality assurance through interviews with amazing people. On this episode you'll get to know him more as he sits on the other side of the questions. 

]]> Aaron & Diane Buzzsprout-9583250 Tue, 23 Nov 2021 05:00:00 -0600 324 full false The Beauty of Regulations The Beauty of Regulations The FDA stands for The Food and Drug Administration, but they are also key in regulating the cosmetic industry.  In 1938, The Federal Food, Drug, and Cosmetic Act gave the FDA the responsibility for regulating cosmetics and protecting customers. 

To explore how cosmetics are regulated, Charmain Rodriques, Regulatory Affairs Manager at LVMH joins us to explore how the FDA, FTC, and even customers shape the cosmetic industry. Hope you enjoy!

]]> The FDA stands for The Food and Drug Administration, but they are also key in regulating the cosmetic industry.  In 1938, The Federal Food, Drug, and Cosmetic Act gave the FDA the responsibility for regulating cosmetics and protecting customers. 

To explore how cosmetics are regulated, Charmain Rodriques, Regulatory Affairs Manager at LVMH joins us to explore how the FDA, FTC, and even customers shape the cosmetic industry. Hope you enjoy!

]]> Aaron & Diane Buzzsprout-9542206 Tue, 16 Nov 2021 05:00:00 -0600 2042 Cosmetics, FDA, Regulations, Advertising, Claims 2 8 full false Intermission: Sue Lancaster --Entrepreneur and Business Developer :) Intermission: Sue Lancaster --Entrepreneur and Business Developer :) After graduating from the University of South Dakota, Sue Lancaster jumped into the local biotech community to help bring a variety of products to market, which has included technologies from two faculty at South Dakota State University. Learn more about her career journey and other fun details on this intermission!      

]]> After graduating from the University of South Dakota, Sue Lancaster jumped into the local biotech community to help bring a variety of products to market, which has included technologies from two faculty at South Dakota State University. Learn more about her career journey and other fun details on this intermission!      

]]> Aaron & Diane Buzzsprout-9505189 Tue, 09 Nov 2021 05:00:00 -0600 429 full false BSE: One Protein, Three Perspectives. BSE: One Protein, Three Perspectives. "Mad Cow Disease" emerged in the United Kingdom in 1986. Named from the symptoms seen in cattle, it was eventually renamed more appropriately to Bovine Spongiform Encephalopathy (BSE). When humans are infected, the disease seen is variant creutzfeldt-jakob disease (vCJD).  

This episode explores the story of how a prion shaped the beef and biotech industries and revealed a failure in questions and ethics.  We are joined by Dr. Fiona Houston (senior researcher and veterinarian), Anne McVey (ethics advocate and mother of a victim), and Kelly Creighton (biologics manufacturing regulatory expert).

Join us to learn how scientists tackle emerging infections, why we need to ask the hard questions, and how this prion has shaped the industry.  

]]> "Mad Cow Disease" emerged in the United Kingdom in 1986. Named from the symptoms seen in cattle, it was eventually renamed more appropriately to Bovine Spongiform Encephalopathy (BSE). When humans are infected, the disease seen is variant creutzfeldt-jakob disease (vCJD).  

This episode explores the story of how a prion shaped the beef and biotech industries and revealed a failure in questions and ethics.  We are joined by Dr. Fiona Houston (senior researcher and veterinarian), Anne McVey (ethics advocate and mother of a victim), and Kelly Creighton (biologics manufacturing regulatory expert).

Join us to learn how scientists tackle emerging infections, why we need to ask the hard questions, and how this prion has shaped the industry.  

]]> Aaron & Diane Buzzsprout-9433733 Tue, 02 Nov 2021 05:00:00 -0500 3187 Mad Cow, BSE, vCJD, Biologics, Quality Assurance, Prion, Biologics, Regulations, FDA 2 7 full false Intermissions: Chris Schilken --Deputy Commissioner of GOED Intermissions: Chris Schilken --Deputy Commissioner of GOED Chris Schilken is the Deputy Commissioner and the Director of Business Development in the South Dakota Governor’s Office of Economic Development. South Dakota has a growing Biotech community and Chris is key to helping businesses connect to state resources to help both startups and larger companies.

He joins us on this intermission as we learn more about him and how he can help.

Learn more or contact the Governor's Office of Economic Development here:
https://sdgoed.com/
goedinfo@state.sd.us

]]> Chris Schilken is the Deputy Commissioner and the Director of Business Development in the South Dakota Governor’s Office of Economic Development. South Dakota has a growing Biotech community and Chris is key to helping businesses connect to state resources to help both startups and larger companies.

He joins us on this intermission as we learn more about him and how he can help.

Learn more or contact the Governor's Office of Economic Development here:
https://sdgoed.com/
goedinfo@state.sd.us

]]> Aaron & Diane Buzzsprout-9419256 Tue, 26 Oct 2021 05:00:00 -0500 584 full false The Lubeck Disaster: Expecting the Unexpected The Lubeck Disaster: Expecting the Unexpected In this episode, we explore a vaccine contamination disaster in the early 1930's Germany. Dr. Gregory Fox, Professor and Pulmonary Physician at the University of Sydney,  joins us to discuss what went wrong, and how expecting the unexpected can alert us that something could be awry.
 
Read Dr. Fox's Paper on the Lubeck Disaster  Here

]]> In this episode, we explore a vaccine contamination disaster in the early 1930's Germany. Dr. Gregory Fox, Professor and Pulmonary Physician at the University of Sydney,  joins us to discuss what went wrong, and how expecting the unexpected can alert us that something could be awry.
 
Read Dr. Fox's Paper on the Lubeck Disaster  Here

]]> Aaron Buzzsprout-9399220 Wed, 20 Oct 2021 06:00:00 -0500 1412 Tuberculosis, Lubeck Disaster, Vaccine Contamination 2 6 full false Intermissions: Joni Ekstrum --Executive Director and Connector for SD Biotech Intermissions: Joni Ekstrum --Executive Director and Connector for SD Biotech South Dakota has a thriving biotech network, thanks largely to Joni Ekstrum, Executive Director for South Dakota Biotech. Joni also helped make this podcast happen.

In this episode we get to know Joni better and learn what Joni likes best about the biotech world and her work with SD Bio. Enjoy!

]]> South Dakota has a thriving biotech network, thanks largely to Joni Ekstrum, Executive Director for South Dakota Biotech. Joni also helped make this podcast happen.

In this episode we get to know Joni better and learn what Joni likes best about the biotech world and her work with SD Bio. Enjoy!

]]> Aaron & Diane Buzzsprout-9312339 Tue, 12 Oct 2021 05:00:00 -0500 368 full false Cargo Cult Quality: Better Science Through Rituals Cargo Cult Quality: Better Science Through Rituals Quality Assurance is all about controlling variation in the midst of science and human behavior.  We have outcomes we want, but sometimes take quirky paths to get there.

We explore this with help from  Dr. Lamont Lindstrom's and "Cargo Cults," a name attributed to social movements from  Melanesian Islanders, and scientists who embraced rituals to improve their research.

We are also joined by Defense Analyst, Dr. Tina Elie, and Neuroscientists Drs. Michael Long and Robert Froemke on this journey to understand and perhaps embrace rituals!

To learn more about Cargo Cults check out Dr. Lindstrom's book:
Amazon
Scholar Space

Dr. Michael Long's Lab
Dr. Robert Froemke's Lab


]]> Quality Assurance is all about controlling variation in the midst of science and human behavior.  We have outcomes we want, but sometimes take quirky paths to get there.

We explore this with help from  Dr. Lamont Lindstrom's and "Cargo Cults," a name attributed to social movements from  Melanesian Islanders, and scientists who embraced rituals to improve their research.

We are also joined by Defense Analyst, Dr. Tina Elie, and Neuroscientists Drs. Michael Long and Robert Froemke on this journey to understand and perhaps embrace rituals!

To learn more about Cargo Cults check out Dr. Lindstrom's book:
Amazon
Scholar Space

Dr. Michael Long's Lab
Dr. Robert Froemke's Lab


]]> Aaron & Diane Buzzsprout-9273038 Tue, 05 Oct 2021 05:00:00 -0500 2422 2 5 full false Intermissions: Megan McCray --Human Factors Student, Pizza Critic Intermissions: Megan McCray --Human Factors Student, Pizza Critic On this intermission, I interview Megan McCray, who moved to South Dakota to study Human Factors Engineering.  Learn about human factors, a dog with excessive toe fur, and more about Megan and her studies in the USD graduate school.

]]> On this intermission, I interview Megan McCray, who moved to South Dakota to study Human Factors Engineering.  Learn about human factors, a dog with excessive toe fur, and more about Megan and her studies in the USD graduate school.

]]> Aaron & Diane Buzzsprout-9226199 Tue, 28 Sep 2021 05:00:00 -0500 453 full false When Milk Goes Bad: With Kate Haiar When Milk Goes Bad: With Kate Haiar In 1909 food buying food came with a risk. Sadly, in a Rhode Island orphanage, 22 infants died from contaminated condensed milk. Today that's unheard of. Why? GMP manufacturing, FSMA, and other quality and regulatory controls. 

Kate Haiar, Quality Director for Regulatory and Audits and Sunbutter Divisions at Red River Commodities joins me to discuss all things food quality. Join us on this episode as we break away from our usual discussions on drugs and devices to explore other areas the FDA regulates.      

]]> In 1909 food buying food came with a risk. Sadly, in a Rhode Island orphanage, 22 infants died from contaminated condensed milk. Today that's unheard of. Why? GMP manufacturing, FSMA, and other quality and regulatory controls. 

Kate Haiar, Quality Director for Regulatory and Audits and Sunbutter Divisions at Red River Commodities joins me to discuss all things food quality. Join us on this episode as we break away from our usual discussions on drugs and devices to explore other areas the FDA regulates.      

]]> Aaron Buzzsprout-9226200 Tue, 21 Sep 2021 05:00:00 -0500 1628 Food Safety, Contamination, Food Quality, FSMA 2 4 full false Intermission: Jeni = 4 Letters for Laughter Intermission: Jeni = 4 Letters for Laughter In this intermission, we interview Jenifer Fjelstad. Jeni is an undergraduate at Augustana University in Sioux Falls and supports the podcast through her internship. Learn more about her on this intermission! 

]]> In this intermission, we interview Jenifer Fjelstad. Jeni is an undergraduate at Augustana University in Sioux Falls and supports the podcast through her internship. Learn more about her on this intermission! 

]]> Aaron Buzzsprout-9190078 Tue, 14 Sep 2021 05:00:00 -0500 727 Augustana University, Intermission 2 full false Primodos: Zebrafish, GLP, and Unanswered Questions Primodos: Zebrafish, GLP, and Unanswered Questions Primodos, a hormone-based pregnancy test, was given to women between 1959 and 1978. Its development occurred before GLP and before standardized testing for teratogenesis (causing birth defects).  There are data and suspicions that it caused birth defects, but more questions remain.

This episode of Inside Out Quality explores the story of this in vivo diagnostic with Dr. Neil Vargesson, from the University of Aberdeen, Scotland, UK. Learn another reason for the importance of Good Laboratory Practices and why pre-clinical studies are key to keeping people safe.

To learn more about Dr. Vargesson's research, visit his site here: Link   

Dr. Vargesson's research  publication discussed on this show: Link 
 

]]> Primodos, a hormone-based pregnancy test, was given to women between 1959 and 1978. Its development occurred before GLP and before standardized testing for teratogenesis (causing birth defects).  There are data and suspicions that it caused birth defects, but more questions remain.

This episode of Inside Out Quality explores the story of this in vivo diagnostic with Dr. Neil Vargesson, from the University of Aberdeen, Scotland, UK. Learn another reason for the importance of Good Laboratory Practices and why pre-clinical studies are key to keeping people safe.

To learn more about Dr. Vargesson's research, visit his site here: Link   

Dr. Vargesson's research  publication discussed on this show: Link 
 

]]> Buzzsprout-9149512 Tue, 07 Sep 2021 05:00:00 -0500 2087 Primodos, Birth Defects, GLP, Zebrafish 2 3 full false Intermission: Hailey Nold our first intern and future therapist Intermission: Hailey Nold our first intern and future therapist Hailey Nold joined Inside Out Quality for season two to help with planning, research, and locating guests. Learn more about Hailey and how she made our work so much fun on this intermission!

]]> Hailey Nold joined Inside Out Quality for season two to help with planning, research, and locating guests. Learn more about Hailey and how she made our work so much fun on this intermission!

]]> Aaron & Diane Buzzsprout-9082742 Tue, 31 Aug 2021 05:00:00 -0500 580 full false Elixir Sulfanilamide and the FD&C Act Elixir Sulfanilamide and the FD&C Act How did a formulation change, turn a life saving drug into a poison? How did tragedy push US lawmakers into passing a new act to regulate Food, Drugs, and Cosmetics? Historian Vanessa Burrows with the FDA joins us to share the story of Elixir Sulfanilamide and the FD&C Act of 1938. This is a story of what can go wrong when morality, science, and businesses are done wrong.

To learn more about the FDA's history check out these sites:
 
www.fda.gov/history

Frances Kelsey’s oral history 

Elixir sulfanilamide sample bottle

Oral Histories 

Video blogs

A synopsis of the Elixir Sulfanilamide tragedy

]]> How did a formulation change, turn a life saving drug into a poison? How did tragedy push US lawmakers into passing a new act to regulate Food, Drugs, and Cosmetics? Historian Vanessa Burrows with the FDA joins us to share the story of Elixir Sulfanilamide and the FD&C Act of 1938. This is a story of what can go wrong when morality, science, and businesses are done wrong.

To learn more about the FDA's history check out these sites:
 
www.fda.gov/history

Frances Kelsey’s oral history 

Elixir sulfanilamide sample bottle

Oral Histories 

Video blogs

A synopsis of the Elixir Sulfanilamide tragedy

]]> Aaron & Diane Buzzsprout-9011692 Tue, 24 Aug 2021 05:00:00 -0500 2714 FDA, History, Elixir, Sulfanilamide, Massengill, Ethylene Glycol, Regulations, Quality Assurance 2 2 full false Intermission: Diane and Nate Vegans in Midwest Intermission: Diane and Nate Vegans in Midwest In season 2 we are bringing you intermissions: short interviews with local professionals and those that help make this podcast happen. We hope you enjoy!

In this intermission, I interview Diane Cox and Nate Poeppel about one of things they have in common: a vegan diet. Join us as we discuss how they chose this diet, why they stick with it, and strategies they employ living in the Midwest. 

]]> In season 2 we are bringing you intermissions: short interviews with local professionals and those that help make this podcast happen. We hope you enjoy!

In this intermission, I interview Diane Cox and Nate Poeppel about one of things they have in common: a vegan diet. Join us as we discuss how they chose this diet, why they stick with it, and strategies they employ living in the Midwest. 

]]> Aaron & Diane Buzzsprout-9026530 Tue, 17 Aug 2021 05:00:00 -0500 744 full false Boeing 737 MAX: Human Factors with Dr. Mica Endsley Boeing 737 MAX: Human Factors with Dr. Mica Endsley In this episode we explore the tragic failure in human factors engineering on the Boeing 737 MAX and why early incorporation of the user’s needs and limitations is key to developing better, safer products. Dr. Mica Endsley, former Chief Scientist of the Air Force and founder of SA Technologies, joins us to discuss Human Factors Engineering and what we can learn from the 737 MAX tragedies.  

Human Factors & Ergonomics Society: www.hfes.org


]]> In this episode we explore the tragic failure in human factors engineering on the Boeing 737 MAX and why early incorporation of the user’s needs and limitations is key to developing better, safer products. Dr. Mica Endsley, former Chief Scientist of the Air Force and founder of SA Technologies, joins us to discuss Human Factors Engineering and what we can learn from the 737 MAX tragedies.  

Human Factors & Ergonomics Society: www.hfes.org


]]> Aaron & Diane Buzzsprout-8891009 Tue, 10 Aug 2021 05:00:00 -0500 2461 Boeing, 737max, HFE, Human Factors, FDA, Quality Assurance, FAA, Regulations, Medical Device Development 2 1 full false A Horse Named Jim: The Biologics Control Act of 1902 A Horse Named Jim: The Biologics Control Act of 1902 In our last episode for season 1, Diane and I dive into the story behind the first US law passed for protecting people from a medical product failure: The Biologics Control Act of 1902. Joining us is René Najera editor of the History of Vaccines (https://www.historyofvaccines.org/). He helps explain the development of diphtheria antitoxin and discusses early product development and public perception.    

Also joining us is Kelly Creighton of Clinipace to discuss how regulations shape product development and help protect patients.

Stay tuned for season 2! 

]]> In our last episode for season 1, Diane and I dive into the story behind the first US law passed for protecting people from a medical product failure: The Biologics Control Act of 1902. Joining us is René Najera editor of the History of Vaccines (https://www.historyofvaccines.org/). He helps explain the development of diphtheria antitoxin and discusses early product development and public perception.    

Also joining us is Kelly Creighton of Clinipace to discuss how regulations shape product development and help protect patients.

Stay tuned for season 2! 

]]> Aaron & Diane Buzzsprout-8251459 Tue, 06 Apr 2021 05:00:00 -0500 3841 Biologics Control Act, QA, Quality Assurance, History of Vaccines 1 10 full false TGN1412 and PMOA –Story of a monoclonal antibody that did the unexpected TGN1412 and PMOA –Story of a monoclonal antibody that did the unexpected In this episode, Diane and I are joined by Husain Attarwala, Head of Pharmacometrics and Clinical Pharmacology at Moderna and author of a paper diving into the 2006 failed clinical trial of TGN1412.  We discuss how things went wrong, and what to consider when planning clinical trials to help keep study participants safe.

Kelly Creighton, VP for Regulatory and Strategic Development at Clinipace also joins us to discuss the importance of understanding the Primary Mechanism of Action (PMOA) of biologics and FDA expectations.  

]]> In this episode, Diane and I are joined by Husain Attarwala, Head of Pharmacometrics and Clinical Pharmacology at Moderna and author of a paper diving into the 2006 failed clinical trial of TGN1412.  We discuss how things went wrong, and what to consider when planning clinical trials to help keep study participants safe.

Kelly Creighton, VP for Regulatory and Strategic Development at Clinipace also joins us to discuss the importance of understanding the Primary Mechanism of Action (PMOA) of biologics and FDA expectations.  

]]> Aaron & Diane Buzzsprout-8191695 Tue, 23 Mar 2021 05:00:00 -0500 3007 TGN1412, Biologics, PMOA, FDA, Quality Assurance, GCP, Regulations 1 9 full false A Case of Counterfeit Rabies Vaccines and Supply Chain Risk A Case of Counterfeit Rabies Vaccines and Supply Chain Risk We are all familiar with counterfeit money, but what happens when your vaccine supply is counterfeit? In this episode, Diane and I interview Dr. Karl Henson from The Medical City hospital in Pasig City of the Philippines. He shares their story of both identifying the counterfeit rabies vaccines that were injected into patients and the steps they took to prevent it from happening again.

To read their report: Counterfeit Rabies Vaccines: The Philippine Experience https://pubmed.ncbi.nlm.nih.gov/32855990/

We are also joined by Daniel Stanton, President and Co-Founder of SecureMarking and author of Supply Chain Management for Dummies, and Mark Manning, Founder and CEO of iTrace Technologies. We discuss the impact of counterfeit goods on company revenue, and in the case of counterfeit pharmaceuticals and medical devices, the potentially dire consequences to patient health. Daniel and Mark educate us on how counterfeit products enter the supply chain and what technologies are available to help manufacturers, including biotech companies, prevent it.

To reach out to Mark or Daniel:
http://itracetech.com/

http://www.securemarking.com/    


]]> We are all familiar with counterfeit money, but what happens when your vaccine supply is counterfeit? In this episode, Diane and I interview Dr. Karl Henson from The Medical City hospital in Pasig City of the Philippines. He shares their story of both identifying the counterfeit rabies vaccines that were injected into patients and the steps they took to prevent it from happening again.

To read their report: Counterfeit Rabies Vaccines: The Philippine Experience https://pubmed.ncbi.nlm.nih.gov/32855990/

We are also joined by Daniel Stanton, President and Co-Founder of SecureMarking and author of Supply Chain Management for Dummies, and Mark Manning, Founder and CEO of iTrace Technologies. We discuss the impact of counterfeit goods on company revenue, and in the case of counterfeit pharmaceuticals and medical devices, the potentially dire consequences to patient health. Daniel and Mark educate us on how counterfeit products enter the supply chain and what technologies are available to help manufacturers, including biotech companies, prevent it.

To reach out to Mark or Daniel:
http://itracetech.com/

http://www.securemarking.com/    


]]> Aaron & Diane Buzzsprout-8072316 Tue, 09 Mar 2021 05:00:00 -0600 4143 Counterfeit, Supply Chain, FDA, Regulations, Philippines FDA, Sanofi, Rabies Vaccine 1 8 full false The 1983 Air Canada Incident and Design Controls The 1983 Air Canada Incident and Design Controls Diane and I explore an Air Canada incident where a flight ran out of fuel at 40,000 feet in the air. Retired United Airlines Captain Sam Biondo joins us to talk us through aviation safety and this incident. Diane and I are also joined by Joe Ostendorf, a medical device regulatory consultant to discuss design controls and how they can prevent your product develop from running out of fuel.

If you are interested in reaching out to Joe, he can be reached at joseph@ostendorfconsultingllc.com  

 

]]> Diane and I explore an Air Canada incident where a flight ran out of fuel at 40,000 feet in the air. Retired United Airlines Captain Sam Biondo joins us to talk us through aviation safety and this incident. Diane and I are also joined by Joe Ostendorf, a medical device regulatory consultant to discuss design controls and how they can prevent your product develop from running out of fuel.

If you are interested in reaching out to Joe, he can be reached at joseph@ostendorfconsultingllc.com  

 

]]> Aaron & Diane Buzzsprout-7999924 Tue, 23 Feb 2021 05:00:00 -0600 5028 Air Canada, Gimli Glider, Bob Pearson, Design Controls, Risk Management 1 7 full true Thalidomide --The Drug and Woman That Changed the FDA Forever Thalidomide --The Drug and Woman That Changed the FDA Forever In the late 1950's a new drug was launched in Europe. Clinical trials weren't like they are today; as a result, thousands of children suffered from extreme birth defects or died before birth due to Thalidomide. Frances Kelsey, a new FDA reviewer, pushed for safety data before allowing it to be approved US,  and spared the US from tragedy.  

We are joined by Neil Vargesson, Chair in Developmental Biology and expert in Thalidomide, as we discuss the drug's history and how it caused birth defects. Justine Peterson, P.A., joins us also to give a clinical perspective on drugs, trials, and how they shape her world. 

]]> In the late 1950's a new drug was launched in Europe. Clinical trials weren't like they are today; as a result, thousands of children suffered from extreme birth defects or died before birth due to Thalidomide. Frances Kelsey, a new FDA reviewer, pushed for safety data before allowing it to be approved US,  and spared the US from tragedy.  

We are joined by Neil Vargesson, Chair in Developmental Biology and expert in Thalidomide, as we discuss the drug's history and how it caused birth defects. Justine Peterson, P.A., joins us also to give a clinical perspective on drugs, trials, and how they shape her world. 

]]> Aaron & Diane Buzzsprout-7514401 Tue, 09 Feb 2021 05:00:00 -0600 3883 Thalidomide, Birth Defects, FDA, Francis Kelsey, Harris, Kefauver, Pharmacology, Harold Evans 1 6 full false Rotateq and Rotarix -A story of vaccine contamination and prevention Rotateq and Rotarix -A story of vaccine contamination and prevention In 2010, two companies learned their vaccines for a childhood infection (rotavirus) had another virus present: porcine circovirus. Both companies couldn't detect the virus lurking in a key material used for vaccine manufacture, and it went undetected until an academic lab discovered with new technology. 

Virologist and Vaccine Developer Dick Hesse from Kansas State University joins me and Diane to discuss vaccine contamination.  We are also joined by Julia Schaar with Medgene Labs (https://www.medgenelabs.com/) a local livestock vaccine developer to share best practices for preventing product contamination.  

]]> In 2010, two companies learned their vaccines for a childhood infection (rotavirus) had another virus present: porcine circovirus. Both companies couldn't detect the virus lurking in a key material used for vaccine manufacture, and it went undetected until an academic lab discovered with new technology. 

Virologist and Vaccine Developer Dick Hesse from Kansas State University joins me and Diane to discuss vaccine contamination.  We are also joined by Julia Schaar with Medgene Labs (https://www.medgenelabs.com/) a local livestock vaccine developer to share best practices for preventing product contamination.  

]]> Aaron & Diane Buzzsprout-6703639 Tue, 26 Jan 2021 05:00:00 -0600 3127 Vaccines, Contamination, PCV, Swine, FDA, Regulations, Quality Assurance, Rotavirus, Rotateq, Rotarix 1 5 full false The 2013 Baxter Mold Incident --Lessons in HEPA Filtration The 2013 Baxter Mold Incident --Lessons in HEPA Filtration In 2011, Chris Wall, an HVAC technician at a Baxter Healthcare manufacturing site in North Carolina inspected the HEPA filters in a room where sterile Saline IV Bags were filled. He found them to be contaminated with mold. Management stopped him from changing them for 2 years, until he finally reached for help to the FDA. The result was a warning letter and 18 million dollar fine. 

In this episode, Diane and I meet with Tony Lee of AT Analytical (http://www.atanalytical.com/) to discuss the 2013 incident of mold contamination, and how to prevent mold contamination and ensure customer safety.   


]]> In 2011, Chris Wall, an HVAC technician at a Baxter Healthcare manufacturing site in North Carolina inspected the HEPA filters in a room where sterile Saline IV Bags were filled. He found them to be contaminated with mold. Management stopped him from changing them for 2 years, until he finally reached for help to the FDA. The result was a warning letter and 18 million dollar fine. 

In this episode, Diane and I meet with Tony Lee of AT Analytical (http://www.atanalytical.com/) to discuss the 2013 incident of mold contamination, and how to prevent mold contamination and ensure customer safety.   


]]> Aaron & Diane Buzzsprout-6922001 Tue, 12 Jan 2021 05:00:00 -0600 2030 Baxter Health, HEPA Filters, AT Analytical, FDA, Warning Letter, DOJ Fine, Quality Assurance 1 4 full false Conversation with Adam Litwin M.D. --Personnel Qualification Conversation with Adam Litwin M.D. --Personnel Qualification This episode explores the story of two individuals charged with impersonating a physician. One, Gerald Barnes, had motivations of money and caused the death of John Mckenzie. The other, Adam Litwin, had a passion for medicine, caused no harm, and later completed medical school and is now a physician. The difference was engagement and passion for medicine. 

Quality systems require that employees are qualified. Diane and I discuss this with Adam Litwin M.D. and Bill McGuckin of Oxenham Group (https://oxenhamgroup.com/).  

]]> This episode explores the story of two individuals charged with impersonating a physician. One, Gerald Barnes, had motivations of money and caused the death of John Mckenzie. The other, Adam Litwin, had a passion for medicine, caused no harm, and later completed medical school and is now a physician. The difference was engagement and passion for medicine. 

Quality systems require that employees are qualified. Diane and I discuss this with Adam Litwin M.D. and Bill McGuckin of Oxenham Group (https://oxenhamgroup.com/).  

]]> Aaron & Diane Buzzsprout-6670631 Tue, 29 Dec 2020 05:00:00 -0600 3834 Personnel, FDA, Quality Assurance, Regulations, Physicians 1 3 full false NASA and the SAPA Investigation --Supplier Management NASA and the SAPA Investigation --Supplier Management In this episode, Diane and I interview Special Agent Wade Krieger from NASA's Office of Inspector General. He shares insight and lessons learned from the investigation into supplier fraud from SAPA Materials (https://www.nasa.gov/press-release/nasa-investigation-uncovers-cause-of-two-science-mission-launch-failures).

We also discuss best practices in investigations and supplier management with Lindsey Marshall from OmegaQuant (https://omegaquant.com/), a Sioux Falls company ranked in the Inc. 5,000 list.    

]]> In this episode, Diane and I interview Special Agent Wade Krieger from NASA's Office of Inspector General. He shares insight and lessons learned from the investigation into supplier fraud from SAPA Materials (https://www.nasa.gov/press-release/nasa-investigation-uncovers-cause-of-two-science-mission-launch-failures).

We also discuss best practices in investigations and supplier management with Lindsey Marshall from OmegaQuant (https://omegaquant.com/), a Sioux Falls company ranked in the Inc. 5,000 list.    

]]> Aaron & Diane Buzzsprout-6570658 Thu, 26 Nov 2020 14:00:00 -0600 3515 NASA, SAPA, Supplier Fraud, Product Substitution, Quality Assurance, FDA 1 2 full false Starting Out In Quality -Management Matters Starting Out In Quality -Management Matters In this episode, Diane and I discuss challenges small companies face when developing a quality system, and when it can go wrong. We also interview Stephanie Armstead, Director of Quality at Prairie Aquatec, a growing new company in Brookings, South Dakota (https://www.prairieaquatech.com/).

]]> In this episode, Diane and I discuss challenges small companies face when developing a quality system, and when it can go wrong. We also interview Stephanie Armstead, Director of Quality at Prairie Aquatec, a growing new company in Brookings, South Dakota (https://www.prairieaquatech.com/).

]]> Aaron & Diane Buzzsprout-6570589 Thu, 26 Nov 2020 14:00:00 -0600 3112 Quality Assurance, Leadership, Regulations, GMP, FDA 1 1 full false