Latest Quality assurance Podcast Episodes
Global Regulatory Standards
RCA Radio - December 19, 2023 21:00 - 22 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder, Regulatory Compliance Associates'® (RCA) Regulatory Expert. Kinga Demetriou, an Expert Certifier at BSI, and Nathan Shipley, a Global Certification Manager at BSI to discuss the current trends and challenges with Regula...
The Therapeutic Power of Stories.
Inside Out Quality - June 06, 2023 10:00 - 35 minutes ★★★★★ - 6 ratings“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 ...
Keeping Radiation Safe: Todd Pawlicki and LINACs
Inside Out Quality - May 16, 2023 10:00 - 43 minutes ★★★★★ - 6 ratingsGordon 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 (LINA...
Therac 25 in the Classroom with Natalia Silvis-Cividijian
Inside Out Quality - May 02, 2023 10:00 - 49 minutes ★★★★★ - 6 ratingsScott 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 br...
Therac 25 in the Classroom with Natalia Silvis-Cividjian
Inside Out Quality - May 02, 2023 10:00 - 49 minutes ★★★★★ - 6 ratingsScott 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 br...
Science and (Quality) is About Questions
Inside Out Quality - March 08, 2023 11:00 - 31 minutes ★★★★★ - 6 ratingsIn 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 c...
Technical Program Management
RCA Radio - February 24, 2023 18:00 - 9 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Eric Januszewski, Senior Director of Client Relations for US and Europe, at Regulatory Compliance Associates® (RCA) to talk about outsourced technical program management and the increased demand caused by the shortage of qualified su...
2023 Industry Outlook - Pharmaceutical
RCA Radio - January 25, 2023 16:00 - 26 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller, Steve Lynn, and Susan Schniepp explore what is happening in the Pharmaceutical industry in 2023 and provide you with insight on how to prepare yourself for these upcoming initiatives. Steve is Regulatory Compliance Associates® (RCA) Executive ...
The Opioid Crisis: The role of sales with Alec Burlakoff
Inside Out Quality - January 03, 2023 11:00 - 42 minutes ★★★★★ - 6 ratingsIn 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 r...
Speaking of Quality... Actress Michelle Hutchison
Inside Out Quality - December 20, 2022 11:00 - 44 minutes ★★★★★ - 6 ratingsMichelle 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 tal...
Speaking of Quality...Quality Assurance Contributing to the Bottom Line with Bart Bosch
Inside Out Quality - December 06, 2022 11:00 - 30 minutes ★★★★★ - 6 ratingsEarlier 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 Q...
Orkin Helps Us Think Like a Cockroach
Inside Out Quality - November 22, 2022 11:00 - 39 minutes ★★★★★ - 6 ratingsIn 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 contro...
Gabriel Licina: From Biohacker to Independent Researcher
Inside Out Quality - November 08, 2022 11:00 - 45 minutes ★★★★★ - 6 ratingsGabriel 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 regulati...
Mrs. Winslow's Soothing Syrup
Inside Out Quality - October 24, 2022 10:00 - 35 minutes ★★★★★ - 6 ratings“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. W...
Yugo: Power in a Reputation, Not the Car.
Inside Out Quality - October 11, 2022 10:00 - 53 minutes ★★★★★ - 6 ratingsJason 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 fo...
DHF & Design Control
RCA Radio - July 26, 2022 15:00 - 14 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Jessica Schafersman, Biomedical Engineer, Project Management Professional, and Certified Usability Analyst at Regulatory Compliance Associates® (RCA) to talk about Design controls and the proper way to go about developing your DHF fo...
What is Irritation and Sensitization?
RCA Radio - June 10, 2022 20:00 - 27 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Audrey Turley, Matt a board-certified toxicologist with a Ph.D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Audrey is a Nelson Labs Senior Biocompatibility Expert. Listen i...
Outsourcing and Staff Augmentation
RCA Radio - May 26, 2022 19:00 - 14 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Erica Porcelli, CEO of Regulatory Compliance Associates® (RCA), to going to over outsourcing leadership roles and how companies use staff augmentation to jump-start their teams. Listen in as we talk about what outsourced leadership ...
What is ISO 13485?
RCA Radio - May 03, 2022 15:00 - 13 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory Compliance Associates (RCA) to cover the Medical Device quality standard ISO 13485 and why it is important for the industry. Listen in as Jordan goes over the background of ...
What is Cytotoxicity?
RCA Radio - February 21, 2022 23:00 - 30 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel, Matt a board-certified toxicologist with a Ph.D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Helin is Nelson Labs Senior Biocompatibility Expert with a Ph....
2022 Industry Outlook - Pharmaceutical
RCA Radio - January 25, 2022 14:00 - 22 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller and Steve Lynn, who is Regulatory Compliance Associates® Inc. (RCA) Executive VP of Pharmaceuticals, explore what is happening in the Pharmaceutical industry in 2022 and provide you with insight on how to prepare yourself for these upcoming ini...
Intro to Pre-Clinical Testing and Biocompatibility
RCA Radio - January 20, 2022 15:00 - 32 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel, Matt a board-certified toxicologist with a Ph.D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Helin is Nelson Labs Senior Biocompatibility Expert with a Ph....
Emotions in Quality: De-escalation and a Tribute
Inside Out Quality - January 13, 2022 04:00 - 43 minutes ★★★★★ - 6 ratingsQuality 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 ...
Emotions in Quality: De-escalation and a Tribute
Inside Out Quality - January 13, 2022 04:00 - 43 minutes ★★★★★ - 6 ratingsQuality 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 ...
2022 Industry Outlook - Medical Device
RCA Radio - January 04, 2022 15:00 - 32 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host Brandon Miller, Seyed Khorashahi, and Thor Rollins explore what is happening in the medical device industry in 2022 and provide you with insight on how to prepare yourself for these upcoming initiatives. Seyed is Regulatory Compliance Associates® Inc. (RCA) Exe...
After The Warning Letter with FDA Attorney Amanda Johnston.
Inside Out Quality - December 28, 2021 14:00 - 23 minutes ★★★★★ - 6 ratingsWarning 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 b...
Intermission: Shannon Van Buskirk --SD Bio Member Relations Specialist
Inside Out Quality - November 30, 2021 11:00 - 15 minutes ★★★★★ - 6 ratingsOn 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 defin...
Intermission: Aaron Harmon --Reversing Roles with Joni
Inside Out Quality - November 23, 2021 11:00 - 5 minutes ★★★★★ - 6 ratingsIn 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 intervie...
The Beauty of Regulations
Inside Out Quality - November 16, 2021 11:00 - 34 minutes ★★★★★ - 6 ratingsThe 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...
Laboratory Out-of-Specification Investigations
RCA Radio - November 09, 2021 15:00 - 29 minutes ★★★★★ - 11 ratingsIn this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Senior Director of Quality Control and Consulting Services, Walter Mason, take a deep dive into laboratory Out-of-Specification (OOS) investigations and how to get to the root cause. Listen in as we g...
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