Regulations Rx

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/

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 [email protected]

https://www.vlitix.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

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/

“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 

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

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.

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/ 

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.

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.