Regulations Rx

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 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.   

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/).  

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 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/).