Today’s guest is Lisa Helmonds, Vice President of Quality Services and Operations at MWA Consulting, which helps companies bring life-saving products to market and scale successfully.
Lisa has more than 30 years of training in the areas of manufacturing and quality assurance for the pharmaceutical, biotechnology, and medical device industries. Also, she has extensive "good practice" (GxP) knowledge of quality guidelines and regulations. She works with several startups and established companies to implement or improve quality systems and procedures.
Lisa understands the challenges that industries deal with today. She describes a day-in-the-life of a quality consultant, innovations, and advice to life science entrepreneurs everywhere. Lisa has seen it all and offers some useful takeaways from her insights.
Show Notes:
U.S. Food and Drug Administration (FDA)
FDA - Form 483 Warning Letter or Inspection Observation
Application to be on the show: From Lab to Launch
Music by keldez
Qualio website:
https://www.qualio.com/
Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast
Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8
Music by keldez