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: 

Lisa Helmonds on LinkedIn

MWA Consulting

BioMarin

Genentech

U.S. Food and Drug Administration (FDA)

FDA - Form 483 Warning Letter or Inspection Observation

FDA - Guidance Documents

Application to be on the show: From Lab to Launch

Qualio

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