Welcome to the 17th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
This will be the third part in the six-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry.
Today, Mandy and Lisa are discussing quality agreements for this third installment in the series. Lisa provides some great insight into quality agreements and why they’re such a critical part of compliance and the supplier quality function. She also shares some great tips for employing these agreements in your own organizations and key things to consider in the process.
Be sure to keep tuning in for future episodes to hear the next three parts in the series!
[:33] About today’s episode.
[1:20] Lisa talks about her experience in the life sciences space.
[3:28] What is a quality agreement? And why is it needed?
[5:09] What information should a quality agreement contain?
[6:44] Some of the main advantages of executing a quality agreement.
[9:03] How a quality agreement is different from a technical or commercial master service agreement.
[20:05] How often should quality agreements be reviewed and revised?
[23:35] Lisa and Mandy close out this week’s podcast! Be sure to continue to tune in for the next three parts of the series! If you have any questions or requests for the show, email Mandy at Mandy.Podcast@Solabs.com. If you have any questions for Lisa, contact her on her LinkedIn.
Mentioned in this Episode:
Part 2: “Qualifications and Oversight of Contract Service Providers with Lisa Helmonds”
Part 1: “Key Elements of Virtual Life Sciences Companies with Lisa Helmonds”
Lisa Helmonds (LinkedIn)