Apr 23, 2019
Welcome to the 19th 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 week, Mandy is bringing you the fifth part of the six-part series focused around quality culture, the virtual pharma environment, and supply chain management. As always, she is joined by her veteran guest of the series, Lisa Helmonds!
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 will be discussing management review and quality metrics. Lisa explains what a management review is, the overall goal of it, what her recommendations are in terms of the type of quality metrics that should be reviewed during the meeting, and how it is important in sustaining a quality culture.
Be sure to keep tuning in for future episodes to hear the last part in the series with Lisa Helmonds!
Key Takeaways:
[:29] About today’s episode.
[1:03] Lisa Helmonds introduces herself and gives some background on her career.
[2:26] About today’s topic: management review and quality metrics.
[2:42] What is management review?
[3:56] Who typically attends a management review from the various functions in the organization?
[5:18] What’s the overall goal of a management review?
[8:23] Is a management review required or is it voluntary?
[12:02] What Lisa would recommend in terms of the type of quality metrics that should be reviewed during this meeting.
[15:53] How Lisa sees management review as important in sustaining a quality culture.
[22:39] About the last part of the series!
[23:46] If you have any questions, requests, or suggestions, you can contact Mandy Gervasio at Mandy.Podcast@Solabs.com. If you have any questions for Lisa Helmonds, you can contact her on LinkedIn.