Welcome to episode 2 of the 6-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.
Last week’s episode focused on the details of what a virtual company looks like, and the unique advantages and challenges to consider in the virtual framework. In this week’s episode, Lisa, Philippe, and Mandy are diving even deeper into the topic, and discussing qualifications and oversight of contract service providers.
Be sure to keep tuning in for future episodes to hear the next four parts in the series!
[:24] About today’s episode.
[1:25] Lisa describes the topic for this week’s episode and talks a bit about her background in life sciences.
[3:24] Why is the qualification of contract service providers important to managing quality?
[6:21] What qualification of a contract service provider entails.
[11:06] Tools that are available to determine which contract service providers should be audited along with the frequency of those audits.
[15:15] What responsibility does a sponsor have with regard to contract service provider oversight?
[20:53] About the third episode in the six-part series.
Mentioned in this Episode:
ICH.org - Q7 Good Manufacturing Practice Guide
ICH.org - Q8 Pharmaceutical Development
ICH.org - Q9 Quality Risk Management
ICH.org - Q10 Pharmaceutical Quality System
Failure Mode and Effects Analysis (FMEA)
Failure Mode, Effects, and Criticality Analysis (FMECA) Fault Tree Analysis (FTA)
Hazard Analysis and Critical Control Point (HACCP)
Hazard and Operability Study (HAZOP)
Preliminary Hazard Analysis (PHA)
Lisa Helmonds (LinkedIn)