Episode 15: Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA consulting
Automating Quality12 Feb 2019

Episode 15: Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA consulting

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!

Key Takeaways:

[: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:

FDA.gov

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)

Mandy.Podcast@Solabs.com

Episoder(64)

Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam

Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This episode is the second in a series on Inspection Readiness fea...

4 Jun 202418min

Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam

Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, we discuss a topic key to the heart of most quali...

7 Mai 202415min

Episode 54: Risk Management Tools and Techniques with Michael Tyo

Episode 54: Risk Management Tools and Techniques with Michael Tyo

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a di...

6 Feb 202415min

Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo

Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo discusses how warning letters c...

9 Jan 202418min

Episode 52: Supplier Quality Management w. Mandy Gervasio

Episode 52: Supplier Quality Management w. Mandy Gervasio

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by  Philippe Gaudreau, CEO at SOLABS, and Mand...

28 Nov 202317min

Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio

Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS and Mandy ...

17 Okt 202320min

Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve

Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this very specia...

1 Aug 202316min

Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve

Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! ...

4 Jul 202316min

Populært innen Business og økonomi

stopp-verden
lydartikler-fra-aftenposten
dine-penger-pengeradet
e24-podden
rss-penger-polser-og-politikk
rss-borsmorgen-okonominyhetene
pengepodden-2
utbytte
pengesnakk
livet-pa-veien-med-jan-erik-larssen
rss-sunn-okonomi
tid-er-penger-en-podcast-med-peter-warren
morgenkaffen-med-finansavisen
lederpodden
okonomiamatorene
finansredaksjonen
rss-markedspuls-2
stormkast-med-valebrokk-stordalen
rss-andelige-tanker-med-camillo
rss-finanslunsj