Automating Quality SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests

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 quality professionals: inspection readiness! Our guest Caroline Guay-Adam discusses inspection readiness and how to reach and maintain an inspection-ready state over time.
Caroline Guay-Adam has over 15 years of experience as a quality professional before joining Skillpad as a Senior Compliance Consultant. She has plenty to share on compliance and has recently been helping clients implement strategies for being and staying inspection-ready.
 
Key Takeaways:
00:42 Introducing today’s guest: Caroline Guay-Adams
03:23 Why is inspection readiness necessary for Life Sciences companies?
05:24 How do you establish a strategy to be and stay inspection-ready?
08:00 What are the requirements for a company to call itself inspection-ready?
13:00 Which mindset is necessary for this strategy to remain successful over time?

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 discussion on risk management tools. They discuss the importance of a risk plan and a risk assessment SOP, plus the FDA’s expectations regarding the use of risk assessment tools.
 
Key Takeaways:
01:11 Introducing Michael and his Background
02:31 Does the FDA have a clear expectation for the use of risk assessment tools?
06:13 The importance of a risk plan
09:20 Why companies must all have an SOP for risk assessment
Contact us at solabs-podcast@solabs.com

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 can be leveraged as a source of information on the FDA’s current areas of focus and how monitoring them can help avoid the FDA’s attention.
 
Key Takeaways
01:04: Michael introduces himself and his background
02:21: How can companies use warning letters as a source of information on the FDA’s current area of focus
04:31: Michael shares a statistical analysis he conducted on warning letters in 2023
08:52: How warning letters give you an idea of what happened at the company
12:31: Understanding warning letters helps companies avoid the FDA’s attention
Contact us at solabs-podcast@solabs.com

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 Gervasio, VP of QA and Compliance at Comanche Biopharma.
 
In this episode, Mandy and Philippe discuss supplier management from establishing a relationship with new suppliers to maintaining this relationship and keeping the trust between your two organizations alive.
 
Key Takeaways:
01:30 Mandy discusses her current role and how it is linked to supplier management
03:40 Being able to work with partners that allow you to operate as one team in a seamless way is an incredible success factor
04:37 Mandy points red flags when entering a relationship with a supplier
07:15 Communicating only when there are problems to manage is a risky behavior
09:03 From a GCP perspective, how can you establish a good relationship with CROs and other suppliers?
13:26 How do you maintain your relationship with those suppliers and keep the trust alive and active?

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 Gervasio, VP of QA and Compliance at Comanche Biopharma.
 
In this episode, we explore Mandy’s takeaways from recent quality conferences she attended, from management accountability to the importance of managing data integrity.
 
Key Takeaways
02:06: What are the key conferences Mandy attended this year?
04:49: The importance of keeping management accountable for quality objectives.
06:24: Accountability now revolves around individual responsibilities.
10:21: Data integrity is a recurring theme in discussions.
14:30: Training on data integrity has evolved in recent years.
16:07: Supplier Management is another important topic.
 
Contact us at solabs-podcast@solabs.com

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 special 50th episode!
We are joined today by Jamie Villeneuve, CEO and Head of Software Development at NexGen Analytics. Jamie will discuss the common challenges GMP shopfloor companies have in terms of analytics, how this evolved over time, and more!
 
Key Takeaways
01:01 Introducing today’s return guest: Jamie Villeneuve from NexGen Analytics
02:35 What are some of the common challenges in GMP companies from an analytics standpoint?
05:01 What departments need input from analytics?
07:31 How has analytics evolved over time for GMP companies?
10:11 New nomenclature and approach for analytics
11:38 Why do companies invest more and more in analytics?
13:03 The top 5 metrics GMP shopfloor analytics companies need to track
14:42 Thank you to Jamie for joining us for this special episode #50!
Contact Jamie at jvilleneuve@solabs.com
Contact us at solabs-podcast@solabs.com