Automating Quality
by SOLABS, Mandy Gervasio, Philippe Gaudreau, and GuestsWelcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing issues in the space and hear best in class thought leadership on various topics such as Quality, Training and Regulatory Compliance driven from an automation lens.
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Episodes
Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam
15m · PublishedWelcome 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?
Episode 54: Risk Management Tools and Techniques with Michael Tyo
15m · PublishedWelcome 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 [email protected]
Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo
18m · PublishedWelcome 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 [email protected]
Episode 52: Supplier Quality Management w. Mandy Gervasio
17m · PublishedWelcome 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?
Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio
20m · PublishedWelcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. 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 [email protected]
Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve
16m · PublishedWelcome 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 [email protected]
Contact us at [email protected]
Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve
16m · PublishedWelcome 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!
We are joined today by Jamie Villeneuve, Owner and Head of Software Development at NexGen Analytics. Jamie will discuss the design of analytics from establishing the organization's goals to providing the right information to the right people at the right time.
Key Takeaways
01:58 Introducing today’s guest: Jamie Villeneuve from NexGen Analytics
03:19 Who needs information from analytics in an organization?
05:36 How do you know what information is relevant to report on?
08:52 How do you communicate analytics effectively to all staff at a company?
11:40 Is there a process to review metrics over time and ensure what is measured stays up to date with the company’s needs?
15:12 Thank you to Jamie for joining us!
Contact Jamie at [email protected]
Contact us at [email protected]
Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia
14m · PublishedWelcome 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!
We are joined today by return guest Joseph Silvia, Director, Software Quality Training, and Instructor at Oriel STAT A MATRIX. In this episode, Joe shares his expertise on Supplier Management Quality for the medical devices industry. We discuss the onboarding process of new suppliers, the future of remote versus on-site audits, and more!
Key Takeaways
00:38 Introducing Joseph Silvia and Oriel STAT A MATRIX
02:53 Who are the main parties involved in the medical devices supply chain?
04:15 What is the process to getting a new supplier on board?
07:56 Are all audits in the future going to be remote?
10:04 Do suppliers change their processes to make themselves easier to audit?
12:55 Thanks to Joseph and our listeners for this great episode!
Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia
19m · PublishedWelcome 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!
Our guest today is Joseph Silvia, Director, Software Quality Training and Instructor at Oriel STAT A MATRIX. Joe shares his expertise on the Case for Quality, what to focus on first when implementing a quality system and the differences between Computer Software Validation (CSV) and Computer Software Assurance (CSA), and more!
Key Takeaways
02:17 Introducing today’s guest: Joseph Silvia, Director of Software Quality Training and Instruction and Lead Auditor at Oriel Stat A Matrix
03:33 What is the Case for Quality?
05:23 Joseph discusses the importance of having quality at the core of what you do as opposed to adding it as an afterthought
07:44 What is the first thing you should focus on when implementing a quality system?
10:55 Philippe shares his experience on implementing QM10 at SOLABS as part of our quality practices
12:53 The difference between Computer Software Validation (CSV) and Computer Software Assurance (CSA) and how this is impacting risk management
17:38 Thanking Joseph and our listeners for today’s episode!
Contact Joseph at [email protected] or on LinkedIn
Oriel STAT A MATRIX: www.orielstat.com
Reach out to us at [email protected]
Episode 46 - Defining Data Quality with Steve Gens
17m · PublishedWelcome to 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!
Today's episode features Steve Gens, Managing Partner at Gens & Associates. We will define data quality, what happens if the confidence in data quality is low, and provide some recommendations to keep it high.
Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021.
Key Takeaways
00:49 Introducing today’s guest: Steve Gens, here to discuss Data Quality with us
02:10 Defining Data Quality?
04:00 What happens when the confidence in the data quality is low?
05:48 Steve provides some recommendations related to Data Quality.
10:30 How does Data Quality bring Quality and Regulatory together?
13:26 what are some services Gens & Associates offer related to this topic?
Reach out to us at [email protected]
Automating Quality has 55 episodes in total of non- explicit content. Total playtime is 22:27:40. The language of the podcast is English. This podcast has been added on August 20th 2022. It might contain more episodes than the ones shown here. It was last updated on May 19th, 2024 04:42.
