Automating Quality
SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests
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Top 10 Automating Quality Episodes
Goodpods has curated a list of the 10 best Automating Quality episodes, ranked by the number of listens and likes each episode have garnered from our listeners. If you are listening to Automating Quality for the first time, there's no better place to start than with one of these standout episodes. If you are a fan of the show, vote for your favorite Automating Quality episode by adding your comments to the episode page.
07/09/24 • 16 min
Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the first in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. We explore the history of SBOM, its current importance for the FDA, and how to ensure you have an SBOM in place when implementing or developing medical devices.
"Joseph is the CEO of MedWareCyber, a consulting firm specializing in FDA readiness, cybersecurity, and software readiness for the medical devices industry. He is extremely knowledgeable about the regulatory landscape, and we frequently refer to him for his regulatory expertise.
Key Takeaways
01:10 Introducing today’s guest: Joseph Silvia
02:35 What is an SBOM?
04:24 What is the history of SBOM?
05:50 Now, the government is getting involved and SBOM is picking up steam.
06;35 What is the FDA’s expectation on this topic for the medical devices industry?
09:03 When implementing or developing a device, how do you ensure that you have an SBOM in place to support it?
11:38 Who is responsible for SBOM within organizations?
14:37 Where can listeners learn more about this topic?
Reach Joseph at [email protected]
Contact us at [email protected]
11/26/19 • 29 min
Welcome to the 30th 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!
Today’s episode is all about inspection readiness and distinguishing what that looks like from both the GMP side and the GCP side. And joining Mandy today is return guest, Nathalie Bourgouin! Nathalie is the Vice-President of Compliance at Skillpad — a sister company of SOLABS — where she leads the Compliance Consulting Group, with a focus on clinical trials and research compliance. She’s a very well-rounded, highly experienced expert in the space with more than 25 years of experience in pharmaceuticals and biotech!
In this episode, Nathalie highlights the key concepts regarding GxP inspection readiness, compares the differences between GMP and GCP inspection readiness programs, explains how a company can better prepare for an inspection, and even highlights some of the issues she often sees coming up in inspections.
Whether you are new to the life sciences space or are a veteran with many years of experience, you will gain something of value in today’s episode!
Key Takeaways:
[:28] About today’s episode!
[2:35] Mandy welcomes Nathalie to the podcast!
[2:46] Nathalie highlights key concepts regarding GxP inspection readiness.
[4:14] Nathalie compares GMP vs. GCP inspection readiness programs.
[5:05] How can a company get ready for an inspection?
[7:59] Nathalie highlights some of the issues that she commonly sees coming up in GMP regulatory inspections.
[12:42] How GCP inspections differ from GMP inspections as well as some of the key differences in the inspection process between the United States and Canada.
[18:59] Nathalie provides some key tips for preparing for an inspection.
[21:23] Nathalie’s tips for preparing individuals on your team for an inspection.
[24:45] Nathalie stresses the importance of identifying who your key people will be for the inspection and training them on what they should and should not say.
[27:50] Mandy thanks Nathalie for her input on the show and reflects on some of the key learnings.
Mentioned in this Episode:
Automating Quality Ep. 8: “The Specificities of GCP Quality Systems with Nathalie Bourgouin”
Episode 20: Investigation Deviations and Non-Conformances with Lisa Helmonds Vice President from MWA Consulting
Automating Quality
05/07/19 • 33 min
Welcome to the 20th 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 wrapping up the six-part series focused around quality culture, the virtual pharma environment, and supply chain management; with Lisa Helmonds, the Vice President of MWA Consulting. She is also joined by her co-host, Philippe Gaudreau, the CEO of Solabs.
In this week’s episode, they discuss investigation deviations and non-conformances. Lisa provides many excellent tips to keep in mind as you become familiar with the investigation and deviation management process. These tips will surely help listeners enhance their quality programs! This is a wealth of information for those new to the industry and veterans alike!
This episode officially wraps up the six-part series with Lisa Helmonds! Be sure to subscribe to the podcast for more great episodes on quality management.
Key Takeaways:
[:22] About today’s episode.
[1:22] Lisa Helmonds introduces herself and provides some background on her career.
[2:40] About today’s topic: investigation deviations and non-conformances.
[3:21] Why are investigations of deviations and non-conformances so important in the industry?
[4:52] Are these investigations required by regulatory agencies or voluntary?
[5:57] Is there a difference between a deviation and a non-conformance?
[9:50] What is a root cause analysis?
[10:12] Tools that can be used in the investigation and the root cause analysis process.
[12:23] What do you do after the root cause is identified?
[18:17] What a full investigation report entails.
[22:46] What constitutes a well-written investigation report.
[27:00] From an audit perspective, what do investigators looks for during inspection regarding deviations?
[29:08] Mandy recommends further listening.
[30:17] Mandy thanks Lisa for joining her for this six-part series.
[31:41] Mandy recaps what the six-part series covered.
[33:08] About next week’s episode.
[33:14] If you have any questions, requests, or suggestions, you can contact Mandy Gervasio at [email protected]. If you have any questions for Lisa Helmonds, you can contact her on LinkedIn.
Mentioned in this Episode:
Determine the Root Cause: The Five Whys
Fishbone Diagram for Root Cause Analysis
Failure Mode and Effects Analysis (FMEA)
Part 5: “Management Review and Quality Metrics with Lisa Helmonds from MWA Consulting”
Part 4: “Quality Culture with Lisa Helmonds from MWA Consulting”
Part 3: “Quality Agreements with Lisa Helmonds from MWA Consulting”
Part 2: “Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA Consulting”
Part 1: “Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA Consulting”
Episode 54: Risk Management Tools and Techniques with Michael Tyo
Automating Quality
02/06/24 • 15 min
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 [email protected]
Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo
Automating Quality
01/09/24 • 18 min
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 [email protected]
Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia
Automating Quality
04/04/23 • 19 min
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!
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]
02/04/20 • 37 min
Welcome to the 33rd 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!
Today, Mandy is joined by her co-host, the CEO and founder of SOLABS, Philippe Gaudreau, to bring you a bit of a different episode than usual! They’re going to be walking listeners through a case study that is incredibly relevant to their friends and partners in life sciences in terms of system ownership. These are the things that you may encounter and should consider as part of a case study related to implementing a new EQMS system from the system owner’s lens within the quality function.
Philippe will be playing the role of Mandy’s guest expert as well as the QA Director who will be owning this initiative in the case study. Together, Mandy and Philippe will be walking listeners through what they feel are some of the most important things that you’ll face if you have not yet engaged in this type of initiative.
Key Takeaways:
[:33] Mandy Gervasio welcomes Philippe Gaudreau to the podcast and introduces today’s subject: a case study for implementing a new EQMS from the system owner’s perspective.
[2:55] Mandy explains the roles that she and Philippe will be taking for the case study.
[3:29] Mandy explains the case study format/situation they will be exploring in today’s episode.
[6:06] Philippe starts by providing his first (of three) recommendations for beginning the implementation process.
[7:00] Philippe highlights the areas and roles where you need different people in this process.
[9:18] Philippe stresses the importance of having a steering committee involved.
[10:07] Philippe continues explaining other important and key roles in this process.
[12:36] Mandy highlights some other fantastic episodes related to today’s subject for listeners who want to dive deeper and learn more.
[14:07] Philippe provides his second recommendation for the implementation process.
[17:35] Philippe gives his final recommendation.
[19:19] Mandy and Philippe both stress the importance of having a migration plan for data management.
[23:26] Mandy poses a scenario to Philippe about integrating a new EQMS into their current ERP system. Philippe speaks about what some of the project risks could be, what to consider, and the general timeline.
[26:54] Philippe recommends some best practices for organizations to adopt as part of this rollout.
[32:00] Mandy gives some advice and further recommendations on episodes to check out after listening to today’s!
[33:20] Mandy explains the importance of planning for failure as well as success.
[34:52] Mandy thanks Philippe for providing his expert advice on this week’s podcast.
[35:05] Philippe introduces the new Automating Quality LinkedIn community group.
[36:10] Mandy thanks listeners for tuning in!
Mentioned in this Episode:
Automating Quality Ep. 32: “Major Trends in Automation for the Life Sciences Industry in 2020”
Automating Quality Ep. 29: “Data Migration and Data Integrity with Philippe Gaudreau”
Automating Quality Ep. 12: “Validating a Cloud-Based Solution with Philippe Gaudreau”
Automating Quality Ep. 1: “Change Management with Rachel Fountain”
Automating Quality Ep. 5: “The Do’s and Don’ts of Change Management with Rachel Fountain”
Automating Quality Ep. 14: “Key Elements of Virtual Life Sciences Companies with Lisa Helmonds” (Lisa Helmonds is also featured in episodes: 15, 17, 18,
01/21/20 • 26 min
Welcome to the 32nd 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!
Today’s episode is kicking off season 3! Mandy is joined by her co-host, the CEO and founder of SOLABS, Philippe Gaudreau. Together, they will be discussing some of the major trends in automation for the life sciences industry in 2020.
If you want to know about the upcoming hot topics and trends to be aware of and prepare for in order to stay current and competitive in this ever-changing business landscape, be sure to tune in! These hot trends will be sure to add value to your current and future roles in the space of life sciences.
Key Takeaways:
[:25] About today’s episode!
[1:13] Mandy thanks listeners for tuning in through seasons 1 and 2.
[1:49] Philippe joins in to thank listeners as well, and speaks a bit about what to expect for today’s episode.
[3:13] Hot topic areas that are increasing visibility and growth for the life sciences.
[6:28] Mandy elaborates on the notion of data analytics.
[7:33] Philippe shares his perspective on big data and data analytics and where it’s headed in terms of driving changes within life sciences.
[11:41] The way technology is shifting in life sciences.
[13:16] Progress in mobile med device apps and wearable tech.
[14:50] Philippe’s thoughts on mobile med device apps and wearable tech.
[17:54] What blockchain technology is and how it is entering the life sciences.
[19:29] An upcoming hot trend (to be discussed in a future episode): serialization.
[20:11] Wrapping up the show, Philippe gives some thoughts on another hot trend: single sign-on solutions.
[24:35] Mandy wraps up the show and thanks listeners for tuning in as always!
Mentioned in this Episode:
Automating Quality Ep. 21: “Michael de la Torre on GMP Inspection Analytics”
Automating Quality Ep. 29: “Data Migration and Data Integrity with Philippe Gaudreau”
12/10/19 • 27 min
Welcome to the 31st 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! And today, she is joined by her co-host, Philippe Gaudreau, the founder and CEO of SOLABS.
Today’s show is dedicated to all the SOLABIAN friends who have tuned in for each episode and have supported Automating Quality’s journey for the past two seasons! Mandy and Philippe have been on this thought leadership mission for one and a half years now, partnering with life sciences subject matter experts to bring relevant industry trends and best practices to the forefront.
In this episode, they will be taking a look back at the last two seasons, highlighting some of the best clips from previous episodes. Mandy and Philippe have covered so many topics over the past two seasons — from automated system best practices such as validating your cloud solutions and maintaining data integrity, to various best practices areas like inspection readiness and global inspection trends; as well as current hot topics. For new listeners, this could be a great episode to tune into to find out which episodes you want to go back and listen to next!
So sit back, relax, and enjoy this episode dedicated to all of you — Automating Quality’s listeners!
Key Takeaways:
[:32] Mandy opens up today’s episode by thanking guests and listeners for tuning in for the past two seasons!
[1:54] Philippe thanks Mandy, the guests, and listeners of Automating Quality, and reminisces on their podcast journey.
[3:23] About today’s special ‘best of’ episode!
[4:42] In this first clip, Rachel Fountain speaks about implementing a change management process from episode 1.
[5:29] Jay Turner speaks about optimizing compliance from episode 2.
[5:55] In this episode 3 clip, Mary Senica speaks about evaluating and implementing a software solution.
[6:38] Alan Greathouse speaks about measuring operational effectiveness from this episode 4 clip.
[7:00] Rachel Fountain highlights some do’s and don’ts of change management from episode 5.
[7:36] Rich Greer gives his thoughts on data integrity from this episode 6 clip.
[8:21] In this episode 7 clip, Dr. Richard Prince explains the term ‘local-global’ and why it is so useful to remember.
[9:14] Nathalie Bourgouin explains the main difference between a GMP quality system versus a GCP quality system from episode 8.
[9:47] Graham O’Keefe gives his thoughts on effective training methods for millennials from episode 9.
[10:26] Jay Turner speaks about social and collaborative learning from this episode 11 clip.
[10:57] In this episode 12 clip, Brian McNamara speaks about building an effective training assessment program.
[11:25] Philippe Gaudreau speaks about validating a cloud-based solution from episode 12.
[12:20] In the first episode of the 6-part series (ep. 14), Lisa Helmonds gives her thoughts on some of the key elements of virtual life sciences company.
[13:02] In episode 2/6 of the series (ep. 15) with Lisa, she speaks about some of the qualifications and oversight of contract service providers.
[13:51] In episode 3/6 (ep. 17) of the series with Lisa, she speaks about quality agreements.
[14:55] In episode 4/6 (ep. 18) of the series with Lisa, she gives her thoughts on quality culture.
[15:37] In episode 5/6 (ep. 19) of the series with Lisa, she speaks about management review and quality metrics.
[16:26] In the last episode of the series with Lisa (ep. 20), she speaks about investigation deviations and non-conformances.
[17:01] In this episode 21 clip, Michael de la Torre speaks about GMP inspection analytics.
[17:47] Justin Lacombe gives his thoughts on quality by design from episode 22.
[18:50] Jay Turner speaks about what makes a good facilitator from episode 23.
[19:28] Phil Becker speaks about leveraging a risk-based approach to develop, implement, and maintain your IT program from episode 25.
[20:38] In this episode 27 clip, Kathy Landes speaks about the LIR process.
[21:15] Mandy speaks about data migration from this episode 29 clip.
[22:07] Nathalie Bourgouin speaks about inspection readiness from a GCP and GMP lens.
[22:34] Mandy thanks listeners for tuning in to today’s episode and shares when Automating Quality will be returning for season 3!
Mentioned in this Episode:
Episode 38: Data Integrity and Data Governance in a Remote Work Environment with Ben Locwin
Automating Quality
06/09/20 • 36 min
Welcome to the 38th 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! Today’s episode is a little different than usual. Philippe Gaudreau will be joining Mandy as a co-host in a conversation with guest expert Ben Locwin. Ben is the SVP of Quality at Lumicell and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.
This week, they are discussing Data Integrity and Data Governance in today’s landscape. Ben explains the difference between data integrity and data governance, discusses the challenges of remote work during COVID-19 from a GxP perspective and breaks down some tips for companies to incorporate work from home in their company culture in a safe and efficient way!
Key Takeaways
0 :33 : Mandy introduces today’s co-host Philippe Gaudreau.
1:22 : Mandy introduces today’s guest, Ben Locwin.
2:15: Today’s topic is Data Integrity and Data Governance in today’s remote work culture.
3:02: Ben provides an overview of his background in Life Sciences.
9:15: Ben explains the difference between data integrity and data governance.
9:50: The guests discuss the unique challenges for handling work from home and COVID-19 from a GxP Data Integrity perspective?
11:57: Philippe details some of the dangers for data integrity with employees working from home and shares his opinion on the future of online security.
14:31: Ben stresses the importance of the Quality / Regulatory and IT / Security team members work hand in hand to ensure the integrity of data.
17:15: Ben discusses the delicate balance between ease of use and standardization of inputs and outputs within software.
20:14: The group discusses tips and tricks for remote workers to improve their efficiency.
23:39: Ben insists on the importance of having a routine on the human psyche.
26:10: Mandy insists on the importance of recording important meetings to keep track of information
27:28: Philippe gives some tips for companies to incorporate work from home in their company culture in the long term.
30:27: Mandy suggests reviewing data governance policies and ensuring that the team is comfortable with working from home.
31:55: Ben stresses the importance of having clear data governance policies in the future.
33:53: Mandy thanks Ben and Philippe and reflects on today’s learnings.
Mentioned in this episode Ben Locwin on LinkedIn [email protected]
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FAQ
How many episodes does Automating Quality have?
Automating Quality currently has 59 episodes available.
What topics does Automating Quality cover?
The podcast is about Life Sciences, Podcasts, Science, Business and Careers.
What is the most popular episode on Automating Quality?
The episode title 'Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam' is the most popular.
What is the average episode length on Automating Quality?
The average episode length on Automating Quality is 24 minutes.
How often are episodes of Automating Quality released?
Episodes of Automating Quality are typically released every 21 days.
When was the first episode of Automating Quality?
The first episode of Automating Quality was released on Jun 25, 2018.
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