Shows
SOLABS QM InsightsEpisode 64: SOLABS' Roadmap with Philippe GaudreauIn this episode of the QM Insights podcast, Etienne and Philippe discuss the latest updates to QM10 and what's in the pipeline for the upcoming months! View SOLABS' full roadmap here: Roadmap for SOLABS QM10, QM APPs and Services – SOLABS Knowledge Base Key takeaways: 00:20 SOLABS news 03:20 Introducing some new features recently made available to clients 07:15 Our work on the reporting portal 11:00 We're revamping QM10's UI! 14:20 A variation of the deviation QM APP is in the works for smaller companies 2024-11-2617 min
Automating QualityEpisode 60: Investigative Methods with Michael TyoWelcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management. In today’s episode, Michael and Philippe discuss investigation methods, how to apply them in detail, and the various tools available for conducting investigations. Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting. Key Takeaway 01:24 Introducing today’s guest: Michael Tyo 01:55 Today’s topic is investigative methods and what happens when things go wrong 03:36...2024-11-0518 minAutomating QualityEpisode 59: Introduction to Investigations with Michael TyoAutomating Quality Episode 59 – Inspection Readiness with Michael Tyo Welcome to Automating Quality, the Life sciences-centric show that bridges the gap between automation and quality. In today’s episode, we discuss inspection readiness, from why we are doing them to how to conduct investigations properly. Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting. Key Takeaways 00:42 Introducing today’s guest: Michael Tyo 01:42 Today’s subject is the investigations, from why they ex...2024-10-0118 minAutomating QualityEpisode 58: Discovering AIBOM and the Future of SBOM with Joseph SilviaWelcome 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 two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. In this episode, we discuss the definition of AIBOM, how it differs from SBOM, and take an educated guess at their future. 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...2024-08-0615 minAutomating QualityEpisode 57: Introduction to the Software Bill of Materials with Joseph SilviaWelcome 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 l...2024-07-0916 minAutomating QualityEpisode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-AdamWelcome 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 featuring guest Caroline Guay-Adam! In this episode, we dive into tips and tricks for maintaining Inspection Readiness including first time right, the importance of the Inspection Manual, and more! 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 a...2024-06-0418 minAutomating QualityEpisode 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 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...2024-02-0615 minSOLABS QM InsightsEpisode 62: Looking Back at 2023 with SOLABS' ExecutivesSOLABS' executives join together to discuss their outlook for 2023. They walk listeners through their objectives at the start of the year and more. Key Takeaways 00:51 Kevin explains what his focus was at the beginning of 2023 for the engineering department. 01:44 How many phases will be necessary for the implementation process of Kamban at SOLABS? 03:38 Ericka explains why the Client Success department’s main area of focus in 2023 was customer satisfaction. 04:58 The return of the User Group Meeting was a great success! 06:19 Martine, head of Product Quality Man...2024-01-1914 minAutomating QualityEpisode 53: Leveraging the FDA's Warning Letters with Michael TyoWelcome 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 conduct...2024-01-0918 minAutomating QualityEpisode 52: Supplier Quality Management w. Mandy GervasioWelcome 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 wor...2023-11-2817 minAutomating QualityEpisode 51: Takeaways from 2023 Quality Conferences with Mandy GervasioWelcome 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...2023-10-1720 minSOLABS QM InsightsEpisode 59: The Implementation of QM10 with Ericka MooreIn this episode of the QM Insights podcast, Etienne is joined by Ericka Moore, Head of Client Success at SOLABS to discuss the implementation process of SOLABS QM10. They discuss whether implementations are done internally or outsourced, what are the key elements that make a successful implementation, and what a successful implementation means for SOLABS. Key Takeaways 00:49 Why do we perform all of our implementations internally? 02:38 Is there an overlapping between implementation and the Client Success roles? 05:41 What is the expected duration of an implementation project at SOLABS and w...2023-08-1514 minAutomating QualityEpisode 50: Analytics for GMP Floor Environment with Jamie VilleneuveWelcome 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...2023-08-0116 minAutomating QualityEpisode 49: Designing Analytics for the Life Sciences Industry with Jamie VilleneuveWelcome 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 a...2023-07-0416 minSOLABS QM InsightsEpisode 58: Analytics at SOLABS with Jamie VilleneuveIn this episode of the QM Insights podcast, Etienne is joined by Jamie Villeneuve to discuss analytics in QM10. Jamie explains Nexgen Analytics' custom report offering, what is the end goal of analytics, and what the future holds for SOLABS in this area. Key Takeaways: 00:55 Introducing Jamie and Nexgen Analytics 02:00 What has NexGen Analytics accomplished for SOLABS’ clients so far? 03:00 What is the custom report offering for our clients? 06:40 What is the end goal for analytics? 10:15 Do analytics have to adapt to a company’s reali...2023-05-1615 minAutomating QualityEpisode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph SilviaWelcome 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 Or...2023-05-0214 minSOLABS QM InsightsEpisode 57: SOLABS - Who We Are and Where do we Come FromIn today’s episode of the QM Insights podcast, Philippe Gaudreau, CEO of SOLABS and Ericka Moore, Head of Client Success at SOLABS discuss the business highlights of SOLABS, what will be our focus moving forward, and what are the values that drive our work! Key Takeaways 02:00 Philippe highlights key achievements we have accomplished 02:58 Ericka shares some of the highlights she is most proud of at SOLABS 06:23 How is Supplier Quality Control going to be a priority for SOLABS moving forward? 11:10 We are working on supporting suppliers on...2023-04-1814 minAutomating QualityEpisode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph SilviaWelcome 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, Direc...2023-04-0419 minSOLABS QM InsightsEpisode 56: What is Coming in 2023 with SOLABS' ExecutivesIn today’s episode of the QM Insights podcast, SOLABS’ executives are discussing their objectives for 2023 and what clients can expect from SOLABS this coming year. Key Takeaways 00:56: introducing Ericka, Head of Client Success at SOLABS 02:17: the SOLABS QM10 User Group Meeting will return in 2023! 04:17: Introducing Martine, Head of Quality Management at SOLABS 05:00: SOLABS is ISO 9001:2015 certified! 06:47 Introducing Kevin, Head of Engineering 08:11 We are working towards automated testing 10:22 Philippe talks about SOLABS’ focus in 2023: client satisfaction! 12:38 We are working on cont...2023-03-0714 minAutomating QualityEpisode 46 - Defining Data Quality with Steve GensWelcome 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 incl...2023-01-1017 minAutomating QualityEpisode 45 - The World Class RIM Benchmark by Gens & Associates Featuring Steve GensWelcome 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 discuss the World Class RIM Benchmark conducted by Gens & Associates, how it came into being, and some of its key findings over time. 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 rese...2022-12-1322 minAutomating QualityEpisode 40: What are Real-World Data and Real-World Evidence? With Ben LocwinWelcome 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 a conversation with guest expert Ben Locwin. Ben is the VP of Project Solutions at Black Diamond Networks 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. The topic of today’s discussion is about defining what are Re...2022-07-1222 minSOLABS QM InsightsEpisode 48: Superseding and Retiring Documents in SOLABS QM10In today’s episode, we discuss the differences between retiring and superseding documents within QM10. Gretchen, a Product Specialist at SOLABS, covers multiple scenarios where our clients make use of either function and provides tips on how to save time with them! Key Takeaways 00 :00 Introducing today’s topic: retiring and superseding documents in QM10 01:17 What are the differences between retiring and superseding 02:22 Do traces of retired documents still exist within the software? 03:40 Can you bring a document back if it ever becomes relevant again? 05:36 How often...2022-04-2111 minSOLABS QM InsightsEpisode 44: Document Management in QM10, Part 3: Document AdministrationThe QM Insights podcast show is back on its mission to help SOLABS’ clients to learn from experience. Today’s episode is Part 3 of our series on how QM10 helps our clients with document management. In this episode, we focus on the tools available to Document Administrators to assist with their document administration needs. 00:41 Introducing today’s guests: Gretchen Dixson and Philippe Gaudreau 01:04 Find previous episodes from this series here: QM Insights Podcast – SOLABS 01:35 Philippe provides a sneak peek of our 10.9 release 04:50 Our support team is currently scheduling...2021-09-2115 minSOLABS QM InsightsEpisode 42: Document Management in QM10, Part 1: Periodic Reviews With the Document Control ProcessThe QM Insights podcast show is back on its mission to help SOLABS’ clients Learn from Experience. In today’s episode, the team discusses how the QM10 Document Control Process can help our clients manage Periodic Review Cycles for their documents that require it. This is part 1 of a series on managing document Periodic Reviews using QM10. Etienne Langlois, Sr. Marketing Coordinator, is today's host. Our guests are Gretchen Dixson, Head Trainer, and Product Specialist at SOLABS, and Philippe Gaudreau, CEO at SOLABS. 00:44 Introducing today's guests, Gretchen Dixson and Philippe Gaudreau ...2021-06-0810 minSOLABS QM InsightsEpisode 41: SOLABS Services, Security and ArchitectureThe QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience. In today’s episode, the team discusses the services offered by SOLABS, how we handle security and our responsibility in regard to data and reporting. Etienne Langlois, SOLABS’ Marketing Coordinator is taking over as today’s host while Ericka is taking a break for health reasons. Our guests today are Kevin Byrne Langlois, Head of Engineering at SOLABS and Philippe Gaudreau, CEO at SOLABS. 00 :32 Introducing Today’s Guests, Kevin Byrne Langlois and Philippe Gaudreau 01:08 Y...2021-05-1817 minSOLABS QM InsightsEpisode 40: SOLABS' New Tagline, Our Q1 Performance and The Importance of System Ownership w. Philippe GaudreauThe QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience. In today’s episode, the team discusses SOLABS’ performance over Q1 2021, how we got to the Learn From Experience tagline and the importance of System Ownership procedures. Etienne Langlois, SOLABS’ Marketing Coordinator is taking over as today’s host while Ericka is taking a break for health reasons. Philippe Gaudreau, SOLABS’ CEO, is our guest today! 0:36 Etienne introduces today’s guest: Philippe Gaudreau 1:14 SOLABS’ performance in Q1 2021 4:13 New resources in SOLABS’ Knowledge Base 5:50 Et...2021-04-2016 minSOLABS QM InsightsEpisode 39: Product Roadmap, New Reporting Capabilities and More With Philippe Gaudreau, Jamie Villeneuve & Gretchen DixsonThe QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience, continuously improve and do more with less. In today's episode, the team discusses our product roadmap for the upcoming months and years, introduces our partners at Nexgen and the exciting reporting capabilities they bring to our clients and more! Today’s guests are Philippe Gaudreau, SOLABS’ CEO, Jamie Villeneuve, Owner of NexGen Analytics and Gretchen Dixson, Product Specialist at SOLABS. 0:40 - Ericka introduces today’s guests: Gretchen, Jamie & Philippe 1:13 - Philippe discusses our approach for QM10’...2021-03-1627 minSOLABS QM InsightsEpisode 38: QMI 38 – SOLABS 2020 in Numbers & Our New Software Support Specialist! With Philippe, Kevin and Mathieu The QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience, continuously improve and do more with less. In this week’s episode, our host Ericka Moore is joined by SOLABS’ CEO Philippe Gaudreau, our Head of Engineering Kevin Byrne Langlois and our new Software Support Specialist Mathieu Carriere! The team discusses how much QM10 was used throughout 2020, the reasoning behind hiring a Software Support Specialist, its expected impact for our clients, how Mathieu’s profile fits such a role and more! Key Takeaways: 0:30 – Ericka announces t...2021-02-0222 minSOLABS QM InsightsEpisode 37: Looking Back at 2020 With SOLABS’ ExecutivesThe QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience, continuously improve and do more with less. This week’s episode is a little different from usual as our host Ericka Moore is joined by SOLABS’ executives to look back at the challenges, realizations and overall performance of each department for 2020. These executives are SOLABS’ CEO Philippe Gaudreau, our Head of Engineering Kevin Byrne Langlois, our Head of Product and Quality Management Martine Boire and finally our Marketing Coordinator Etienne Langlois. Key Takeaways 0:45 – Today’s topic is loo...2020-12-1540 minSOLABS QM InsightsEpisode 36: Best Practices Around Document Control with Philippe, Martine, Gretchen and EtienneThe QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience, continuously improve and do more with less. This week on the show, Ericka Moore returns as your host! She is joined by SOLABS’ CEO Philippe Gaudreau, SOLABS’ Head of Product and Quality Management Martine Boire, SOLABS’ Product Specialist and Head Trainer Gretchen Dixson and finally SOLABS’ Marketing Coordinator Étienne Langlois. In today’s episode, the team discusses best practices around document control, both in and out of QM10. They discuss key points to consider when implementing a document control process, the importanc...2020-11-1024 minSOLABS QM InsightsEpisode 35: Level 1 Service Level Agreement (SLA) with Gretchen and PhilippeThe QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience, continuously improve and do more with less. This week on the show, Ericka Moore returns as your host! She is joined by SOLABS’ CEO Philippe Gaudreau and SOLABS’ Product Specialist and Head Trainer Gretchen Dixson. In today’s episode, the team has a conversation on SOLABS’ new Level 1 Service Level Agreement (SLA). They explain why it was created, the advantages for our clients and how some of them currently use their Level 1 banks of hours. The guests also exchange on the new Wo...2020-10-2023 minSOLABS QM InsightsEpisode 34: Ericka's Return! with Philippe, Martine, Kevin and ErickaThis week on the podcast, Etienne Langlois, SOLABS’ Marketing Coordinator is back as your host! He is joined by Philippe Gaudreau, SOLABS’ CEO, Martine Boire, the team’s Head of Product and Quality Management, Kevin Byrne Langlois, SOLABS’ Head of Engineering and Ericka Moore, SOLABS’ Head of Client Success. Today, the team will discuss frequently asked questions about SOLABS, new resources available for clients on SOLABS’ Knowledge Base and more. They will also chat about Ericka’s return in the SOLABS team after a prolonged leave and how this will impact our clients’ lives! Key Takeaways:2020-10-0622 minSOLABS QM InsightsEpisode 33: The QM Insights Podcast is Back! with Philippe, Martine and GretchenThis week on the podcast, Etienne Langlois, SOLABS’ Marketing Coordinator is your host! He is joined by Philippe Gaudreau, SOLABS’ CEO, Martine Boire, the team’s Head of Product and Quality Management and Gretchen Dixson, SOLABS’ Head Trainer and Product Specialist. Today, they are trying out a new conversational format for the show! The team will discuss frequently asked questions about SOLABS, new resources available for clients on SOLABS’ Knowledge Base and more. Key Takeaways: 0 :45 – Etienne introduces today’s guests: Philippe Gaudreau, Martine Boire and Gretchen Dixson. 1:44 – The new show structure is r...2020-09-2216 min
Automating QualityEpisode 38: Data Integrity and Data Governance in a Remote Work Environment with Ben LocwinWelcome 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 Init...2020-06-0936 minSOLABS QM InsightsEpisode 32: SOLABS Laboratory Investigation Request Process (LIR QM APP) with Gretchen DixsonThis week on the podcast, Philippe Gaudreau, the CEO and founder of SOLABS, is once again joined by frequent guest, Gretchen Dixson, the Senior Product Specialist and Head Trainer at SOLABS! Today, they will be discussing SOLABS’ laboratory investigation request process (or LIR process). Gretchen explains how the LIR process ensures the documentation of everything within the laboratory investigation, the differences between the deviation process (in terms of capturing lab investigations) vs. the LIR process, and gives a detailed step-by-step of everything that is involved in the LIR process. Key Takeaways: 2020-03-2417 minSOLABS QM InsightsEpisode 31: Deviations Process App with Gretchen DixsonIn today’s episode, your host Philippe Gaudreau, the CEO and founder of SOLABS, is joined by a frequent guest of the show — Gretchen Dixson, the Senior Product Specialist and Head Trainer at SOLABS! Today, they will be taking a look the Deviations Process App (P0054) used for deviations in the context of the GxP pharmaceutical environments. Gretchen covers the main steps within the deviation process and what they’re being used for, the items that are linked to deviation, which reports are available for this process, whether or not deviations can be used for lab inve...2020-03-1013 minAutomating QualityEpisode 35: Clinical Inspection Readiness: the Initial Stage with Nathalie Bourgouin — Part 1Welcome to the 35th 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 show is pretty exciting! Mandy is going to be revisiting a topic that Automating Quality covered a bit last season around the GCP space. Joining her to discuss this topic is a veteran guest of the show who previously introduced the GCP topic — Nathalie Bourgouin! Nathalie is the Vice President of Compliance at Skillpad, which is a sister company of SOLABS...2020-03-0320 minSOLABS QM InsightsEpisode 30: Presenting SOLABS’ New Website and Knowledge BaseOn this episode of SOLABS QM Insights, Philippe Gaudreau is joined by his special guest, Étienne Langlois. Étienne is the Senior Marketing Coordinator at SOLABS and has been working hard on the new SOLABS website and knowledge base live available to all their clients! Since the new website just went live (as of the day of recording), Philippe and Étienne wanted to share some of the key aspects of it with you all today! Étienne takes listeners through an audio tour of all of the new changes from how the new design was made especially with...2020-02-2513 minAutomating QualityEpisode 34: Artificial Intelligence from a Life Sciences’ PerspectiveWelcome to the 34th 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! In this week’s episode, Mandy Gervasio is bringing you a fascinating and timely topic to discuss: Artificial Intelligence or AI. This technical niche and hot industry trend of adoption is quite fascinating and you’ve probably been hearing this term a lot — especially in the last year or two! She’s going to discuss the impact of AI on the li...2020-02-1823 minSOLABS QM InsightsEpisode 29: An Overview of the Audit QM APP with Gretchen DixsonThis week on the podcast, Philippe Gaudreau, CEO and founder of SOLABS, is joined by return guest Gretchen Dixson, the Senior Product Specialist and Head Trainer at SOLABS. Today, Philippe and Gretchen will be discussing Audit Management, one of SOLABS’ QM APPS. Gretchen explains the steps of the audit process and the purpose of each of those steps provides some examples of how SOLABS’ clients use this process, details available add-ons available for the app, and explains where a user can find documentation and information regarding the Audit QM APP if they would like to learn more! 2020-02-1112 minAutomating QualityEpisode 33: Case Study for Implementing an EQMS from a System Owner’s LensWelcome 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 cons...2020-02-0437 minSOLABS QM InsightsEpisode 28: SOLABS Product Roadmap Survey ResultsThis year is going to be a very important year for SOLABS as they are rolling out 10.8 in 2020. SOLABS sent out their Product Roadmap Surveys to clients in the months of November and December 2019, and more than 90% of clients provided responses to the survey! So in today’s episode, Philippe Gaudreau, the founder and CEO of SOLABS, will be going over some of the key results of these surveys and sharing some of the invaluable responses that will be indispensable in helping SOLABS’ product roadmap for 2020. A detailed write-up of the results will later be sent...2020-01-2814 minAutomating QualityEpisode 32: Major Trends in Automation for the Life Sciences Industry in 2020Welcome 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 orde...2020-01-2126 minAutomating QualityEpisode 31: Guest Tribute Show: ‘Best of’ Moments from the Last Two Seasons!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, partner...2019-12-1027 minSOLABS QM InsightsEpisode 27; An Overview of the CAPA QM App (P50) with Gretchen DixsonThis episode marks the final episode of the year for 2019! This episode will be dedicated to SOLABS’ EQMS, SOLABS QM 10 — specifically focusing on one of the off-the-shelf QM Apps known as P50 that is a CAPA process. And once again, Gretchen Dixson will be joining the podcast! Gretchen is the Senior Product Specialist and Head Trainer at SOLABS and she has been quite involved with clients who are working with the CAPA QM App (P50) by training them on it and helping them figure out how they’re going to use it. Today, Gretchen and Philipp...2019-12-0322 minAutomating QualityEpisode 30: Inspection Readiness from a GCP and GMP Lens with Nathalie BourgouinWelcome 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 wel...2019-11-2629 minSOLABS QM InsightsEpisode 26: The Buyer’s Journey: Key Considerations When Preparing to Make an EQMS Software PurchaseThis week on the podcast, Philippe Gaudreau, CEO and founder of SOLABS is joined by Tom Ince, SOLABS’ Enterprise Sales Specialist. Today, they will be taking a look at the buyer’s journey when it comes to making an EQMS software purchase. In this episode, Tom explains how an organization can prepare for an EQMS software purchase, how you can go about establishing a budget for such a project, how to go about comparing and evaluating different solutions and vendors, and much more. Tom provides tons of key guidance on how exactly you should be condu...2019-11-1913 minAutomating QualityEpisode 29: Data Migration and Data Integrity with Philippe GaudreauWelcome to the 29th 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 is a really fun episode! Mandy is joined by her co-host, founder and CEO of SOLABS, Philippe Gaudreau. And they’re partnering together in this episode to discuss data migration as it relates to data integrity. This topic has risen to the top in relevancy in the GMP world, so today, Mandy and Philippe will be highlighting some of...2019-11-1233 minSOLABS QM InsightsEpisode 24: SOLABS QM Features You May Not Know About! With Martine BoireThis week on the podcast, Philippe Gaudreau, CEO and founder of SOLABS, is joined by return guest, Martine Boire! Martine is the Head of Product and Quality Management at SOLABS. Previously, she served as Director of Quality for over 12 years. Today, Martine is highlighting some of the features that end-users might not be aware of that would really benefit and ease their use of SOLABS QM! These functions are not necessarily hidden, but they’re also not so intuitive as to immediately be seen on the user interface. This episode will be t...2019-11-0516 minSOLABS QM InsightsEpisode 24: Best Practices in Configurations of the Training Section with Gretchen DixsonThis week Philippe Gaudreau, CEO and founder of SOLABS, is joined by return guest Gretchen Dixson, the Senior Product Specialist and Head Trainer at SOLABS. Today, they’re discussing the training section and some of the most common use cases she has encountered while working with clients in terms of configuring and helping improving practices in that area. Training is a key subject as most users of SOLABS QM will have to log into it once in a while in order to record training. Philippe recommends you check episode 2 of SOLABS QM Insights as well to...2019-10-2219 minAutomating QualityEpisode 28: Regulatory Convergence and Its Impact on the Life Sciences IndustryWelcome to the 28th 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 regulatory convergence! In the world of globalization, it makes sense that we’re finally starting to see extensive shifts in philosophy and regulations as they apply to the Life Sciences industry, which are setting new quality standards for drug and device manufacturers. It’s a very exciting topic as there have been some incredibly notable changes in the las...2019-10-1613 minSOLABS QM InsightsEpisode 23: Service Level Agreement with Karine LoiselleThis week Philippe Gaudreau, the CEO and founder of SOLABS, is joined by Karine Loiselle, a member of SOLABS’ Client Success Group. Karine is a Client Success Specialist and has been with SOLABS for 2 years now. Karine spends a good portion of her time in direct contact with SOLABS’ clients and she coordinates all of the work behind the scenes of their support. In this episode, Philippe and Karine will discuss service level agreement. Karine provides an excellent overview of their service level agreement at SOLABS; diving into how the support team handles clients’ concerns and how...2019-10-0913 minAutomating QualityEpisode 27: The LIR Process and Key Considerations for Robustness with Kathryn LandesWelcome to the 27th 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 on the podcast, Mandy is bringing you a topic that has yet to be discussed in-depth on the show, and that is Laboratory Investigation Reports (also known as LIRs) and critical elements to consider when designing or implementing enhancements to the quality management process. Ensuring that your LIR process is robust is critical to your business operation and will help set you...2019-10-0226 minSOLABS QM InsightsEpisode 22: Training Plan with Gretchen DixsonThis week Philippe Gaudreau, the CEO and founder of Solabs, is joined by return guest Gretchen Dixson, the Senior Product Specialist at Solabs. On today’s show, they will be discussing the training plan and approach during the implementation stage of Solabs QM 10, from the pre-training preparation to the post-training follow-up. Gretchen provides some incredibly valuable insight on topics such as: ways to prepare for a training session, what the training plan looks like during implementation, and how she has seen training evolve in enterprise software over the years. This episode will help you with your...2019-09-2520 minAutomating QualityEpisode 26: Current Hot Trends in the Medical Device IndustryWelcome to the 26th 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 show is focusing on a topic that has yet to be discussed on the show thus far, and that is the medical device industry and current hot trends from a regulatory perspective! Automating Quality has taken a look at regulatory trends from a broader perspective, but this is the first time they will be diving deep into the current happenings in the...2019-09-0416 minAutomating QualityEpisode 25: How to Leverage a Risk-Based Approach to Develop, Implement, and Maintain Your IT Programs, with Phil BeckerWelcome to the 25th 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 leveraging a risk-based approach to develop, implement, and maintain your IT programs, extending to GxP controls and critical infrastructure. Guest industry expert, Phil Becker, will be joining Mandy today to discuss this topic and to provide guidance! Phil has over 30 years of experience in the IT field. He’s an industry thought leader w...2019-08-0631 minSOLABS QM InsightsEpisode 20: Product Road Map with Gretchen Dixson and Martine BoireThis week, Philippe Gaudreau, the CEO and founder of Solabs, is joined by Gretchen Dixson (Senior Product Specialist at Solabs) and Martine Boire (Head of Product and Quality Management). They will be discussing the product road map — covering potential new releases, upcoming changes, and enhancements within the Solabs QM 10 solution. Some of the items they will be taking a look at include: UI enhancements, the user experience in the doc control process, the training section, tree view, training activities and materials, training profiles, reporting, and permissions. Tune in to hear all about Solabs’ roadmap for the n...2019-07-1638 minAutomating QualityEpisode 24: All About the Quality Risk Management LifecycleWelcome to the 24th 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 focusing on quality risk management — the process for systematically identifying, assessing, and controlling risk to the quality of pharmaceutical products across the product lifecycle. Although the Automating Quality Podcast talks about risk quite often, this episode will be specifically zoning in on the concept of quality risk management (or QRM), how it is implemented, the four key phases that de...2019-07-0923 minSOLABS QM InsightsEpisode 19: Talking the Upcoming QM 10.8 Release with Gretchen DixsonThis week, Philippe Gaudreau, the CEO and founder of Solabs, will be talking more about the upcoming June 2019 QM 10.8 release with Gretchen Dixson, a Senior Product Specialist at Solabs. Gretchen has been with the company for a little over 2 years now and currently serves as Head Trainer. She is also actively involved in the sales and marketing team and has built the user guide for the Questionmark interface. Prior to joining Solabs, Gretchen spent over 35 years in the QA Life Sciences industry. In this episode, Philippe and Gretchen will be focusing on some of the s...2019-07-0213 minAutomating QualityEpisode 23: Innovation to Retrovation: Maintaining GTP in a GxP World, with Jay TurnerWelcome to the 23rd 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, Philippe Gaudreau, and return guest from episodes two and ten, Jay Turner! Jay is the CEO and founder of EduJay LLC., and he is a self-proclaimed learning and development ninja! He has devoted his career to improving people, processes, and programs to produce business results. This includes everything from implementing learning management systems, to designing sta...2019-06-2532 minAutomating QualityEpisode 22: Justin Lacombe on Quality by DesignWelcome to the 22nd 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 joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Justin Lacombe. Justin has a depth of experience in pharmaceutical development and implementing methodologies founded in Quality by Design (QbD). He is a Chemical Engineer and got his PhD in Chemical Engineering from Rutgers University. He has been spending the past 12 years in the...2019-06-1126 minAutomating QualityEpisode 21: Michael de la Torre on GMP Inspection AnalyticsWelcome to the 21st 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 joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Michael de la Torre. Michael is Chief Executive Officer of Govzilla — the leading platform for GxP inspection analytics. As a company, they are leveraging the power of Big Data and Machine Learning to make government data accessible, usable, and valuable to everyone who needs...2019-05-2126 minSOLABS QM InsightsEpisode 17: The Responsibilities of System Owners in SOLABS QM 10This week, Philippe Gaudreau, the CEO and founder of Solabs, will be your solo host! Today he will be discussing the responsibilities of system owners — a topic he is very passionate about! He feels that with the appropriate controls in place, system owners will be able to ensure that their Solabs QM 10 solution remains in good health throughout its life cycle in their organization. Today, he reviews five major items he feels should be included in a system ownership procedure for the administration, support and maintenance of QM 10, including: 1- administration and control procedures, 2- sys...2019-05-1419 minAutomating QualityEpisode 20: Investigation Deviations and Non-Conformances with Lisa Helmonds Vice President from MWA ConsultingWelcome 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 t...2019-05-0733 minSOLABS QM InsightsEpisode 16: Document Tree View from an Initial Configuration Standpoint with Gretchen DixsonThis week on the podcast, Philippe Gaudreau, the CEO and founder of Solabs, is joined by their return guest, Gretchen Dixson, to discuss the document tree view on Solabs QM from an initial configuration standpoint. Gretchen is a Senior Product Specialist at Solabs and a part of Ericka’s group, the Client Success Group. She has been with the company for a little over 2 years now and serves as Head Trainer. She’s also actively involved in the sales and marketing team and has built the user guide for the Questionmark interface! Prior to joining Solabs, Gretchen spen...2019-04-3014 minAutomating QualityEpisode 19: Management Review and Quality Metrics with Lisa Helmonds from MWA ConsultingWelcome to the 19th 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 bringing you the fifth part of the six-part series focused around quality culture, the virtual pharma environment, and supply chain management. As always, she is joined by her veteran guest of the series, Lisa Helmonds! 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...2019-04-2324 minAutomating QualityEpisode 18: Quality Culture with Lisa Helmonds from MWA ConsultingWelcome to the 18th 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! Mandy is excited to bring you the fourth part in the six-part series with Lisa Helmonds about virtual companies in the life sciences space! As a reminder, 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...2019-03-2621 minAutomating QualityEpisode 17: Quality Agreements with Lisa Helmonds from MWA ConsultingWelcome to the 17th 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 will be the third part in the six-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 lar...2019-03-1227 minAutomating QualityEpisode 16: Continuous Improvement of Quality Management SystemsWelcome to the 16th 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! In this week’s episode, Mandy dives deep into the topic of continuous improvement of quality management systems. She discusses what is meant by continuous quality improvement, the expectations from a regulatory perspective, key systems that are leveraged to provide visibility and enhance quality throughout an organization, why quality management review is important in terms of your quality infrastructure, and types of exter...2019-02-2612 minSOLABS QM InsightsEpisode 15: Gretchen Dixson on SOLABS QM Configurations and Best PracticesIn today’s show, your host, Ericka Moore, and her return guest, Gretchen Dixson, will be discussing the Solabs QM configuration, best practices, and how the Solabs team supports configuration activities with clients. Gretchen is a Senior Product Specialist at Solabs and a part of Ericka’s group, the Client Success Group. She has been with the company for a little over 2 years now and serves as Head Trainer. She’s also actively involved in the sales and marketing team and has built the user guide for the Questionmark interface! Prior to joining Solabs, Gretchen spent o...2019-02-1923 minAutomating QualityEpisode 15: Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA consultingWelcome 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...2019-02-1222 minSOLABS QM InsightsEpisode 14: Philippe Gaudreau on the Pricing Model and Client Services Offering in Solabs QMWelcome to the first episode back in 2019! In this episode, Philippe Gaudreau, the CEO and founder of Solabs, will be Ericka’s guest as well as her co-host as they discuss the pricing model and client services offering in Solabs QM. Often, companies speak a lot about what they offer in terms of products and services but pricing can often be a bit of a taboo topic. Solabs has developed a great pricing model that’s very interesting to discuss, so in this episode, Ericka and Philippe will be discussing the different components of the Solab...2019-02-0522 minAutomating QualityEpisode 14: Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA consultingWelcome to the first episode back in the new year! Your host, Mandy Gervasio, and her co-host, Philippe Gaudreau, the CEO of Solabs, are back to start a very interesting new series. Continuing their mission to bring more clarity around the world of quality and automation in the area of life sciences, they’ve invited on a life sciences expert, Lisa Helmonds. 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...2019-01-2926 minSOLABS QM InsightsEpisode 13: An Overview of QM APPS with Ericka MooreYour host Ericka Moore, Head of Client Success at Solabs, will be leading today’s episode! In celebration of this episode being the final podcast of the year, she will be talking about QM APPS — a product she has done a lot of work on herself, and is extremely passionate about. The QM APPS are different quality processes that are used within the life sciences industry, that can be deployed within the core system in the process section at any given time, within Solabs QM 10. In this episode, she will be giving...2018-12-1822 minAutomating QualityEpisode 13: Recapping Industry Trends in 2018Welcome to the 13th episode of Automating Quality, the show that bridges the gap between automation and your quality management systems. 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! Being the last episode of the year, Mandy is bringing you a recap of the greatest industry trends in 2018 and taking a look back at the last 12 episodes of Automating Quality. She’s reviewing some of the key highlights, including: change management, operational effectiveness, phase appropriate quality, philosophies of qualit...2018-12-1114 minSOLABS QM InsightsEpisode 12: Questionmark OnDemand Interface in SOLABS QM 10 with Gretchen DixsonToday’s episode is about an exciting new feature that was recently added to Solabs QM 10: the Questionmark OnDemand interface within Solabs QM. In this episode, your host, Ericka Moore, is joined by return guest, Gretchen Dixson. Gretchen is a Senior Product Specialist at Solabs and a part of Ericka’s group, the Client Success Group. She has been with the company for a little over 2 years now. She serves as Head Trainer, with her duties including: building training material and delivering training sessions for upcoming and current clients. She’s also actively involved in the sal...2018-12-0420 minAutomating QualityEpisode 12: Validating a Cloud-based Solution with Philippe GaudreauWelcome to the twelfth episode of Automating Quality, the show that bridges the gap between automation and your quality management systems. 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 show is focusing on validating a Cloud-based solution. And the featured guest expert is none other than Mandy’s co-host, Philippe Gaudreau, the CEO of Solabs. Philippe has been in the technology industry for the past 20 years mostly within life sciences. He also has developed important competencies in compu...2018-11-2724 minSOLABS QM InsightsEpisode 11: Solabs QM SSRS Reports for TrainingToday’s episode is a bit of a special one! Typically, a guest expert from Solabs is featured — but on this episode, Ericka and Philippe will take you through today’s topic: SSRS reports for training. With Solabs QM 10, clients have access to a sharepoint portal which contains two different types of reports: excel reports and SSRS reports. Today, Ericka will be focusing on the SSRS reports for training, featuring: the training compliance distribution report, employee training compliance report, training compliance by department report, employee training compliance history report, and more! This episode will bring to lig...2018-11-2033 minAutomating QualityEpisode 11: How to Build an Effective Training Assessment Program with Brian McNamaraWelcome to the eleventh 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! Mandy is joined by her co-host, Philippe Gaudreau, and very special guest: Brian McNamara, the Marketing Director for Questionmark. Today’s topic of discussion is building an effective training assessment program. Brian has a ton of experience in this niche and has some very good expert feedback on the topic. He really knows his stuff when it comes to electronic assessment and certi...2018-11-1330 minSOLABS QM InsightsEpisode 10: CEO Philippe Gaudreau on the Upcoming Solabs QM 10 ReleaseIn today’s show, your host — and the founder and CEO of Solabs — Philippe Gaudreau, speaks about the November 2018 release of Solabs QM 10. He reviews the changes from both the core software and the document control process. As of this release, Solabs is moving to a one-release-every-4-months schedule. The November release is the first of this series with the next release being in February, 2019. In this episode, Philippe highlights the changes in this release that have an impact on end users — such as functions that have been added and changes to the user interface. Major improvements have bee...2018-11-0617 minAutomating QualityEpisode 10: Social and Collaborative Learning with Jay TurnerWelcome to the tenth 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, Philippe Gaudreau, and return guest from episode two, Jay Turner! Jay is the CEO and founder of EduJay LLC. Jay is a self-proclaimed learning and development ninja at his latest entrepreneurial venture, EduJay! He has devoted his career to improving people, processes, and programs to produce business results — everything from implementing learning management systems, to desig...2018-10-2943 minSOLABS QM InsightsEpisode 9: Tips, Tricks, and Tools of the SOLABS QM User Interface with Gretchen DixonIn today’s show, the founder and CEO of Solabs, Philippe Gaudreau, presents different tips and tricks of the Solabs QM User Interface and cover the different sections of the application. He’s joined by return guest, Gretchen Dixson, Solabs Senior Product Specialist. Gretchen has been with the company for a little over 2 years now. Her main role is to be a head trainer, which includes: building training material and delivering training sessions for upcoming and current clients. She’s also actively involved in the sales and marketing team by building and maintaining meaningful demo environ...2018-10-2226 minAutomating QualityEpisode 9: Effective Training Methods for Millenials with Graham O’KeeffeWelcome to the ninth 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! She’s joined by her co-host, the CEO and founder of Solabs, Philippe Gaudreau, as well as their guest for today: Graham O’Keeffe. Graham O’Keeffe is the CEO of Learn About GMP. He has been in marketing and life sciences for about 20 years and has served roles in various pharmaceutical and biotech companies, focusing mainly on compliance, quality, registry, and quality s...2018-10-1526 minSOLABS QM InsightsEpisode 8: CEO Philippe Gaudreau on Document Control Processes in Solabs QM 10In today’s episode, Ericka and her co-host-turned-guest, Philippe Gaudreau, will be discussing different scenarios when using the document control process in Solabs QM 10. Philippe is a Chemical Engineer by trade who founded Solabs almost 20 years ago. Supported by a team of strong developers and IT professionals, Philippe has managed two major iterations of his fully integrated EQMS Solabs QM. Today, the solution is offered via the web and can be hosted in the Cloud or installed on premises. The fully validated and 21 CFR Part 11 compliance solution helps Life Sciences companies automate their quality management system. ...2018-10-0828 minAutomating QualityEpisode 8: The Specificities of GCP Quality Systems with Nathalie BourgouinWelcome to the eighth 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! She’s joined by her co-host, the CEO and founder of Solabs, Philippe Gaudreau. The focus of this week’s show is the specificities of GCP quality systems. Mandy and Philippe are joined by special guest, Nahtalie Bourgouin, VP of Compliance at Skillpad. Skillpad is a sister company of Solabs and Philippe has had the pleasure of collaborating with Nathalie over the years. With more t...2018-10-0122 minSOLABS QM InsightsEpisode 7: How Permissions, Roles, and Privileges are Managed Within Solabs QM 10 with Gretchen DixsonToday’s show is focused on how user permissions, roles, and privileges are managed within Solabs QM 10. Your host is Ericka Moore, Head of Client Success at Solabs, joined by co-host Philippe Gaudreau, founder and CEO of Solabs. This week’s return guest is Gretchen Dixson, Solabs Senior Product Specialist. Gretchen has been with the company for a little over 2 years now. Her main role is to be a head trainer, which includes: building training material and delivering training sessions for upcoming and current clients. She’s also actively involved in the sales and marketing team by buildi...2018-09-2422 minAutomating QualityEpisode 7: The Philosophy of Quality with Dr. Richard PrinceWelcome to the seventh 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 to provide awareness and tactical guidance to help strategically facilitate change. The focus of today’s show is a topic that is near and dear to Mandy’s heart, and that is: the philosophy of quality. She’s joined by a very special guest, Dr. Richard Prince, President and CEO of Now Biopharma; and by her co-host, Philippe Gaudreau, founder and CEO of Solabs...2018-09-171h 03SOLABS QM InsightsEpisode 6: A High Level Overview of Solabs QM 10 Reports Offering with Kevin LangloisToday’s show is focused on a high level overview of the Solabs QM 10 reports offering. Your host is Ericka Moore, Head of Client Success at Solabs, joined by co-host Philippe Gaudreau, founder and CEO of Solabs. This week, Kevin Langlois, Head of the Engineering Group at Solabs, takes time out of his busy to schedule to join the Solabs QM Insights podcast and explain more about what reporting means with Solabs QM 10. Kevin has been with the company for the last seven years, and his main responsibilities include: the management of all technical resources (whi...2018-09-1020 minAutomating QualityEpisode 6: Data Integrity with Rich GreerWelcome to the sixth episode of Automating Quality. Today’s topic is data integrity — a current, hot-topic in the regulated space. Mandy 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 (and founder and CEO of Solabs), Philippe Gaudreau. Together, they interview their data integrity expert, Rich Greer. Rich has a ton of insight and expertise in this area, having been in the industry for around 29 years. He’s had varying roles within engineering, validatio...2018-09-0324 minSOLABS QM InsightsEpisode 5: Leveraging the Power of the Task Section Within Solabs QM 10 with Karine LoiselleToday’s show is focused on leveraging the power of the task section within Solabs QM 10. Your host is Ericka Moore, Head of Client Success at Solabs, joined by co-host Philippe Gaudreau, CEO of Solabs. Ericka’s guest this week is Karine, a Product Specialist at Solabs, who has been with the company for almost a year now. She’s a chemist with a NBA in Science and Engineering by trade. Before joining Solabs, she worked in various roles as a Quality Manager within the Pharmaceutical industry. In this episode, Karine explains the main categories of tas...2018-08-2722 minAutomating QualityEpisode 5: The Do’s and Dont's of Change Management with Rachel FountainWelcome to the fifth episode of Automating Quality. Today’s topic is change management — picking up the conversation from their first episode on the topic. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs — and together, they welcome back their guest this week, Rachel Fountain. Rachel is currently a Principal Consultant, working in the software industry with a focus on quality and risk management. She has amassed 14 years of experience in the Life Sciences industry as a quality expert — implementing change management systems and helping companies move from one automated system to another. 2018-08-2017 minSOLABS QM InsightsEpisode 4: Key Concepts of Change Control Processes Within Solabs QM 10 with Gretchen DixsonToday’s show is focused on discussing key concepts and differences between the document control and change control processes within Solabs QM 10. Your host is Ericka Moore, Head of Client Success at Solabs, joined by co-host Philippe Gaudreau, CEO of Solabs. Ericka’s guest this week is Gretchen Dixson, Solabs Senior Product Specialist. Gretchen has been with the company for about 2 years now. Her main role is to be a head trainer, which includes: building training material and delivering training sessions for upcoming and current clients. She’s also actively involved in the sales and marketi...2018-08-1324 minAutomating QualityEpisode 4: Measuring Operational Effectiveness with Alan GreathouseWelcome to the fourth episode of Automating Quality. Today’s topic is operational effectiveness. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs; and their guest this week, Alan Greathouse, Senior Director of Quality and Service Assurance with the FDA Group. Alan D. Greathouse has over 15 years of CGMP manufacturing experience focused on parenteral drug products. Throughout his career he has optimized countless manufacturing processes and excels at identifying and correcting operational inefficiencies. This episode, Mandy, Philippe, and Alan discuss operational effectiveness; what it means and how people can impr...2018-08-0620 minSOLABS QM InsightsEpisode 3: Collaborative Review Feature in Solabs QM 10 with Pascal DemersToday’s show is focused on the brand new collaborative review feature in Solabs QM 10. Your host is Ericka Moore, Head of Client Success at Solabs, joined by co-host Philippe Gaudreau, CEO of Solabs. Ericka’s guest this week is Pascal Demers, Solabs Lead Front End Developer. He was the very first, official Solabs employee, and has been when the company for almost 20 years now. He’s a software engineer by trade and works mainly coordinating core Solabs QM releases and plays a key role as a lead investigator within Solab’s customer support group. 2018-07-3022 minAutomating QualityEpisode 3: Phase Appropriate Quality with Mary SenicaWelcome to the third episode of Automating Quality. Today’s topic is phase appropriate quality — a topic that is especially relevant for anyone in the life sciences industry. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs; and industry veteran, and the Vice President of Quality and Compliance from Eirion Therapeutics, Mary Senica. In this episode, Mandy and Mary take a deep dive into a lot of critical components of quality and supporting processes. Mary gives her advice to growing companies and explains how to design processes so they’re appropriate for your organiz...2018-07-2333 minSOLABS QM InsightsEpisode 2: Key Training Functionalities in Solabs QM 10 with Martha BaileyToday’s show is focused on discussing the key concepts behind the training functionalities in Solabs QM 10. Your host is Ericka Moore, Head of Client Success at Solabs, joined by co-host Philippe Gaudreau, CEO of Solabs. This episode features Martha Bailey, Manager of Client Support. Martha has been with the company for seven years, occupying various roles. She is very passionate about helping users better understand Solabs QM 10 and has a deep knowledge on everything Solabs QM 10 has to offer. Ericka and Martha discuss the main components of the training section; how training is organized, bu...2018-07-1616 minSOLABS QM InsightsEpisode 1: Leveraging Solabs QM 10 to Build a Training Plan with Martha BaileyWelcome to the first episode of Solabs QM Insights podcast — the series that focuses on showcasing features within Solabs QM 10. Each episode features a new guest expert from Solabs about popular features. Your host is Ericka Moore, Head of Client Success at Solabs, joined by co-host Philippe Gaudreau, CEO of Solabs. In this episode, Ericka interviews Martha Bailey, Manager of Client Support, to discuss leveraging Solabs QM 10 to build a training plan. Ericka and Martha discuss how training activities can be scheduled in series to allow users to be trained on a specific on a subject or...2018-07-1122 minAutomating QualityEpisode 2: Optimizing Compliance When Implementing an Automated Training Solution with Jay TurnerWelcome to the second episode of Automating Quality. In this episode, Mandy is joined by Jay Turner of EduJay LLC. Jay’s a self-proclaimed learning and development ninja at his latest entrepreneurial venture, EduJay! He has devoted his career to improving people, processes, and programs to produce business results — everything from implementing learning management systems, to designing staff development and leadership development programs, to providing executive coaching. This episode, Jay talks to Mandy about how automated solutions can be effective in improving training and compliance, key considerations when introducing an automated solution, how deployment of a LMS...2018-07-0839 minAutomating QualityEpisode 1: Change Management with Rachel FountainWelcome to the first episode of Automating Quality. Today’s show is focused on change management — a vital topic for the Life Sciences and regulated industry. Your host is Mandy Gervasio, Sales Engineer and Quality Best Practice SME at Solabs. She is joined by her co-host, Philippe Gaudreau, CEO of Solabs. In this episode, Mandy and Philip interview Rachel Fountain. Rachel is currently a Principal Consultant, working in the software industry with a focus on quality and risk management. She has amassed 14 years of experience in the Life Sciences industry as a quality expert — implementing change...2018-06-2526 min