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Welcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing issues in the space and hear best in class thought leadership on various topics such as Quality, Training and Regulatory Compliance driven from an automation lens.

Welcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing issues in the space and hear best in class thought leadership on various topics such as Quality, Training and Regulatory Compliance driven from an automation lens.
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Location:

Canada

Description:

Welcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing issues in the space and hear best in class thought leadership on various topics such as Quality, Training and Regulatory Compliance driven from an automation lens.

Language:

English


Episodes

Regulatory Convergence and Its Impact on the Life Sciences Industry

10/16/2019
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Welcome 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...

Duration:00:27:53

The LIR Process and Key Considerations for Robustness with Kathryn Landes

10/2/2019
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Welcome 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...

Duration:00:53:26

Current Hot Trends in the Medical Device Industry

9/4/2019
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Welcome 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...

Duration:00:16:51

How to Leverage a Risk-Based Approach to Develop, Implement, and Maintain Your IT Programs, with Phil Becker

8/6/2019
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Welcome 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...

Duration:00:31:29

All About the Quality Risk Management Lifecycle

7/9/2019
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Welcome 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...

Duration:00:23:20

Innovation to Retrovation: Maintaining GTP in a GxP World, with Jay Turner

6/25/2019
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Welcome 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...

Duration:00:32:38

Justin Lacombe on Quality by Design

6/11/2019
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Welcome 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...

Duration:00:26:32

Michael de la Torre on GMP Inspection Analytics

5/21/2019
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Welcome 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...

Duration:00:52:04

Investigation Deviations and Non-Conformances with Lisa Helmonds Vice President from MWA Consulting

5/7/2019
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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,...

Duration:00:33:43

Management Review and Quality Metrics with Lisa Helmonds from MWA Consulting

4/23/2019
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Welcome 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...

Duration:00:24:38

Quality Culture with Lisa Helmonds from MWA Consulting

3/26/2019
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Welcome 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...

Duration:00:21:56

Quality Agreements with Lisa Helmonds from MWA Consulting

3/12/2019
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Welcome 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...

Duration:00:27:43

Continuous Improvement of Quality Management Systems

2/26/2019
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Welcome 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...

Duration:00:12:41

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

2/12/2019
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Welcome to episode 2 of the 6-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry. Last week’s episode focused on the details of...

Duration:00:22:10

Philippe Gaudreau on the Pricing Model and Client Services Offering in Solabs QM

2/5/2019
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Welcome 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...

Duration:00:23:10

Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA consulting

1/29/2019
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Welcome 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...

Duration:00:26:31

Recapping Industry Trends in 2018

12/11/2018
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Welcome 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...

Duration:00:14:19

Validating a Cloud-based Solution with Philippe Gaudreau

11/27/2018
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Welcome 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...

Duration:00:24:50

How to Build an Effective Training Assessment Program with Brian McNamara

11/13/2018
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Welcome 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...

Duration:00:30:05

Social and Collaborative Learning with Jay Turner

10/29/2018
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Welcome 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,...

Duration:00:43:02