This episode has been published on December 10th, 2019
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!
[: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. 16) of the series with Lisa, she speaks about quality agreements.
[14:55] In episode 4/6 (ep. 17) of the series with Lisa, she gives her thoughts on quality culture.
[15:37] In episode 5/6 (ep. 18) 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. 18), 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!
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