# 076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-03-15
- Length: 28m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-15-076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/076---GMP-Training--Competence--Human-Error-and-Mentorship-with-Joanna-Gallant-e1vspkp

## Summary

Joanna Gallant of JGTA, LLC, a training consultant with 30 years in pharma and medical device industries, discusses the critical gap between being 'trained' and being 'competent' in GMP environments. She explains how companies under consent decree often fail because they lack robust training systems, leading to reliance on consultants who themselves are poorly trained in GMP training methodologies. Gallant advocates for structured On-the-Job Training (OJT) and mentoring for white-collar knowledge work, using mock batch records to assess ability to perform rather than just reading SOPs. She highlights that human error in complex tasks stems from inadequate background understanding and poor SOP detail, requiring a shift from rote reading to active assessment and mentorship.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-15-076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant#t=0) Introduction: Subi Seday and Joanna Gallant of JGTA, LLC
- [2:18](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-15-076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant#t=138) Joanna Gallant's Career: From Product Development to Consulting
- [7:04](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-15-076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant#t=424) Training Consultants During a Consent Decree
- [10:03](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-15-076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant#t=603) The Difference Between Being Trained and Being Competent
- [13:17](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-15-076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant#t=797) Assessing White-Collar Error and Ability to Perform
- [17:06](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-15-076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant#t=1026) Structured OJT and Mock Batch Records
- [20:18](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-15-076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant#t=1218) Avoiding the 'Pile of SOPs' Onboarding Trap
- [23:09](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-15-076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant#t=1389) SOP Detail vs. Background Knowledge in Human Error
- [25:41](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-15-076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant#t=1541) Formal vs. Informal Mentoring Programs

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)

## Most relevant to

early-stage companies

## Mentioned

- JGTA, LLC (company)
- Worcester Polytechnic Institute (company)
- Boston University School of Medicine (company)
- Pharmaceutical Online (other)
- LifeScience Training Institute (company)
- GMP Training Can Be Fun! (product)

## Related episodes from other shows

- [Thrilled to Be Asked: How to Build Leaders on the Frontline w/ Gayle Noakes](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2020-12-01-thrilled-to-be-asked-how-to-build-leaders-on-the-frontline-w-gayle-noakes) (The Manufacturing Executive)
- [Meet a Guru: Erica Loring](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring) (Global Medical Device Podcast)
- [Addressing the 'Who, What, When' of Quality in the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-08-addressing-the-who-what-when-of-quality-in-the-medical-device-industry) (Global Medical Device Podcast)
- [Meet a Guru: Taylor Brown](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-01-meet-a-guru-taylor-brown) (Global Medical Device Podcast)
- [#370: Meet a Guru: Jamie Bihary](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-30-370-meet-a-guru-jamie-bihary) (Global Medical Device Podcast)

## Citing this page

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