Hardware Podcasts

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

Let's Combinate · 15 Mar 2023 · 28m

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
JGTA, LLC, Worcester Polytechnic Institute, Boston University School of Medicine, LifeScience Training Institute
Products
GMP Training Can Be Fun!
Also
Pharmaceutical Online

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