Let's Combinate - Drugs + Devices15 Mar 2023

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

On this episode, I was joined by Joanna Gallant of JGTA. Joanna walks through:

Training programs at companies that had consent decrees
The difference between good training and bad GMP training
Competence in knowledge work
Human Error

Joanna Gallant is an experienced, solutions-driven Quality and training professional who has spent more than 30 years in pharmaceutical, biotechnology, tissue culture and medical device development and manufacturing environments. Over her career, she has provided regulatory, technical, skill, and management development training support to all operations functions, as well as IT, R&D, Customer Service and senior management. Now, as a training system consultant, she works with clients to design and deliver custom training and build/remediate training systems, including in support of regulatory audit observations and commitments. Joanna has been a GMP TEA member since 2001, and now serves on the Board of Directors as an Advisor. She is one of the founders of the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011. Joanna writes a popular article series for Pharmaceutical Online on the people side of pharma & GMP, provides monthly interactive web courses through LifeScience Training Institute, and through her JGTA, LLC business, authored GMP Training Can Be Fun! along with an ever-expanding line of GMP training games and activities.

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Episoder(248)

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236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

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