7. Free Training Resources
JGTA Whitepaper: “The 5 Basic Tenets of Data Integrity – and How Failures Occur”
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Description
Data is the lifeblood of the GxP industries. This article, published in Pharmaceutical Online, revisits the landmark court case that gave us the fundamental principles of data integrity, and describes common data integrity issues, highlighting where in the process they can occur and what contributes to them. Because those who can’t remember the past are condemned to repeat it.
JGTA Whitepaper: “Identifying CGMP Issues Caused by ‘Management Problems'”
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Description
This article, published in Pharmaceutical Online in December 2014, introduces a discussion of “Management Problems” and how they can lead to cGMP issues, including how they differ from “Personnel Errors” and why they are so difficult to identify, along with suggestions for avoiding these issues. Now available as a whitepaper!
JGTA Whitepaper: “Taking GMP Training from Painful to Practical”
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Description
Have you ever wanted to make your GMP training more relevant to daily operations? Explore suggestions for strengthening how we communicate the “GMP rules of the road” in the different types of training we do – onboarding, OJT, and refresher – in this article, published by Pharmaceutical Online in November 2015, now available as a whitepaper.
This article was listed as #3 on Pharmaceutical Online‘s top 10 most read list for 2015!
JGTA Whitepaper: “Powering Up Your GMP Training”
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Description
This article, published on Pharmaceutical Online in March, 2016, is a follow-on piece to Joanna’s popular 2015 article on making GMP training more practical. In this piece, you’ll find tips for making GMP training relevant and meaningful, examples of how that goes wrong, and some suggestions and sources that will help make GMP refresher training something that engages trainees. Now available as a whitepaper!
JGTA Whitepaper: “Who’s Your Yoda?”
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Description
Mentoring is an important part of what we do in GMP/quality environments. This article, published by Pharmaceutical Online in January 2016, explores points about mentoring in these situations and draws parallels to examples from Star Wars – and ends with two very important questions. Now available as a whitepaper!
JGTA Whitepaper: “Applying Human Performance Models in FDA Regulated Environments”
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Description
One of the things I like about delivering web courses is that I get to speak and interact with people I might otherwise not come into contact with. After a webinar on reacting to human error, one of the attendees had a discussion with their management – and had questions from that meeting they sent me, looking for some guidance.
The exercise of applying the human performance models to the GMP environment was well worth the time, and led to a broader discussion of melding the two worlds.
This white paper combines the two halves of the article as published on Pharmaceutical Online:
- Part 1 addresses regulatory approach, confidentiality, and correcting an actual FDA 483 observation addressing human performance.
- Part 2 explains what “human errors” truly are, when CAPA is (or should be) required, and how to get started using human performance improvement tools.
JGTA Whitepaper: “Every 483 Observation Has a Training Component”
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Description
Published on Pharmaceutical Online in June 2014, this article (listed as #4 on Pharmaceutical Online‘s top 10 most read list for 2015) describes how a comment from an FDA inspector triggers a new way to look at 483 observations to find the underlying training deficiency that led or contributed to each citing. Now available as a whitepaper!
JGTA Whitepaper: “Human Error is the Leading Cause of GMP Deviations – Or Is It?”
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Description
Published in Pharmaceutical Online in May 2014, this article presents a discussion of underlying causes and questions to ask about errors that seem at first to be human errors. Now available as a whitepaper!
This article was twice listed in Pharmaceutical Online‘s top 10 most read list – #2 for 2014, and #9 in 2015!
JGTA Whitepaper: “To CBT or Not to CBT…It Shouldn’t Be A Question”
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Description
Published in Pharmaceutical Online in April 2015, this article was inspired by a question from a colleague about whether performance assessments as part of training are industry standard.
The article explores the benefits of competency-based training, how it aligns with current regulatory expectations, and the benefits to the business of instituting competency-based training. Now available as a whitepaper!
JGTA Whitepaper: “What Management Skills Have the Most Impact on GMP Performance?”
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Description
This article, originally published by Pharmaceutical Online in February 2015, looks at management skills required for success in a GMP environment. While the article does not include a complete list of management skills, it addresses those that impact GMP performance, and identifies what can happen – in terms of the effect on performance of GMP tasks – if the skills are not used. Now available as a whitepaper!
This article was #1 on Pharmaceutical Online‘s top 10 most read list for 2015!
JGTA Whitepaper: “The Road to a Culture of Quality”
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Description
This article, published on Pharmaceutical Online in September 2014, discusses the elements required to create a culture of quality, and those organizational behaviors that impede a functional quality culture. Now available as a whitepaper!
This article was the #6 most read on Pharmaceutical Online in 2014!
JGTA Whitepaper: "What Does ICH Q10 Look Like In Practice?"
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Description
This whitepaper provides a practical view of an ICH Q10 pharmaceutical quality management system (QMS), discussing each element expected in a QMS, along with how they interact and feed into one another.
All of this is used to build, in stages, a diagram of a fully functioning ICH Q10 QMS. The whitepaper concludes with questions to get you thinking about your own QMS.
How does your QMS compare?
SOP Training & Assessment Requirements Decision Tree
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Description
This file includes a decision tree that will help guide your decisions around what type of training should be done on SOPs, along with what type of assessment should be utilized for the training, and how that training should be documented.
It also provides a distinction between initial and revision training, as well as levels and types of changes, and the impact each has on the training type and assessment needs.
We hope you find this useful!
Article: “Job Aids Slowly Evolve from Paper to Electronic”
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Description
“Job Aids Slowly Evolve from Paper to Electronic, Move from Shop Floor to Office Suites” is an article written by PDA’s Walter Morris that was published in the October 2012 issue of the PDA Letter, ahead of the 2012 PDA Biennial Training Conference.
Joanna is quoted, along with four other PDA Biennial Training Conference committee members, in a discussion about the current and future use of job aids, including the variety of forms they appear in and how they are served out for use in a variety of environments.
How can you incorporate these ideas into your practices?
GMP Baseball Game Instructions
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Description
This file provides a list of required supplies, trainer/facilitator instructions, and participant instructions for playing a game of GMP Baseball.
Use this activity for a lively content review — it gets people are up and moving, traveling around the bases and scoring runs, there’s a pitcher actually pitching, and teams cheering on the action! Play as many innings as you have questions to fill.
This activity can be used as a review of GMP/QSR content for a GMP refresher, or as a review for any classroom course. Supply your own questions, or use some of our question sets for content.
Try it — it’s a lot of fun to watch, and it’s a great way to end a course, engaging the participants and leaving them energized at the end of the session.
Article: “Achieve the Holy Grail of Training Effectiveness”
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Description
“Achieve the Holy Grail of Training Effectiveness” in an article that was published in the June/July 2012 issue of Pharmaceutical Formulation & Quality.
This article describes the elements of a training system and the support systems required for effective training — including how the elements work together to drive to the end result of the training system: Qualified personnel.
Use the points in the article to assess your own process, and don’t be afraid to contact us if you have questions, or need assistance.
Article: “5 Questions to Ask Yourself Before the Inspectors Do”
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Description
“5 Questions to Ask Yourself Before the Inspectors Do” is an article written by Trisha Gladd, editor of Pharmaceutical Online. It appeared as the March 10, 2014 “From the Editor” feature.
The basis of the article is Trisha’s interview with Joanna, reviewing trends in FDA inspections and observations, and discussing five questions companies should reflect on, to help them address these critical areas.
How would you answer the five questions?
Blog Post: "Human Error – What Pharma Should Know and Do About It"
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Please enjoy this article in which Joanna is interviewed by Anna Rose Welch of Pharmaceutical Online. It appeared as a 4-part blog posting in 2015.
Blog Post "Unpacking ICH Q8, 9 & 10"
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As organizations strive for Quality by Design compliance, operations will need to be aligned with and meet the expectations set in the ICH Q8, Q9, and Q10 guidance documents. I reached out to LSTI expert, Joanna Gallant, president of Joanna Gallant Training Associates, to gain more insight into these documents and the challenges awaiting pharma as it makes sense of the ICH Q8, Q9, and Q10 puzzle.
JGTA Whitepaper "Identifying and Preventing Common Data Integrity Issues"
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Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today. Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality. The integrity and trustworthiness of the data provides a baseline for the regulators’ opinion of the personnel and the company as a whole.
This article was published in GXP Lifeline in 2016, was a top 25 article in 2016 & 2017, and as a result, was reissued in 2018.