Articles & Posts

#MeToo & Time’s Up – parallels to reporting GMP compliance issues

In this article published in Pharmaceutical Online, Joanna reflects on parallels between the movements spotlighting sexual harassment issues and issues she’s seen involving those reporting GMP compliance issues. Both situations highlight exceptionally bad – if not outright illegal – behavior for which there is no good excuse and no positive outcome for anyone involved.

Flipping The Org Chart: Rethinking Where A Company’s Focus Should Be

In this article published in Pharmaceutical Online, a comment from a manufacturing operator leads to reflection on the way we currently do business making it harder for the people generating our revenue to do so. At the same time, we’re increasing the cost of producing a quality product. Is “flipping the org chart” a possible answer?

Have we driven out our people’s ability and motivation to think?

Critical thinking is an absolute necessity in a quality culture – and it sometimes conflicts with our SOPs and how we have traditionally worked. This article emanated from a series of conversations that took place at a gathering in November 2016, and is presented in two parts on Pharmaceutical Online.

Part 1 discusses the various ways we teach people that we don’t want them to think, and what it does to our organizational culture.

Part 2 discusses how we change the “we don’t want you to think” culture and develop personnel who can think on their feet.

The 5 Basic Tenets of Data Integrity & How Failures Occur

This article, published in July 2016 by Pharmaceutical Online, revisits the landmark court case that gave us the fundamental principles of data integrity – because those who can’t recall the past are condemned to repeat it.

Applying Human Performance Models in FDA-Regulated Environments

One of the things I like about delivering webinar courses is the fact that I get to speak and interact with people I might otherwise not come into contact with.  After one recent 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 as the next article in my Pharmaceutical Online series, delivered in 2 parts.

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.

Power Up Your GMP Training: Make It Relevant, Meaningful, & Engaging

Joanna’s latest article is a follow-on piece to her 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.

View the article, published on Pharmaceutical Online in March, 2016.

Who’s YOUR Yoda?

Mentoring is an important part of what we do in GMP/quality environments. This article explores points about mentoring in these situations and draws parallels to examples from Star Wars – and ends with two very important questions.

View the article, published by Pharmaceutical Online in January 2016.

Taking GMP Training from Painful to Practical

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.

This article was listed as #3 on Pharmaceutical Online‘s top 10 most read list for 2015!

But is it really human error?

After providing a web course on reacting to human error for Life Science Training Institute, Joanna was approached by Pharmaceutical Online‘s Anna Rose Welch to give an interview on the topic and how it relates to current activities in pharma.  The interview appears as a four part blog series, titled “Human Error – What Pharma Should Know and Do About it”:

Part 1 (published 16Jul15)

Part 2 (published 23Jul15)

Part 3 (published 29Jul15)

Part 4 (published 29Jul15)

To CBT or Not to CBT…It Shouldn’t Be A Question

This article, published in Pharmaceutical Online in April 2015, was inspired by a colleague’s question 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.

On Using Games in “Serious” Training

Some say that games don’t have a place in “serious” training. Such as, “We need to ensure people understand how critical/serious this topic is – games aren’t appropriate because a game won’t inspire people to take it seriously”.

I beg to disagree – through a story demonstrating how someone’s mind was changed.

I identify myself first and foremost as a “GMP Trainer” – meaning that my underlying purpose is to help people learn and apply the expectations of the regulations that govern the process of manufacturing drugs (and devices) for human use, so the products they produce are safe and benefit the patients who use them.

Pretty significant stuff – people make choices that can affect someone else’s life based on the information they receive from me. Doesn’t get much more “serious” than that, right?

The problem is that most GMP training is boring. It’s “serious” content. But we need people to “get it” – learn it, understand it, and live it. That’s the challenge.

For one particular round of GMP refresher training, we had two hours’ worth of dry information – with significant business impact – to get across to trainees who had heard it all before, and would be bored sitting through a review delivered by an instructor.

So, we chose to run it as a game. Only a game.

In the event you’re someone who is not well-versed in the use of games in training, consider some of the benefits and potential concerns associated with their use:

Using games in training is a good idea when possible because:

Games engage and involve everyone

Playing in teams allows for further discussion and reinforcement of training content

Games inject competitive energy into training courses and participants

Competition drives people to want to win, so they put effort into determining the correct answers

However, games need to be designed and managed appropriately, so that:

Everyone participates, not just those with the strongest content knowledge

Teams that aren’t doing as well as others don’t get discouraged and shut down

The game doesn’t overtake the importance of the content and become the focus of the session

Sessions were rolling along, and participants were having a GREAT time – they were moving and talking amongst themselves for the whole session.

Better yet, after the training, they were talking to others who hadn’t yet attended and telling them how great the training was.

Now, we also had a new Plant Manager (PM) that year. The PM thought GMP training should be something very different – and came prepared to tell us just that.

When the PM arrived for their scheduled session, s/he was clearly unhappy about something. Their body language just poured off of them in waves.

I was delivering that session, and sincerely hoped it wasn’t me causing that look.

The session kicked off, and through the introduction and rules, the PM’s body language didn’t change.

And then the game started.

The content of the game was a review and analysis of the prior year’s GMP deviations, common errors, observations from a variety of regulatory audits of the site, and other fundamental GMP job knowledge and information. We used this information as a basis for questions – and didn’t give anyone in the room the answers. They had to figure them out.

The session proceeded, and the PM actively participated in the game, the discussions of the answers to the questions, and why one option was better than another. And the PM’s body language changed and significantly relaxed as the game went on.

At the end, the teams were rewarded (winners for winning, and the losing team for their effort) and all the participants left to go back to work – except for the PM, who came up to me and said:

“I owe you an apology.

I came in here thinking that GMP training wasn’t being taken seriously, because I heard it was a game. I was ready to shut this down.

I clearly misunderstood what was happening.

I saw people who were fully engaged and learning from one another throughout the whole game. You addressed things we haven’t done correctly, what we should do in similar situations, and why.

I have never seen anything like this before. I think it was the best, most impactful GMP refresher I’ve ever seen.”

And it worked, too. As examples:

A QC analyst, recognizing a situation discussed in the training, stopped someone from doing something that would compromise a cleanroom and showed them the correct thing to do. Word got back to the PM, who picked up the phone, called the QC analyst and thanked them for doing the right thing.

We saw reductions in the common errors that we highlighted.

Even better, we had people actually looking forward to more GMP training – to the point of stopping me in the parking lot and asking when the next refresher would be.

This training occurred 10 years ago. Believe it or not, people still remember it, and to this day, ask to do it again.

Now, every session may not be something that can be run only as a game – but some elements of the session likely can. Most content reviews, for example. Teaching certain concepts can also benefit from game thinking.

It just takes some creative effort to make it happen and ensure the content gets across.

A Living System for Quality: Unpacking ICH Q8, Q9 & Q10

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. In this article, Pharmaceutical Online’s Anna Rose Welch interviews Joanna to gain more insight into these documents and the challenges awaiting pharma as it makes sense of the ICH Q8, Q9, and Q10 puzzle.

What Management Skills Have the Most Impact on GMP Performance?

This article, published on 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 cGMP performance effect – if the skills are not used.

This article was listed as #1 on Pharmaceutical Online‘s top 10 most read list for 2015!

Identifying cGMP Issues Caused by “Management Problems”

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.

The Road to a Culture of Quality

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.

This article was rated the sixth most popular article on Pharmaceutical Online in 2014!

Every 483 Observation Has a Training Component

This article, published on Pharmaceutical Online in June 2014, describes how a comment from an FDA inspector triggers a new way to look at 483 observations.

This article was listed as #4 on Pharmaceutical Online‘s top 10 most read list for 2015!

Human Error Is the Leading Cause of GMP Deviations – Or Is It?

This article, published in Pharmaceutical Online in May 2014, presents a discussion of underlying causes and questions to ask about errors that seem to be human errors.

This article was listed as#2 in Pharmaceutical Online’s top 10 most read list for 2014, and #9 on 2015’s top 10 list!