By Joanna Gallant, owner/president, Joanna Gallant Training Associates, LLC
A few months ago, I contributed an article on making GMP training more practical. In this article, we’ll expand on the topic and look at making GMP training more engaging and meaningful — to benefit both the business and its personnel.
Why is training on the content of the regulations important to the business?
First and foremost, it’s a legal requirement. The GMPs state that all individuals must receive training on the regulations — on an initial and ongoing basis — as those regulations apply to their jobs, as a basic personnel qualification. From 21 CFR 211.25(a):
Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations…) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
While 21 CFR 211 applies to the bio/pharmaceutical environment, the same expectation exists for medical devices, even though it’s not explicitly stated in the regulations. The Quality System Regulation (QSR) uses the term “background,” which can be interpreted as having knowledge of the industry requirements (the regulations) that enables correct — including compliant — performance. From 21 CFR 820.25(a):
Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
But beyond the legal requirement, a working knowledge of regulatory requirements is foundational to everything we do. The regulations define specific elements related to our processes, the information we collect, and what records we keep, as examples, and we should expect people to at least be familiar with them so we can meet these basic expectations in daily operations.
What key topics should be covered in GMP training?
If we expect GMP training to enable compliant task performance, onboarding should then prepare personnel to work in a GMP environment. That means we need to educate personnel on both the basic elements of this environment and our expectations of them related to these elements, including, at a minimum:
- What the regulations require, why, and why we’re regulated
- An overview of the product development and production process, the products and/or services the company provides, and how their role supports the process
- The importance of, and expectations relating to, procedures, training, documentation, and data integrity
- How to react to deviations or nonconformances
- Validation and change control basics relating to how we prepare processes and equipment, and why changes can’t be made on the fly
- The importance of contamination control, and the employee’s role in it
- Regulatory audits and expectations of personnel in these situations
- Basic information about enforcement, including the impact of compliance failures
Then, refreshers should build on these topics, providing additional topical information or reminders of expectations, identifying improvement opportunities, or enabling personnel to expand their knowledge and understanding of the GMP environment. Topics for refresher training should include:
- New or changed regulatory information, expectations, trends, and current hot topics
- Reviews of portions of the regulations that have been challenging or not executed properly — in relation to audit observations, deviation/nonconformance trends, etc.
- Other topics that can benefit internal operations/processes, including management- or operator-focused topics as needed
Where do companies usually go wrong with GMP training, and why?
The most significant and frequent misstep with GMP training is failing to make it engaging or meaningful to the attendees. It often goes wrong in one of these areas:
- Companies fail to enable personnel to connect GMP training to what they do. Let’s be honest. Herding people into a room and reading regulation content to them doesn’t energize anyone, nor does it provide meaning or context to the requirements. Then, we make general, nebulous statements — like “Everyone is responsible for quality” — without providing specific expectations of how that should translate into individual actions (“You should…”). As a result, people can’t relate the requirements to the tasks they perform, or understand the expectations that apply to them individually. Additionally, we sometimes use presenters who don’t have the necessary background to provide GMP training — they may provide incorrect information, or they can’t speak to the GMP/operational environment. This undercuts the potential effectiveness or any benefits that may have been seen as a result of the training.
- Companies use the same material every time. Whether it’s a video, e-learning module, or the same presentation reviewing the content of the GMPs, people recognize when they see the same thing repeatedly. So if we don’t care enough about GMP training to put effort into it, why should they care about it either?
- GMP training isn’t viewed as something that can provide results or benefits. In these worst-case scenarios, it’s not considered an important activity, and it will lack support in any number of ways. Maybe the GMP training function isn’t resourced appropriately — someone has “GMP training” as one task in a long list of responsibilities, and as such, there’s no real focus on it or how to do it well. Sometimes, training is infrequent, and directed to be as short as possible, because people are too busy with “real” work to take “time off” for training. Or, personnel aren’t expected to apply what they’ve learned to their jobs; even worse, their management undercuts what was covered, changing messages or expectations. All of these send the message that GMP training isn’t important.
When company management and the GMP training function work together, amazing things can happen, but things go badly when they’re not on the same page.
So how else could GMP training be done?
Many GMP refreshers cover knowledge or awareness content, which can be difficult to make meaningful, relevant, engaging, and interactive — but it is possible. Consider the following examples.
I recently worked with a company where there was a disconnect between the senior leadership’s expectations for quality in operations and the understanding of those expectations among the operational personnel. So, for a GMP refresher, we asked the CEO to speak for about 5 minutes on his views and expectations for quality in operations, and we recorded him. The video was distributed to the supervisors, along with discussion questions related to where the expectations for quality weren’t being met and what must be done differently to enable them to be met, plus a short set of instructions on how to run the session. Each supervisor then held a group meeting, where the group watched the video and discussed the questions. To receive training credit, each group had to provide a written summary of their discussion, along with a signed training record listing the personnel who participated.
Did this refresher discuss specific GMP content? No, but it had people talking about quality and meeting compliance requirements, and where those were at risk, making it clear that quality is a critical success factor for the business. It also supported a number of elements of the quality system and led to quality and compliance improvements, as follows:
- Management responsibility/communication/support for the quality system: The video enabled direct communication of quality and compliance expectations from senior leadership to all personnel in a consistent fashion. For some, it was the first time they heard senior leadership talk about quality expectations. For others, it was their first time hearing quality expectations at all.
- Continuous improvement: Personnel participated in problem-solving and continuous improvement discussions targeted at meeting quality and compliance expectations at the workgroup level. This led to the grass-roots levels of the organization identifying compliance risks and actionable improvement ideas. Some improvements needed management support to accomplish, but others were things they could implement themselves.
- Risk management: Submitting summaries of the discussions enabled creation of a consolidated list of potential compliance issues, risks, and quality improvement ideas that was then provided to company leadership. This gave management specific information about problems that needed to be addressed throughout the organization, and suggestions from the personnel living in the situations on how to improve them.
Has your GMP training become boring or rote? Looking for ideas to make it more empowering, influential, and meaningful?
Register for Joanna Gallant’s’s upcoming online seminar:
"Powering Up" Your GMP Training — Make Training Fun!
March 23, 2016 | 1:00-2:30 PM EDT
An easy example is reviewing regulation content. Convert the content into questions, and then fit the questions into a format that requires interaction — like turning it into a game. Jeopardy is a popular game format, but there are a number of others that can be used. Options include things like board games, sports activities, guessing games, e-learning activities, crossword puzzles, word searches, and more. It requires some creativity, planning, and keeping focused on the goal: getting people to use their content knowledge.
As a more challenging example, one year we wanted to address the Prescription Drug User Fee Act (PDUFA), because of the impact to the business — specifically, the fees we pay to register facilities, existing products, and file for new products/new indications — and “PDUFA Poker” was born. Trainees were given a quantity of money (representing their operating budget), and they had to make business decisions based on risk/potential reward, follow rules to stay in the game, and build the best poker hand, but still have money left so their company could function. It created an awareness of what it took to be in the pharmaceutical industry, how to market new product, and the costs and impact of failures.
What are some strategies for planning and executing successful GMP training?
Most importantly, recognize that meaningful, engaging GMP training doesn’t happen by chance — it requires someone putting in the effort to make it so. Some of the following tips should help:
- Define and stick to a schedule. Determine how many refreshers you’ll do and when, and then make people aware of the schedule. This way, everyone can plan for it. The training people know when they’ll need to have content ready and sessions scheduled, and the functional areas can plan their resources and activities appropriately because they know when things will be happening.
- Don’t reuse materials or repeat game formats in subsequent refreshers. Even something attendees enjoyed wears thin after a while. (“We’re playing baseball again??”) Keep the content and how you present it fresh for more impact.
- Identify possible topic ideas — don’t expect people to give them to you. Having a list of possible topic ideas with some background as to why they would be beneficial makes GMP refresher topic conversations easier, because there is a starting point to trigger discussion.
- Focus on important topics and regulatory trends (like data integrity, for example). If there are issues/trends in areas, you can bet the same areas will turn up as topics in your next inspection, so use GMP training to help prepare for them!
- Pay attention to what’s happening in your business internally, and use these areas for GMP training topics and content. It will help make improvements in the business/operations.
- Make the content interactive and engaging. People learn more from participating in experiences than from lectures and videos.
- Find the right people to deliver the training. Not everyone is qualified to or capable of delivering GMP training! Some lack training skills, others lack content knowledge. Both are necessary for training to be done well. And don’t be afraid to bring in an outside voice — like consultants, ex-FDA/regulatory agency personnel, or recognized industry experts — because sometimes it helps to hear from someone outside the company. Their status lends extra credibility to the messages.
What are some good sources of information for GMP training?
Above and beyond the regulations themselves, there are a variety of sources for information that can be used in GMP training, including:
- Industry/national/international news outlets are a great source for case studies on a variety of topics.
- The FDA’s website is a goldmine. It contains:
- Warning letters, 483s, and other enforcement actions that can serve as examples, case studies, and more
- Guidance documents, compliance program guides, and the Investigations Operations Manual that provide current expectations and what FDA will look for in inspections
- Annual summaries of inspection observations by sector (drug, device, food, etc.) provide trends and top areas of focus
- A repository of presentations FDA personnel have given in a variety of forums provides current information on activities and perspectives
- International regulations, guidance, and laws. Many companies work in international markets, so we should be educating personnel on the GMPs and other requirements for those markets.
- Internal quality processes people should understand how the process impacts them, or how they impact the process.
- Internal data — like internal issues and performance metrics — along with information from your quality personnel, internal auditors, and operations management, is a great source for possible topics that should be discussed in GMP training.
When GMP training is meaningful and engaging, it allows personnel to connect to the expectations on a personal level, which means they then understand more and translate that into their job tasks.
The best way I’ve ever heard the GMP mindset described was as “religion” — and it fits. The Merriam-Webster Dictionary defines religion as an institutionalized system of attitudes, beliefs, and practices held to with vigor (paraphrased). Isn’t that how we want people to view GMP?
Meaningful, engaging GMP training will help personnel “get religion” and will ultimately lead to better, more compliant business activities. Give it a try — you have nothing to lose and everything to gain.