Sunday, August 5, 2012

A systematic approach to educating pharmaceutical employees

Achieve the Holy Grail of Training Effectivene

A systematic approach to educating pharmaceutical employees

As a pharmaceutical industry training professional, I am regularly asked, “How do we make training more effective?” It’s an important question, but it doesn’t have a simple answer.
Training touches most of what we do as an industry. Our operations are based on two systems—training and documentation—and everything we do hinges on our people appropriately executing our procedures. Training is what ties them together. It affects everyone in our businesses, how well our businesses run, and what results we’re able to obtain. And we know it’s not working when we see large numbers of deviations and increasing manufacturing costs.
Training effectiveness results from an effective training process—probably the least understood process in our industry. Our industry values meaningful numeric data, and we use it to define, describe, and understand our processes, but it’s difficult to identify and provide meaningful numeric data that defines and describes a training process—especially if the process is suboptimal. Worse, many of the outcomes of training hinge on an individual’s motivation and ability to learn, characteristics for which numeric data doesn’t exist. It’s not impossible to generate data around the training process, but it tends to be difficult. Anecdotal data from around the industry on evaluation practices shows that we typically focus on happiness with the training and/or whether the trainees possess knowledge, rather than on the success and effectiveness of our process.
The regulations don’t help us much, either. The FDA provides sparse guidance on training in the regulations, and what the agency does provide, while helpful, are only criteria to be met, like:
  • “Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities...are correctly performed” 21CFR820.25(a)1;
  • “Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities” 21CFR820.25(b);
  • “Training shall be in the…operations the employee performs…including the cGMP regulations and written procedures…as they relate to the employee’s functions” 21CFR211.25(a)2;
  • “Training...shall be conducted by qualified individuals on a continuing basis” 21CFR211.25(a); and
  • “Training shall be documented” 21CFR820.25(b).
Even if we meet these requirements, there’s no guarantee that our training is effective. And regulators don’t often look deeply into our training effectiveness, as long as our process runs without many deviations and product safety is assured. Training even receives a somewhat cursory review in inspections unless a particular weak spot is identified.
In reality, “training effectiveness” results from a combination of two things: a training system that includes all of the elements of an effective training process and processes that support the training system. Both must be present and working together—training effectiveness suffers if either of these elements is missing.

Elements of a Training System

To develop role-based curricula and training plans, we need to know who is responsible for performing which roles and what baseline knowledge, experience, and skills are required.
To ensure its effectiveness, we must first know what training is needed—our curricula. In simplest terms, curricula define groups of requirements to be met. We should define curricula for all employees, including requirements for onboarding (corporate, site, and departmental), ongoing GMP and safety training, and task training. Curricula should also define professional development requirements appropriate for specific positions or levels, such as leadership development training for management or specific certifications required for IT, engineering, and project management positions. Requirements for specific tasks and roles should be relatively standard; we should not define requirements based on a specific person. Finally, we should express these as role-based curricula for all levels of employees, including senior management and contract employees.
Next, we need to determine when and how to provide training and capture this information in training plans. Our departmental training plan should document the progression of tasks in the development of an employee in that role and department, and it should be structured such that training builds on previous skills acquired earlier in the development process. Then, in alignment with our defined curricula and training plans, but based on the individual’s specific experience and needs, we define an individual training plan, tailored to meet these needs. (In many cases, tailoring requirements to an individual happens through performance management and/or a personal development plan.) The combination of departmental and individual training plans allows for flexibility while individuals learn the skills to perform the department’s tasks. What each individual needs to be able to meet the requirements may vary, but the requirements and expectations should be the same for anyone performing the same task.
In order to develop role-based curricula and training plans, we need to know who is responsible for performing which roles and what baseline knowledge, experience, and skills are required. Combine that with the information used to build curricula and training plans, and we’ve identified the need for job descriptions—truly the starting point of our training system.
A job description should exist for each position, defining the role and tasks performed, as well as describing the level of performance required. Defining these expectations enables all the other elements of the training system. Job descriptions also allow us to assess an individual’s knowledge, skills, and experience against defined criteria, which helps to avoid putting individuals into positions for which they are unprepared. Organizational charts visually structure job descriptions to show reporting relationships, for the purpose of determining accountability for functions and operations. Because neither of these are currently GMP requirements in the U.S., we often consider them a non-GMP HR function; however, the EU GMPs require job descriptions and organizational charts—and a company marketing products in the EU is expected to have them.3
Because our curricula identifies who to train in what areas, and because job descriptions describe what employees need to be able to do when trained, we can now provide appropriate training activities. Training effectiveness discussions typically focus on training activities because they’re the most visible piece of the process, and we usually base our decisions on the delivery of the training activity and whether or not it met expectations. But basing judgment of our training system on this element alone overlooks the many other factors critical to our ability to provide effective training! The quality of the training activities we design, develop, and deliver directly affects training effectiveness, but the quality of training results from the combined outputs of three different process elements: instructional design, accurate content, and qualified trainers.
FIGURE 1. Components of an effective training process.
click for larger view
FIGURE 1. Components of an effective training process.
Instructional design allows us to define and build appropriate training. It is a specialized skill set that enables an instructional designer to break a task into its multiple components and determine how to effectively teach and assess each one. It begins with a needs analysis, which identifies what the training must include and accomplish—and whether training is actually needed at all. Then, the instructional designer, usually in conjunction with a subject matter expert, builds the content and practice activities and determines the most appropriate type of assessment based on the intended use of the content.
Effective training must provide accurate content. During the development process, a subject matter expert, and quality assurance where appropriate, should review training materials for accuracy. This should be part of a training content approval process, which should also include a system to control the approved content and any changes that have been made to this content. Where approved content is used on a continual basis, it should undergo periodic review and should also be reviewed when system or process changes are made, to ensure continued accuracy and appropriateness.
Next, qualified trainers must deliver our training. Qualified trainers should be subject matter experts who are able to properly perform the task, answer questions about it, and assess trainee performance. They also need interpersonal and training delivery skills. Where they deliver training will define the skills sets they need; providing one-on-one task training in an operational environment is very different than providing group training in a classroom. Trainers without training skills are just as detrimental to training effectiveness as those who have no knowledge of the content or process for which they’re providing training.
Once we’ve delivered the training, we need to ensure that it accomplishes our desired outcomes. To do this, we assess and evaluate both the trainee and the training program itself. When we assess and evaluate, we want trainees to demonstrate that they have the desired knowledge, have developed and can use the skills required to perform tasks, and, where necessary, can react appropriately to different situations. The most common assessment is a test that demonstrates knowledge, but those don’t allow trainees to demonstrate their ability to perform appropriately. The training program is typically evaluated using Donald Kirkpatrick’s Kirkpatrick Model, which helps us determine whether or not we obtained the desired results, and if not, what areas to investigate to understand why we didn’t and what to do about it.4
Last, we need to be able to provide records for our training system. We commonly think of training records as proof of training completion, but we should also include content approvals and change control, assessment results, curricula, training plans, and more. These records help demonstrate that the system is effective and training is happening appropriately, as well as providing proof of qualification to auditors.

What Processes Support the Training System?

If there is any doubt regarding management’s role in and effect on training, the FDA’s “Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations” clearly assigns responsibility for all aspects of training to management.
The most basic support to any GxP system is a standardized process documented in our operating procedures, because an effective system requires consistency of application and standards for operating. For training, our procedure should include a standard approach for how we perform and document training, how we qualify trainers, how we process and maintain our training documentation, and what we define as passing scores on knowledge assessments, along with a standardized on-boarding process through which all GMP employees are processed. Where appropriate, we should also include standardized time frames for completion in our training procedure.
Appropriate operational procedures are critical to an effective training process, because we derive much of our training content from them. Procedures should clearly define processes, responsibilities, and tasks to an appropriate level of detail, providing standard performance requirements for each process. Ambiguity of performance requirements or responsibilities, or the lack of documented processes, causes training effectiveness to suffer—it’s difficult to teach, learn, or assess a process that everyone does differently. However, if procedures provide on-the-job reinforcement of items learned in training—even wording as simple as “at this point in the investigation, perform a root cause analysis to identify the root cause of the problem”—they automatically improve training effectiveness, because they tie directly to what was learned and define when to use it.
Systems and repositories—preferably electronic—ensure that we can manage the process and the associated materials and records, and access the information we need. While this can be done in a well-managed paper system, electronic learning management systems and learning content management systems make this process much easier to manage. For example, the ability to easily access records enables us to quickly verify an operator’s qualification on a specific task. Having a location where people can access controlled, approved training materials and information provides the same benefit as a controlled documentation system: access to current, consistent information.

The Most Critical Factor

Of all the system elements, management support has the largest impact on training effectiveness. So what does “management support” mean? In a word: expectations. Our management teams should expect the following:
  • Training occurs, is done well, and is completed on time;
  • Results are measured, reported, and acted on appropriately;
  • Training is meaningful, and skills learned in training are appropriately applied to operations;
  • All parts of the training system and support processes are in place and functioning appropriately, and people are accountable for their parts of the process;
  • Training helps meet the goals of the business; and
  • Training is part of the job and part of ongoing employee performance management processes.
If there is any doubt regarding management’s role in and effect on training, the FDA’s “Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations” clearly assigns responsibility for all aspects of training to management:
“Under a quality system, managers are expected to establish training programs that include the following:
  • Evaluation of training needs
  • Provision of training to satisfy these needs
  • Evaluation of effectiveness of training
  • Documentation of training and/or re-training.
When operating in a robust quality system environment, it is important that managers verify that skills gained from training are implemented in day-to-day performance.”5
The guidance also requires senior leadership and management to define and provide policies, procedures, and desired work culture, and prescribes these topics for inclusion in our training courses and content. So, the FDA expects management to have a vested interest in the content, the quality, and the process of training.
Finally, consider this: The attitude the organization’s leadership takes toward training—particularly their own training requirements—sets a powerful example, either good or bad, for the rest of the organization. Training takes time away from operations and is often viewed as a necessary evil. But, when employees see leadership attending GMP refreshers or completing applicable procedural training, they understand that training is a business activity that has value and is worth the time. However, if people see their leadership regularly excused from or habitually late in completing training, they think, “Training isn’t important enough for management to spend their time on.” Training, in their eyes, is now a punishment for those at lower levels, one that can be bypassed by management in favor of other activities.

Achieving the Holy Grail

So this is why improving training effectiveness doesn’t have a simple answer. We’re dealing with a fundamental business process that touches many parts of the organization, along with other processes built upon or around it.
At heart, improving training effectiveness is about problem solving and continuous improvement, and it will likely lead to changes in systems, processes, and procedures, as well as training practices. But finally achieving effective training “nirvana” provides measurable benefits to the business: Imagine having competent and motivated employees making fewer errors and better decisions, along with fewer wasted resources, increased efficiency, and, ultimately, more compliant and more productive operations. Who’d have thought a necessary evil could be so positive?


  1. U.S. Government Printing Office. United States Code of Federal Regulations, 21 CFR 820.25: Quality System Regulation: Personnel. Updated April 1, 2011. Available at: Accessed June 7, 2012.
  2. U.S. Government Printing Office. United States Code of Federal Regulations, 21 FR 211.25: Current Good Manufacturing Practice for Finished Pharmaceuticals: Personnel Qualification. Updated April 1, 2011. Available at: Accessed June 7, 2012.
  3. European Commission Health and Consumers Directorate-General. EudraLex Volume 4: EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Part 1, Chapter 2. Personnel, Section 2.2. Dec. 2010. Available at: Accessed June 7, 2012.
  4. Kirkpatrick Donald L. The Kirkpatrick Philosophy. Kirkpatrick Partners website. Available at: Accessed June 7, 2012.
  5. U.S. Food and Drug Administration. Guidance for Industry: Quality systems approach to pharmaceutical CGMP regulations. September 2006. Available at: Accessed June 7, 2012.

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