Guest Column | September 10, 2018

Regulatory GMP Expectations For Learning, Training, & Performance In Pharma/Biopharma

By James Vesper, Ph.D., MPH, ValSource, LLC

Training is one of the most important investments a firm can make. You don’t train just for the sake of doing it – if so, your firm would be an educational institution and not a manufacturer. Rather, training must be linked with the organization’s goals. Through training, people develop knowledge and skills so they can safely, effectively, and consistently perform their jobs.

If the performance is the desired outcome, training is only part of the equation. The person needs to have the underlying capacity and capability to do the assigned task. Also, she needs to have the right tools to support the performance. This includes the wrenches and instruments a repair technician uses, but it also includes job aids and performance supports — often incorporated into controlled documents like batch records or made available as short demonstration videos in new, integrated electronic batch records that use notebook or tablet computers. These informational tools can change the training model from “just in case” to “just in time.”

A further innovation has been e-learning. With this method of delivery, pharmaceutical companies can provide consistent training to their staff members. This training is delivered through online courses. For example, a well-designed e-learning course on drug-modeling software, as might be used by a research and development department, can impart the knowledge and skills needed to use the software efficiently. (A key phrase in the previous sentence is “well-designed.” Often, e-learning is simply an animated slide presentation that users march through without gaining any real, value-adding knowledge.)

Training Versus Learning

In recent years, some pharma and biopharma organizations have changed the names of their training departments to incorporate the word “learning.” For example, one large firm formerly called their corporate group “Training and Continual Improvement;” now it is “Organizational Learning.” A unit in the WHO changed its name from “Global Training Network” to “Global Learning Opportunities.”

Some may see this as a trivial play on words. Others, however, have realized that if the change from “training” to “learning” is accompanied by a fundamental change in philosophy, it can have a significant positive effect.

Some of the differences between a more traditional “training” model and a more progressive “learning” approach include:

  • Training is “top down” and localized; learning is distributed and occurs everywhere.
  • Training presentations are replaced with learning opportunities; trainers become facilitators.
  • Learning often involves real-life lessons rather than abstract case studies.
  • Training is a “push” system; learning is a “pull” system.
  • Trainees become learners. 
  • Mentors become learners; learners become mentors.
  • Formal training expands to include informal learning.

Key Elements Of A Learning/Training Program

Curricula or learning plans are an important component of a well-functioning learning (or training) program, showing learners, supervisors, and regulatory inspectors the path of learning to develop knowledge and skills. A well-defined curriculum will cover a person from the point of entry into a position (with new employee orientation, for example) to when the person has achieved and is enhancing his competence and expertise. Such curricula can also aid employees returning to work after extended absences.

From the curricula, training courses and learning opportunities can be developed. These courses must be approved by subject matter experts — and, in some cases, by the quality unit — before being used. The learning opportunities need to cover the tasks the person performs as well as the applicable GMPs. Training on safety and other mandated training topics would be included in the curricula.

Key people such as heads of production, quality assurance, microbiology, and quality control laboratories; those who release or certify products (e.g., “responsible person” or “qualified person”); and consultants may need to have special, documented qualifications or licenses. Regulators, in particular, expect people in these roles to be able to demonstrate they have the requisite knowledge and experience to carry out their responsibilities.

To develop competent performers, they must have a mental model of what they are doing. Simply put, they need the big picture of the process and how their work fits into that picture. That picture must include a clear vision of what specifically they are doing, what a good product looks like, and how they can negatively impact the product or process.

Instructors, trainers, and mentors must be qualified. This qualification, in practice, considers two things: knowledge and skills in the domain to be trained (e.g., aseptic technique, calibrating a scale, setting up a packaging line) and practical knowledge and skills of training, coaching, and mentoring.

Assessment and evaluation need to be part of training. Learning professionals usually use “assessment” when looking at someone’s performance, as shown by a paper test or demonstration of performance. “Evaluation” is used when looking at things — like the learner’s acceptance of a training course or the effectiveness of a learning program. An example is a laboratory technician showing they both understand the theory behind an assay and can execute the assay competently.

The learning program needs to be defined in a procedure setting out roles and responsibilities, the requirements for developing courses, how instructors are qualified, how formal and informal learning is documented, and when formal, structured learning opportunities are to be provided.

The Canadian GMPs (published in March 2018) say it best in the Rationale summary; these are the only GMPs that emphasize an intangible quality, mindset:

Who you hire is one of the most important elements in any pharmaceutical operation. Without proper staff with a quality mindset and training, it is almost impossible to fabricate package/label, test or store good quality drugs.

It is essential that only qualified staff supervise the fabrication of drugs. These operations are highly technical in nature and require constant vigilance, attention to detail, and a high degree of employee competence. The reason products often fail to meet required standards is because of poorly trained staff or a lack of understanding of the importance of production control.

GMP Expectations

In the GMP regulations of the FDA, European Medicines Agency (EMA), and Health Canada, one can find these requirements that cover learning, training, and performance:

1. There are an adequate number of qualified people to safely and effectively perform the required tasks.

2. Tasks, roles, and responsibilities are defined in job descriptions and organization charts.

3. Personnel are trained and/or otherwise qualified in the procedures and methods they use and the tasks they perform.

4. Personnel learn the GMP concepts and regulations that apply to what they do; there are periodic (annual) “refreshers” of GMP requirements that are relevant to what the personnel do.

5. Key personnel (including consultants and contractors) have the professional, educational, and experiential credentials required.

6. The learning program is defined by a procedure and learning plan, learning events like training and assessment results are documented, and the effectiveness of the training is evaluated.

7. Learning events are conducted by qualified personnel.

8. Supervisors and management have training that is appropriate to their functions.

Having a competent, professional workforce is essential to meeting the dual goals of business requirements and regulatory expectations. With a coherent plan and a well-structured learning system that is focused on performance, a pharma firm can efficiently accomplish both.

This article was adapted from the book GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry (Fifth Edition) written by James Vesper and Tim Sandle and published by PDA/DHI Publications (2018).

About The Author:
James Vesper is director of ValSource Learning Solutions and has more than 35 years of experience in the pharmaceutical industry. He worked at Eli Lilly and Company before establishing the consulting firm LearningPlus. Vesper joined ValSource in 2017 and designs training courses and performance solutions. He has worked around the world at pharma and biopharma firms, trained inspectors from a number of health authorities, and written five books. Vesper received his Ph.D. in education from Murdoch University (Perth, Western Australia) and his MPH from the University of Michigan School of Public Health (Ann Arbor). You can reach him at