Compliance vs. Competency: Designing CGMP Training with Performance Outcomes in Mind

December 14, 2020
Will Kanyi

Will Kanyi is Senior Training Specialist at Catalent Biologics.

Alternative approaches to training design can better address the desired performance outcomes in a GMP environment while delivering relevant information to meet regulatory compliance.

Current good manufacturing practice (CGMP) training is primarily conducted in traditional classrooms or through a computer-based training format. Typically, the training sessions are scheduled, instructor-led presentations or e-learning sessions. Unfortunately, due to time-constraints, these training formats do not provide trainees with ample opportunities to

  1. Apply the knowledge in authentic settings
  2. Demonstrate acquired skills
  3. Measure performance outcomes.

Further, learning interventions that are designed at the level one and two of learning (1) only focus on knowing and understanding compliance regulations. These interventions may not provide practical opportunities to apply CGMP in the workplace. In fact, outcomes in e-learning and instructor-led training are often measured by “seat-time” and the ability to successfully complete a comprehension assessment at the end of the session. Regrettably, this approach to CGMP training does not factor the importance of integrating authentic practice in the learning design to achieve desired performance outcomes in the workplace.

According to Chapman (2), a lack of adequate and appropriate training was mentioned as one of the common findings in FDA’s FY 2018 inspection report. Furthermore, for the last five fiscal years, it was noted that the top four citations namely: 21 Code of Federal Regulations 211.22(d), 21 CFR 211.160(b), 21 CFR 211.192 and 21 CFR 211.100(a) are frequently observed year after year (2). These observations highlight systematic organizational shortcomings and shows employees’ inability to perform their job functions in accordance with FDA’s regulations. Given the importance of complying with good manufacturing practices, training should be designed with functional competencies in mind. Ideally, learning design and delivery should account for compliance and competency goals in the training plan.

What is compliance training?

Compliance training can be described as company-mandated learning interventions that focus on informing trainees about the departmental policies, laws, and regulations. The trainings are typically recurring sessions geared toward certifying employees’ compliance in specific job functions and workplace requirements. In effect, compliance training is a “check the box” practice that ensures employees meet the minimum requirements for specific job tasks.

What is competency-based training?

Competency-based training can be described as a learning intervention that focuses on developing demonstrable skills through ‘learning by doing’ or ‘on-the-job’ training. The focus of this approach is on the trainee’s active engagement in the learning process and their ability to demonstrate an acceptable performance level on a specific task. The learning outcomes are measured by the employee’s ability to demonstrate skill performance.

Designing integrated compliance and competency training

To address both performance and regulatory requirements in a GMP environment, effective and efficient training programs should be designed to address both compliance and competency goals. An integrated approach should go beyond instructor-led presentation sessions and e-learning sessions by providing on-the-job learning opportunities that continue to develop relevant work-specific knowledge, skills, and abilities. This approach starts with understanding the desired performance outcomes in the workplace and relevant GMP requirements at job-specific levels.

Initial considerations in training design process

The process of designing a training to meet performance and regulatory needs in a GMP environment starts with defining the characteristics of the target audience. For example, designers may need to outline GMP training needs for a new hire quality assurance representative (audience) vs. new hire manufacturing associate (audience). Based on the differences in the audience’s job functions and work environment, their GMP requirements may differ. Consequently, training design and implementation should account for employees’ unique job function requirements while meeting the overall organizational needs for compliance and desired performance outcomes in the workplace.

Secondly, and of equal importance, is identifying desired performance outcomes. This process involves conducting a needs/task analysis to establish what an employee is expected to do and the resulting output. Needs/task analysis facilitates the process of identifying and defining demonstrable and measurable GMP outcomes at job-specific levels. For example, analyzing a product testing role within the quality control department may reveal that a quality assurance representative and quality assurance technician require similar lab operations skills, but desired performance outcomes may differ. Thus, job-specific competencies are key to designing a training program that supports employees’ acquisition of relevant knowledge and skills required to meet compliance and performance needs.

Thirdly, designing efficient and effective training requires writing job-specific learning objectives that support desired performance outcomes. Consider the learning objective:

(a) Be able to understand the basics of GMP.

A better approach is to write measurable and demonstrable learning objectives. For instance, (a) can be broken down to address desired performance outcomes:

(a) Be able to understand the basics of GMP

  • Manufacturing associate: be able to correctly follow standard operating procedures (SOPs) for donning frocks/scrubs for entry into secondary manufacturing areas
  • Receptionist: be able to correctly identify and dispose of waste in designated trash containers in a GMP environment.

Aligning learning outcomes with learning objectives is key to designing instructionally sound training programs and supporting employees’ performance goals and organizational compliance needs. Although the design process may seem like a burdensome undertaking, it need not be, and strategic planning beforehand is key to effectively and efficiently developing and implementing any training program.

Toward a learning culture

The industry should move beyond the conventional presentational training sessions and integrate learning by doing strategies that address practical application of knowledge in relevant job contexts. Performance outcomes are key to identifying learning objectives that support desired training goals and meet business needs. Because the goal of GMP training is to develop relevant job-specific competencies, learning interventions should be designed as a continuous process of acquiring knowledge and developing skills that support performance improvement and organizational needs.

One way to develop a continuous improvement mindset in your organization is to adapt a learning culture. In a learning culture environment, the following is done:

  1. The organization realigns its training approaches in order to focus on human performance improvement.
  2. Employees are encouraged to pursue continuous improvement as a path toward career development.
  3. Learning paths are designed to align with professional development and continuous improvement goals.

Finally, training departments have a responsibility to find ways to integrate compliance requirements into competency-based training to better equip employees to perform in GMP environments.

References

  1. D. R. Krathwohl, “A Revision of Bloom's Taxonomy: An Overview,” Theory into Practice, 41:4, 212-218, (2002) DOI: 10.1207/s15430421tip4104_2
  2. J. Chapman, FDA Analysis of The Top Drug GMP Inspection Citations in FY2018 (2019, September 4), Pharmaceutical Online, Retrieved March 1, 2020, from https://www.pharmaceuticalonline.com/doc/fda-analysis-of-the-top-drug-gmp-inspection-citations-in-fy2018-0001

About the Author

Will Kanyi is Senior Training Specialist at Catalent Biologics.