Being Innovative in CGMP Training While Adapting to Change

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Treating change as a normal condition of organizations and utilizing new information that is taught to our organizations are two key components to making innovations in current good manufacturing practice (CGMP) training, according to a session at the 2023 PDA/FDA Joint Regulatory Conference in Washington, DC (1).

In the session “Innovations in CGMP Training,” Nkiruka Ogbuchiekwe, senior director, Leadership, Management, and Culture, Moderna University at Moderna, and Nicole King, associate director, GMP Training Transformation at AstraZeneca, both shared their experiences with transforming companies into learning organizations and what needs to happen to get to this point.

Ogbuchiekwe explained how learning culture must evolve, as it can be described as a “shift toward manifestation of how people in an organization experience the constant exchange of values, mindsets, and behaviors the harness the power of change.” These people are also either responsible for taking advantage of change or predicting it. “Change is happening, and if we are not actively building people today to be able to understand the nature of change, then we are failing in the learning and development profession,” she said.

In an example that happened at Moderna, Ogbuchiekwe said how she was able to help the company build a learning culture and experiment with data to feed back into the new learning culture model. Although these methods worked for Moderna, she emphasized that other organizations can’t take their exact learning plan and use it somewhere else; professionals must sit down, scan the environment, and see what is going on and what needs to be accomplished.

The team ended up creating Moderna University from a case study, which was developed as an intersection of a physical campus, digital platform, industry learning center, and cultural hub. The other case study Ogbuchiekwe described went into a modern twist of a risk assessment, which is a “frame-by-frame” model with risk profile-based training curriculum. “People deserve training experiences that are aligned with what we know about how adults learn best- interactive, incorporate different ways of learning,” she said. These types of learning changes save time, create no misalignments within the organization, and can bring back collaboration and more valuable items for employees.

For King at AstraZeneca, a major issue that the organization has seen is going through new employee orientation and assigned standard operating procedures (SOPs) just to “check a box” and end up burning out. These types of onboarding activities with no context do not equal competency, understanding, or confidence, according to King, which AstraZeneca aimed to solve. Something King learned is to always demand to know the reason for the requirement for a training. “Whenever I go in somewhere and I ask to do something, sometimes a minor change, sometimes a more radical change, I always ask, ‘what is the requirement?’,” she explained.

After implementing this, one can discuss about how they interpret the requirement and what is best for the patient or organization, since this gives anyone the opportunity to reset any regulation that exists, according to King. AstraZeneca, for example, is participating in the GMP Education & Training Uplift Project (GETUP) which is fundamental in terms of how someone is trained. The manager can decide which asset is needed for an employee and then that person is trained on that solely, while SOPs are organized to be accessed at any time but not necessary in everyday training. King also described how AstraZeneca is set on creating a universal set of requirements, which is one global SOP that everyone can follow to avoid extra documentations and other iterations of the same documents.

“I know we sit in offices sometimes and we know how things are, we base it on our experience maybe 6, 7, 10, 15 years ago … please go see. Please go see your employees and ask what they remember, what’s been effective and what’s not, and start asking people ‘show me the requirement,’” King said. Additionally, being a champion for change with those who are open minded and gathering as much data as possible can also be beneficial to creating a successful learning community.

Reference

1. King, N; Ogbuchiekwe, N. Innovations in CGMP Training. Presentation at the 2023 PDA/FDA Joint Regulatory Conference, Washington, DC, Sept. 18–20, 2023.