GxP Training Redefined?


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GxP training is a vital practice in the biopharmaceutical industry, and the best way to make sure that your program is current and aligned with your organizational goals is through a robust organizational change management (OCM) strategy. Simply put, OCM is a methodology used to ensure that stakeholders are engaged in change and the investment in the change will result in the required outcomes. In the context of GxP training, the outcome is ensuring that anyone performing GxP tasks has adequate and consistent training to meet compliance requirements.

And while GxP training has been a requirement for the biopharmaceutical industry for decades, and most organizations recycle what they have been doing year to year, your organization may be missing an opportunity for an overhaul in GxP training that can fuel change and engage your workforce in new ways. Change is good.

Before diving into GxP training, it’s important to understand what GxP means and its relevance in regulatory compliance.

GxP and Predicate Rules

The biopharmaceutical industry has its own language and GxP is one of the many acronyms we all use. While this might be a refresher for some of you, I’m also hoping to reach newcomers on this topic.

When we refer to “GxP Training” it helps to have the right context. GxP is an acronym:

G = Good

X = a variable replaced with Clinical or Manufacturing or Laboratory

P = Practice

People use the term GxP when they are referring to the regulations (laws) established by the U.S. Food and Drug Administration (FDA), which are published in the Code of Federal Regulations (CFR). Within these regulations are rules that are known collectively as the “predicate rules.”

  • Good Clinical Practice (GCPs) – requirements for clinical trials.
  • Good Manufacturing Practice (GMPs) – for product manufacturing.
  • Good Laboratory Regulations (GLPs) – requirements for research laboratories.

The predicate rules govern a wide spectrum of regulatory obligations across the diverse life sciences industry. The predicate rules also serve as standards for FDA inspections, and violation of a predicate rule will likely result in a 483 followed by a warning letter.

It is helpful to know how the CFR is organized. In general, there are 50 titles. The order of each title references chapters, parts, sections, and paragraphs. For instance, if you see 21 CFR 312.2(a) referenced, it means title 21 of the CFR, part 312, section 2, paragraph (a). Other tips to help you navigate the CFR are:

  • Title 21 is for food and drugs.
  • Chapters 200-300 are for drugs.
  • Parts, sections, and paragraphs are where you find the detailed requirements for each rule.

Some of the rules are very detailed so navigating them might take some time and practice.

I strongly recommend that you read the regulations that pertain to your roles and your specific area. Even if you have read them before, it is important to stay up to date on any regulatory changes that apply to your work. Do this in the context of where change is underway or urgently needed.

Federal Regulations and Training

Federal regulations are laws. Sponsor organizations, investigators, institutional review boards (IRBs), and independent ethics committees are obligated to comply with them. This includes the requirement to engage personnel who are effectively trained by way of education and/or prior experience and ongoing training. This is explained in the CFR below as one example.

21 CFR 312.53 Selecting investigators and monitors.

  • (a) Selecting investigators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.
  • (c)(2) Curriculum vitae. A curriculum vitae or other statement of qualifications of the investigator showing the education, training, and experience that qualifies the investigator as an expert in the clinical investigation of the drug for the use under investigation.

GxP Tasks and Learning Opportunities

Your job role may require that you perform GxP tasks; that’s shorthand for explaining you are responsible for performing a regulatory process that is linked to a predicate rule. While organizations may vary in how they organize training, GxP responsibilities should be covered by a policy and standard operating procedures (SOPs) that are included in a GxP training program.

Examples of this include development of a protocol or the monitoring of a clinical study. These are types of topics that should be covered when designing a GxP learning program. Procedures and yearly refresher programs should also be provided. The more diverse your organization, the broader your programs should be for enabling personnel to learn what they need to perform their job – regardless of the professional backgrounds they brought with them when they were hired.

While GxP training may be viewed as routine, ushering in a new technology may be an opportunity to remind people of the importance of what they do in the context of the rules. This is where relearning can drive change and engage your learners in business transformation that many functional areas are experiencing today in the industry.

GxP Training and OCM

So, most of this article is likely to be “yesterday’s news” to veterans of the industry, but let’s turn our attention to the rapid pace of change that the biopharmaceutical industry is experiencing. Routine training programs are perhaps a thing of the past as the key to organizational success is having a workforce predicted by the futurist Alvin Toffler as follows:

“The illiterate of the 21st century will not be those who cannot read and write, but those who cannot learn, unlearn, and relearn.”

To cover all the topics required within your organization, learning programs today must be more robust than ever. A brief, yearly refresher course is often not enough. A comprehensive learning strategy and program must be in place that is aligned with your organizational change management plan; this has become critical and can prevent older training courses and approaches from becoming stale and outdated. Only then can today’s biopharmaceutical organizations be compliant and poised for change and transformation that happens now more rapidly than ever.

Peter Senge said it best in his book, “The Fifth Discipline: The Art and Practice of the Learning Organization” when he described the ideal as, “organizations where people continually expand their capacity to create the results they truly desire, where new and expansive patterns of thinking are nurtured, where collective aspiration is set free, and where people are continually learning to see the whole together."

Seeing the whole as it relates to GxP and the future of the industry is fundamental to keep your organization on track with existing rules as well as emerging ones. After all, the world is changing rapidly and from our shared COVID-19 global experience, we should all have a new appreciation for how important it is to be adaptive and agile while maintaining a holistic understanding of GxP and adherence to the rules and regulations, but with an eye always toward the future.

GxP training has a lot of untapped potential for engaging your learners and improving organizational competency for a rapidly changing industry. Will your organization be ready?


Nancie-Celini-Author-Img

Nancie Celini, DrPH can be reached via email for comment and further discussion regarding the intersections of public health, pharmaceutical and regulatory science, policy, technology and learning. She has been part of the biopharmaceutical industry for four decades and is still inspired by the people who are making change happen through technology, training, improved processes, and innovation.


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