GMP
Rebecca Beausang
December 7, 2025
A detailed review of recent FDA warning letters reveals a clear and ongoing trend: insufficient personnel training remains a primary contributor to regulatory noncompliance. Despite significant investment in quality systems, documentation tools, and digital platforms, many organisations continue to overlook one of the simplest yet most critical compliance foundations, competent, well-trained staff.
In regulated environments governed by Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), training is not an administrative formality. It is a regulatory requirement and a key preventive control. In several recent FDA citations, investigators linked deviations in recordkeeping, data integrity, and system management directly to under-trained or unqualified personnel. These findings underline the fact that the best-designed procedures are only as strong as the people implementing them.
This article reviews examples of FDA findings tied to training failures, outlines the broader consequences of poor GxP training, and introduces a practical solution, the Introduction to FDA 21 CFR Part 11 Online Course, to help organisations strengthen their compliance programs.
Across numerous FDA warning letters, training deficiencies appear either as a direct violation or as part of a broader systemic failure. Section 21 CFR 211.25(a) clearly states that every person engaged in GMP activities must have the education, training, and experience required to perform their assigned functions. When this requirement is neglected, the resulting issues often cascade into other parts of the quality system.
In one case, the FDA observed that production personnel responsible for batch record completion and review had not received documented training on the procedures they were executing. The firm’s quality unit had not established a structured training matrix, and several employees were performing GMP-critical tasks without evidence of qualification. During the inspection, it became evident that deviations in batch records, including incomplete entries and missing signatures, were due to a lack of understanding of documentation requirements.
Another inspection revealed a contract testing laboratory where analysts were unaware of the correct procedures for handling electronic data. Training records were missing, outdated, or incomplete, and no process existed to verify training effectiveness. The quality unit had delegated training oversight without adequate follow-up, leading to repeated errors in data review and documentation.
In both cases, the root cause was educational. Employees had not been provided the foundational knowledge needed to carry out their responsibilities under GMP and 21 CFR Part 11. The result was noncompliance that could have been avoided through a structured, documented, and verifiable training program.
When training systems fail, the consequences ripple across the organisation. At the operational level, untrained or under-trained personnel may make errors that compromise product quality or data reliability. These can include incorrect equipment use, inaccurate record entries, or failure to follow critical process steps. Inadequate understanding of electronic systems can also lead to more serious violations, such as improper use of electronic signatures or the unintentional alteration of audit trails.
From a regulatory standpoint, such errors quickly escalate. The FDA views training as a key indicator of an organisation’s overall state of control. When inspectors encounter incomplete or inconsistent training records, it raises questions about the effectiveness of the entire quality management system.
Beyond citations, the consequences of poor training can include delays in product release, import alerts, remediation costs, and significant reputational damage. Moreover, organisations that cannot demonstrate traceable, role-specific training during inspections face credibility challenges. Without documented proof of competency, even compliant operations appear weak under regulatory scrutiny.
A robust training system, on the other hand, provides measurable assurance that personnel understand their tasks, know the applicable regulations, and can apply them consistently. For companies operating in data-driven, highly regulated environments, this assurance is indispensable.
For teams managing electronic systems, digital signatures, and data-driven processes, targeted training on 21 CFR Part 11 is essential. A practical and accredited way to meet this requirement is through the Introduction to FDA 21 CFR Part 11 Online Course offered by GxP-Training.
This one-hour, self-paced online course provides professionals with a clear understanding of the FDA’s requirements for electronic records and electronic signatures. It is CPD/CEU accredited and leads to a dated, traceable certificate that is fully compliant with 21 CFR Part 11. Certificates can be verified online or shared on LinkedIn, offering transparent proof of competency.
By incorporating this course into a corporate training program, organisations can build foundational understanding across departments and reduce the likelihood of training-related citations. The content translates regulatory text into practical guidance, helping staff recognise how system controls, audit trails, and digital signatures function in day-to-day operations.
To prevent training-related findings, organisations should view training not as a one-time activity, but as a continuous compliance process. The most effective programs integrate training into every stage of operations, from onboarding to ongoing performance monitoring.
A strong training framework includes a defined training matrix that maps regulatory and procedural training requirements to specific job functions. Each employee’s file should demonstrate that required training was completed, evaluated, and periodically refreshed. Supervisors and quality representatives should routinely verify that training records remain current and aligned with any procedural or system changes.
Equally important is the concept of training effectiveness. Passing an online module or signing a training log does not necessarily prove competence. Organisations must adopt mechanisms, such as post-training assessments, observed practice, or practical demonstrations, to verify that employees can apply what they have learned.
Integrating training into change control and CAPA processes is another hallmark of a mature quality system. Whenever procedures, systems, or equipment are updated, associated training requirements must be reviewed and updated accordingly. Training records should clearly indicate the revision or system version that each training session covers.
By embedding training into the quality system in this way, companies demonstrate a proactive approach to compliance. It shows regulators that the organisation not only reacts to findings but anticipates and mitigates potential gaps through structured, evidence-based education.
FDA warning letters consistently illustrate that under-trained personnel are a recurring weakness across the life sciences industry. The pattern is unmistakable: when employees lack the necessary knowledge or oversight, errors multiply, data integrity suffers, and compliance breaks down.
For quality professionals, the message is straightforward. Training is not an optional activity or an HR responsibility, it is a regulatory requirement under both GMP and 21 CFR Part 11. Building a structured, accredited, and verifiable training system is one of the most effective defences against inspection findings.
Courses such as the Introduction to FDA 21 CFR Part 11 Online Course provide a reliable foundation for staff across functions. They promote consistency, accountability, and regulatory awareness, all essential components of a compliant quality culture.
By strengthening your organisation’s training framework today, you not only reduce the likelihood of future citations but also build a culture of competence and ownership that supports long-term compliance success.
