Systematic Training Gap #1: Quality Leadership and Culture
Our analysis identified quality leadership and culture as a foundational systemic gap. When senior management does not give the quality unit sufficient authority, resources, and organizational support, deficiencies rarely stay confined to one procedure or department. They can affect investigations, facility maintenance, production decisions, corrective and preventive action (CAPA) effectiveness, and timely risk escalation throughout the pharmaceutical quality system (PQS).
What the Warning Letters Revealed
The Warning Letters reviewed for this analysis repeatedly showed three related patterns: ineffective quality-unit oversight, inadequate management attention to known deficiencies, and corrective actions that addressed individual observations without resolving their underlying systemic causes.
1. Ineffective Quality Unit Authority
Quality units (QUs) commonly exist on paper but often lack the authority, resources, or competence to enforce current good manufacturing practice (cGMP) compliance. These limitations lead to a host of issues, from failing to investigate discrepancies to allowing unsafe production practices to continue.
For example, in a June 2026 Warning Letter, the FDA found that Excelvision, a Fareva facility, was disinfecting critical equipment components with sporicide rather than sterilizing them between batches. The pharmaceutical manufacturer responded by stating that some components cannot be sterilized due to machine design.
The company also claimed they would use sporicide between each batch, increase microbiological sampling, and swab equipment, but the FDA deemed these actions unacceptable substitutes for sterilization. FDA concluded that Excelvision's QU either lacked the proper authority to carry out its responsibilities or had insufficiently implemented them. The company must develop a remediation plan to ensure its QU has the authority and resources to function effectively, among other requirements.
2. Inadequate Executive Oversight and Resourcing
Warning Letters commonly point to senior leaders failing to resolve deficiencies and systemic flaws, rather than exercising the oversight that cGMP compliance requires. Without that oversight, employees may find workarounds or hide issues that executive leadership failed to address proactively. Some leaders do not give QU the funds to ensure maintenance programs are followed, compromising product safety and ultimately forcing large-scale remediation or heightened scrutiny.
Consider the June 2026 Warning Letter issued to Huons Co., Ltd. FDA found that a microbiology team leader directed staff to discard bioburden plates that showed contamination, and changed timestamps to create backdated documentation. The team leader also admitted to cutting pages out of a logbook and replacing them with fabricated ones, instructing an analyst to backdate and omit bioburden testing results.
Huons must conduct a comprehensive investigation into the scope of the falsification, perform a risk assessment of the quality of the affected drugs, and commit to two years of third-party audits to verify its corrective actions, among other requirements, to address the violations.
In the Warning Letter to Excelvision, the FDA found that the company had built parts of its sterile manufacturing areas, including filling rooms and compounding rooms, with ceiling and partition materials that could not be waterproofed or decontaminated. The facility experienced repeated water intrusion, and mold was detected in cleanrooms. Now the company must implement a CAPA plan ensuring vigilant oversight of equipment and facility conditions, including making necessary repairs and upgrades.
3. Reactive CAPAs and Repeated Deficiencies
Throughout our research, we concluded that leadership may view recurring problems as isolated incidents that can be fixed by superficial corrective and preventive action (CAPA). Companies commonly retrain employees rather than finding and fixing the root cause. For example, in a December 2025 Warning Letter to Apothecary Pharma, LLC, the FDA found that retraining on aseptic technique failed to address specific behaviors that had caused the original contamination risk. Putting a temporary “band-aid” over problems may keep production moving, but it won't prevent recurring deficiencies.
A superficial approach to problem-solving can also go along with reactive compliance, where companies act only after regulators intervene. In both the Excelvision and Huons Warning Letters, for instance, the FDA recommended a voluntary recall before either company committed to one, rather than deciding to recall on their own as a proactive measure.
Why This Is a Systemic PQS Weakness
Leadership is a foundational component of a PQS because it establishes the training, resources, policies, responsibilities, and conditions for an effective quality culture. When there are major flaws in leadership, it ripples throughout the entire PQS and persists until the underlying problems are addressed.
In our review of FDA Warning Letters, these factors consistently emerge as systemic PQS weaknesses:
- Misaligned culture and incentives: There is a disconnect between documented policies and the actual operating culture. When known deficiencies go unresolved for extended periods, it can signal to employees that quality concerns aren't the priority, regardless of what a written policy says.
- Siloed quality responsibilities: The letters we reviewed suggest that quality was treated mainly as the QU's job, with little evidence that leadership extended that responsibility elsewhere. To build a culture that supports compliance and prioritizes patient safety, quality must be integrated across all departments and owned by everyone, from executive leaders to frontline operators.
- Little incentive to report concerns: When leaders treat quality as an operational inconvenience, employees may have little incentive to raise concerns rather than work around them. Unless leaders encourage and reward proactive, compliance-driven behavior, it's hard to build a culture where workers feel comfortable flagging problems before they escalate.
What This Means for Training
A strong quality culture can't be built with an annual PowerPoint presentation or generic training modules. Nor will training lead to actual changes if real-world operating conditions stay the same and leaders continue to incentivize speed or volume over quality. A company might train staff on root-cause analysis, for example, while still rewarding them for closing investigations quickly. This behavior sends the message that training is meant to check a box and does not change how people work.
To close the gaps revealed by FDA Warning Letters, training must focus on practical decision-making rather than memorizing regulatory summaries. Leaders and QU staff need opportunities to practice evaluating risk in real-world scenarios. Ultimately, training should require them to demonstrate competence before making high-stakes decisions on the job.
Nonetheless, training alone isn't a cure-all. Even the best program will fall short without stronger governance, real authority for the quality unit, proper resourcing, and metrics that reward quality.
How Organizations Can Close the Gap
To build a training system that leads to real improvement and sustainable capability, organizations must first define their quality risks and determine what actions are required to mitigate them and who must be involved. For example, if your organization is at risk of inadequately investigating deviations, define what a good investigation looks like in practice. What specific data needs to be collected? Who is responsible for finding the root cause?
Once you map out the actions needed and people involved, you can tailor training to the tasks at hand. Training should include learning methods that allow employees to apply their skills, like making judgment calls through group discussions and practicing decision-making in workshops.
Lastly, you need a way to measure the effectiveness of cGMP-related training to determine employee competency. This may involve direct observation on the manufacturing floor or evaluating their decisions during simulated case studies.
Training Solutions
At The Center for Professional Innovation and Education (CfPIE), our Training Advisors are available to help you select the right courses, which are also customized to your organization's needs. Our courses can include real-world scenarios, case studies, and collaborative problem-solving so your team can practice making high-stakes decisions.
Courses that could be particularly helpful in addressing systemic issues include:
- Current Good Manufacturing Practices (cGMP) Training: Breaks down core GMP requirements using real-world examples, helping leaders understand the "why" behind the rules so they can make better decisions and build compliance into every process.
- Human Error Prevention (HEP): Equips leaders with strategies to identify root causes and prevent human errors.
- Effective Internal and External Quality Assurance Auditing: Teaches quality professionals how to lead thorough audits with confidence and connect the audits with their CAPA programs.
- FDA Inspections: What Regulators Expect and How to Prepare: Equips management with the practical strategies needed to conduct self-inspections, navigate FDA interactions, and properly respond to regulatory observations.
- GMP Auditor Training: Covers the steps involved in a successful site audit and how to collaborate with the audit team.
Consider our free one-hour training session on this topic for a low-commitment starting point to strengthen your leadership.
Build a Quality Culture With CfPIE
The recurring weaknesses identified in our review underscore the need for management accountability, clear authority within the quality unit, adequate resources, and timely action on quality risks. Training can strengthen the knowledge and judgment needed to fulfill these responsibilities, but sustainable improvement also requires changes to governance, operating conditions, and management oversight.
CfPIE offers courses and customized on-site training to help leaders and quality professionals deepen their understanding of cGMP requirements and apply that knowledge to practical decisions. Contact our Training Advisors or call 610-708-2264 to discuss training tailored to your organization’s quality-system priorities.
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