Are You Confident in Your Training Records? Auditors Will Be.

Imagine this: An auditor, or an FDA inspector, walks into your facility, skips past the shiny validation protocols, hygiene logs, and data integrity reports, and asks for one thing – training records. Not just for your employees but also for your third-party consultants. Can you confidently hand them over? Or will you scramble to piece together documentation that should have been ready yesterday?

In the pharmaceutical industry, training is not just a checkbox – it’s a regulatory mandate. Yet, many companies focus so intensely on other compliance areas that they overlook the fundamental requirement of ensuring everyone involved in their operations is adequately trained. This includes consultants, whose training records are often left unnoticed. Let’s get specific: 21 CFR 211.25(a) from the FDA explicitly states that all employees and consultants (211.34) must have education, training, and experience to perform their assigned duties as well, trainings must be continuous to meet current Good Manufacturing Practices (CGMPs). Meanwhile, EU GMP Annex 11 requires that all personnel using computerized systems in GMP-regulated activities be appropriately trained and qualified.

So, here’s the provocative question. Do you know if the people you’ve hired – whether employees or external consultants – are properly trained and certified?

Form 483, Warning Letter

Between the fiscal year 2024 to 2025 (remind you that we are still living in 2025), the FDA issued 49 citations for violations of 21 CFR 211.25(a), highlighting a critical issue: inadequate training of personnel involved in drug manufacturing. These citations often included descriptions like, “GMP training is not conducted on a continuing basis” or “Employees are not given training in current good manufacturing practices”[1].

When companies are flagged for these violations, they typically propose corrective actions to ensure adequate training. However, if the FDA finds these plans unsatisfactory, a Warning Letter is issued. Almost every Warning Letter citing 21 CFR 211.25(a) includes a recommendation to engage a qualified consultant under 21 CFR 211.34.

Let’s consider Kaylaan LLC as an example. In January 2024, an FDA inspection led to a Form 483 citing inadequate training practices under 21 CFR 211.25(a). Months later, after finding Kaylaan’s response rather unsatisfactory, the FDA issued a Warning Letter in August[2], stressing the need for corrective actions with a header, “CGMP Consultant Recommended”. This case shows the FDA’s emphasis on both proper employee training and the use of qualified consultants to rectify compliance deficiencies.

Why Hire GxP-CC?

When faced with an FDA Warning Letter recommending a CGMP Consultant, ensuring you hire the right expert is essential. The FDA explicitly points to 21 CFR 211.34, which requires consultants to possess sufficient education, training, and, and experience to advise on the subject for which they are retained. At GxP-CC, we know firsthand how daunting it can be to navigate compliance in a highly regulated industry – especially when you’re unsure where to start, how to structure an effective program, or how to measure its impact. It’s even more overwhelming when your Warning Letter points out your shortcomings, leaving you under intense pressure to perfect training all at once.

After more than a decade of refining our approach through real world trial and error, we’ve developed robust, ISO 9001-certified training programs (certified by DQS) that set the standard for onboarding and continuous education. Our structured four-week foundation program, scenario-based workshops, interactive micromodule e-learnings, and certification exams ensure every one of our consultants is not only highly qualified and up to date, but also fully prepared to deliver training themselves. We don’t just train our consultants to excel – we equip them to train your teams, too. Our comprehensive train-the-trainer programs empower organizations to independently uphold high standards of compliance and foster a strong quality culture from within.

Whether you are starting from scratch or looking to elevate your team’s expertise in areas like audit trail compliance, data integrity, or AI/ML in GMP environments (check out our previous webinar series and be sure to subscribe to our newsletters!), our team is committed to guiding you every step of the way – because we know what it takes to achieve and sustain excellence in this industry.

When the FDA says “CGMP Consultant Recommended”, don’t settle for less than the best. Contact us today to learn how GxP-CC can tailor solutions to your specific needs.

References:

[1] https://datadashboard.fda.gov/cder/cd/inspections.htm

[2] https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kaylaan-llc-681977-08192024