What is Good Training Practice?

While not a formal regulatory term, Good Training Practice (GTrP) is emerging as a shorthand in quality-focused organisations for a robust, evidence-based approach to training management. Here’s why you should be adopting a digital GTrP framework in your med-tech company.

Whether you’re developing medical devices, running clinical trials, or manufacturing pharmaceuticals, your team’s competence underpins your whole business plan. If your people aren’t trained - and you can’t prove they’re trained - you may not be compliant with key standards and regulations. That’s why every life-science business needs a model for Good Training Practice

While Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) are well established in the life-science sector, Good Training Practice (GTrP) isn’t formally defined in any of the regulation.

And yet failing to implement scalable procedures for training your teams (and documenting that process) can be just as damaging as breaching GMP or GCP.

What is Good Training Practice in the med tech sector?

Good Training Practice (GTrP) may not be formally defined in any med-tech regulation. But there are a key set of principles that govern training management across the major regulatory frameworks used in the US and the EU. 

In this blog post we’ve identified the central pillars of a training approach that can help you achieve compliance across a range of life-science standards and regulatory regimes.

Why you need a model for GTrP

There's no shortage of regulation and guidance pointing to the critical need for effective training across the life science sector. Key frameworks for compliance include:

• ISO 13485:2016, Clause 6.2
• FDA QMSR
• EU MDR and IVDR, Article 10
• ICH GCP E6 (R2)
• Annex 11 and  21 CFR Part 11 for electronic records and systems

These standards and regulations all require that you define training needs, document your training process, and prove that training has been carried out accordingly.

Specifically, they mandate that:

• Personnel are trained and qualified to do their jobs
• Training is effectively documented
• Comprehension is demonstrated
• Training is updated when SOPs and regulations change
• Proof of training is maintained and recorded in a standardised and unforgeable way
• Systems managing training data are validated, secure, and audit-ready

What happens without a training framework?

In the regulator’s eyes, if training isn’t traceable, repeatable, and provably effective - then it didn’t happen.

Because without a structured, risk-based approach to training management, you are missing a vital mechanism for controlling quality outcomes.

When you can’t control your training process you risk:

• Inconsistent onboarding
• Incorrect use of equipment
• Incorrectly maintained and calibrated equipment
• Use of outdated procedures

The bottom line is, without these training controls in place you risk product failure and patient safety.

With this in mind, Cognidox has suggested a scalable model for GTrP grounded in what regulators expect and what lean, compliant organisations need.

The 6 Pillars of Good Training Practice (GTrP)

1. Define training by role

Every role in your organisation must have a clearly defined training requirement.

As the FDA puts it:

"Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities… As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs."

Source: U.S. FDA Code of Federal Regulations Title 21, Part 820.25(b)

To build this pillar, start with a training needs analysis that maps procedures, policies, and regulatory expectations to each job function.

Then define the documented training requirements for each job role, detailing the specific documents and videos to consume, tests to complete, and any necessary external certificates to upload.

These requirements should then serve as the definitive blueprint for ongoing competency management and compliance verification. This ensures onboarding will always be targeted, retraining is relevant, and no one falls through the cracks.

Role-based training simplifies audits. When asked “how do you know your people are competent?”, you can show exactly what each role requires - and who meets the mark.

2. Keep it current

Training content and materials should always align with the latest regulations and your approved standard operating procedures (SOPs).

This pillar focuses on ensuring the accuracy and validity of the information being taught. If an SOP, policy, or regulation is updated, the related training module must be updated to reflect the correct, current information.

Training on outdated documents is a major red flag.

3. Track everything

Good training records are more than a ticked box. You need to be able see:

• Who was trained
• What they were trained on
• When it happened
• How it was assessed
• Who authorised it

These records must be secure, searchable, time-stamped, and tamper-proof, with full audit trails. That’s what Annex 11 and 21 CFR Part 11 expect - and what you’ll be asked to produce at inspection.

You need the digital tools integrated within your training system to meet these specific document control requirements.

4. Train when things change

A change to a controlled document, process, or system should automatically trigger retraining for affected roles.

This is where GTrP meets change control. You’re not just updating a document - you’re updating people’s understanding. And that’s what the FDA and notified bodies want to see.

5. Test comprehension 

Training without comprehension is not enough.

Whether it’s through quizzes, third-party assessments, supervisor reviews, or formal tests - your system needs a way to demonstrate effectiveness. Not just that someone clicked through a module, but that they understood it.

But ISO 13485:2016 is also clear:

“The method used to check effectiveness should be proportionate to the risk associated with the work.”

That means you might use simple quizzes for low-risk tasks - and robust assessments for high-risk roles.

6. Make it part of your QMS

Training shouldn’t sit in isolation from the rest of your compliance efforts. It should be fully integrated into your quality management system.

That means:

• Linked to document control
• Governed by change management
• Subject to regular review
• Managed with the same rigour as CAPA, audits, or risk

Training can’t be an afterthought—it’s the connective tissue that makes your QMS work.

Good Training Practice is foundational

In a life science business, training is not just about knowledge transfer. It’s about:

Proving compliance
Reducing risk
Enabling scale
Improving audit outcomes
Supporting safe, effective product development

Good Training Practice ensures that training isn’t just delivered - it’s documented, validated, and embedded.