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Train the whole team before the next inspection

Seat licences for the department or the site, a manager view of progress and results, and completion records exported for the training matrix. Hosted on The GMP Training Academy.

Run the numbers

Against the classroom course you were quoted

Budget holders compare on total cost, not list price. This does the comparison honestly, including the time your people spend away from the line.

Compare with the classroom course you were quoted

Enter your numbers. Nothing is stored. Time off site is counted for both options, and the online course is charged at its 2.5 hours of study, not zero.

Classroom fees (12 × €1,400)
€16,800
Classroom time off site (12 × 2 d × €450)
€10,800
Classroom total
€27,600
Online seats (12 × €0, 5 to 19 seats, 15% off)
Enter a budget
Online study time (2.5 h each)
€1,800
Online total
Enter a budget

You keep

€25,800

and nobody leaves the site for two days before the inspection.

Why training is the best line in the quality budget

Trained people make fewer defects, close faster and stay.

Regulators treat training as part of the quality system, not a favour to staff: EU GMP Chapter 2 requires it, requires its effectiveness to be assessed, and requires the records to prove it. The evidence says the same thing in numbers. Below: what the published studies found, what it looks like on your PQR KPIs, and the clause behind it.

  • 41%

    fewer quality defects

    in the most engaged teams compared with the least engaged, across 112,000 business units. Engagement and development opportunities are measured together. [1]

  • 26%

    greater ability to deliver quality products

    in organisations with a strong learning culture compared with those without. [2]

  • 37%

    higher employee productivity

    in the same strong-learning-culture organisations; output per person, not hours. [2]

  • 94%

    would stay longer

    of employees, at a company that invests in their learning. Retention is the quality metric nobody puts on the dashboard. [3]

The PQR KPIs a trained team moves

These are the numbers a QA head reports at management review and an inspector asks for when the PQR schedule comes up. No invented percentages here: measure yours over one review cycle before and one after, and you will have your own.

EU GMP Chapter 2 (2.10 to 2.13): all personnel whose activities could affect product quality receive training, its practical effectiveness is periodically assessed, and the programme is approved by the head of Production or Quality Control as appropriate. Training records are kept. ICH Q10 section 2.4 lists training among the resources senior management must provide for the quality system. [4]
  1. 01

    PQRs completed on schedule

    Measured as: % of reviews approved by the due date in the annual schedule

    Higher is better

    Authors who know what each section needs collect the data through the year instead of in the last month. The review is written on time and the schedule stops slipping product by product.

  2. 02

    PQRs with a trend evaluation

    Measured as: % of reviews that evaluate trends, not just tabulate results

    Higher is better

    Chapter 1.10 asks for a review that verifies consistency and highlights trends. Trained authors plot, compare with the previous period and say what the data means, which is what an inspector reads first.

  3. 03

    Conclusions that resulted in an action

    Measured as: % of reviews with at least one CAPA or change control raised

    Higher is better

    A review that finds nothing is rarely believed. Authors who interrogate the data find the drift, the recurring deviation or the supplier issue, and the conclusion becomes a record with an owner.

  4. 04

    PQR actions closed by the next review

    Measured as: % of previous-period actions verified closed

    Higher is better

    Chapter 1.11 requires the previous actions to be assessed. Actions written with an owner, a date and a measurable outcome get closed; vague ones roll over year after year and turn into a finding.

  5. 05

    CMO PQRs evaluated by the MAH on time

    Measured as: % of contract-manufactured products with a documented MAH evaluation

    Higher is better

    Chapter 1.10 places the evaluation with the MAH regardless of who writes the review. Trained MAH staff know what to check, what to challenge and how to record it under the technical agreement.

  6. 06

    QP referrals arising from the PQR

    Measured as: count per year of issues escalated to the QP from the review

    Higher is better

    A review that reaches the QP with a clear conclusion supports certification under Annex 16. More referrals early means fewer surprises at batch release and fewer retrospective investigations.

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Sources
  1. [1]Gallup (2020). The Relationship Between Engagement at Work and Organizational Outcomes: Q12 Meta-Analysis, 10th edition. 112,312 business units in 96 countries. Top-quartile business units on engagement showed 41% fewer quality defects, 81% lower absenteeism and 18% to 43% lower turnover than bottom-quartile units. Cross-industry meta-analysis. Gallup's engagement measure includes development and learning opportunities.
  2. [2]Bersin and Associates (2010). High-Impact Learning Culture: The 40 Best Practices for Creating an Empowered Enterprise. Organisations with a strong learning culture were 26% more able to deliver quality products, showed 37% greater employee productivity and were 46% more likely to be first to market. Cross-industry survey of about 40,000 organisations.
  3. [3]LinkedIn Learning (2018). Workplace Learning Report: The Rise and Responsibility of Talent Development in the New Labor Market. 94% of employees would stay longer at a company that invested in their career development. Cross-industry employee survey.
  4. [4]EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice, Part I, Chapter 2: Personnel (2013), paragraphs 2.10 to 2.13. ICH Q10 Pharmaceutical Quality System (2008), section 2.4 Resource management. The regulatory requirement for training and for assessing its effectiveness.
What a team licence includes

Seats, oversight, records

  • One seat per learner, assigned by the manager, transferable before first login
  • Manager view: progress, assessment results by module, certificates issued
  • Completion export (CSV) formatted for the training matrix
  • Certificates with verifiable IDs an auditor can check
  • Content mapped to your SOP numbers on request
  • Optional live Q&A session with the course author for the team
Volume pricing

Per seat, by tier

1 to 4 seatsList priceOn launch
5 to 19 seats15% offOn launch
20 to 49 seats25% offOn launch
50 seats and above35% offOn launch

The discount tiers are fixed. The launch price is announced to the waitlist first.

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