EU GMP Online Training | Pharmaceutical Employees

EU GMP Online Training | Pharmaceutical Employees

Do you have employees who need EU GMP training, including validation, record-keeping (GDocP) and GDP? Or perhaps you’re exploring current job opportunities and need to be sure you’re up to date?  Whether you’re starting-up an overseas production facility, or have a long-established production company for complementary medicines (CBD), common pharmaceuticals or new medical devices, you’ll need to ensure that you and your employees are meeting current EU GMP training requirements. 

So how can you make sure employees get certified, validated EU GMP training, without blowing your training budget? The answer is by using online GMP courses as part of your EU GMP training implementation plan.

This article covers options for online EU GMP training courses which can help you and your employees meet FDA, EU PIC/S, TGA, and related CGMP compliance requirements. Reading time: 2.5 minutes.

EU GMP and Compliance Audits

Many countries show diligence in relation to EU GMP and GDP audits.

Diligent GMP compliance monitoring means pharmaceutical manufacturers, veterinarian product producers and medical device companies are prone to frequent GMP audits and CAPA (continuous improvements, corrective actions and preventative measures to ensure product safety).

Although GMP audits are inconsistent from country to country, the World Health Organisation is demanding greater protections of vulnerable consumers, following large recalls of contaminated and substandard medicines.

The WHO’s initiative for higher regulatory standards means ensuring your employees have current training certificates in EU GMP, PIC/S and other relevant codes, is more important than ever to reduce your risks.

What is a GMP Audit?

A GMP audit is where a country’s designated regulatory agency (typically a Government agency such as the FDA, TGA or EU PIC/S Auditors) monitor compliance with cGMP, GDP and CAPA.

Areas of regulatory audits include, but are not limited to, sources, storage and handling of all ingredients (which are now subjected to increasing supply-chain reporting), sterility, hygiene and QA testing involved in all aspects of the manufacturing processes, validation compliance, safety testing, batch sampling/content analysis and distribution.

  • Because GMP and PIC/S is so specific for safety in pharmaceutical production, it’s easy to get caught out,
    • employee training slips and/or new processes and systems are added
  • When new contractors start work
  • Or when production procedures, technologies, calibration systems, data integration systems, workflows or equipment changes, but proper validation procedures aren’t followed as precisely as they should be.
  • Taking online training helps your employees keep GMP closely in mind as they go about their work days; and can help keep operations in compliance with ongoing training requirements.
  • It’s also beneficial for new learners (GMP orientation training) and returning workers (coming back to your production plant(s) after long service leaves, maternity leave, study leave time or sick leave, for example)
  • For help with a GMP Audit or EU GMP Audit, contact PharmOut.

Requirements: Employees must have current GMP / EU GMP and GDP training (cGMP)

Working in pharmaceutical production, other life science manufacturing businesses or medicinal cannabis extraction, you’ll need to ensure you, along with any employees you Supervise, have adequate GMP / EU GMP and GDP training. Training is necessary to maintain your production licence and GMP certifications, and has a direct impact on public safety.

Read the blog about the importance of GMP when it comes to substandard or counterfeit medicines.

What employers need to know about EU GMP?

  • In order to meet FDA, TGA or PIC/S training requirements for EU GMP / GMP, employees must complete validated training courses
  • Employers have a legal responsibility to provide initial GMP training as well as ongoing training, learning and development
  • Organisations must ensure ALL employees, working at any manufacturing or supply chain facility — including overseas facilities — are current in their EU GMP knowledge, and compliance
  • Although some countries have less auditing capacity (or diligence), the World Health Organisation is hoping to increase GMP / GDP compliance audits to better protect the vulnerable populations being given substandard or contaminated medications

Operational leaders must ensure that all employees who had EU GMP orientation training at the start of their employment, remain up to date with current GMP / PIC/s and more — this includes employees working in offshore facilities.

  • The biggest challenge facing organisations needing to ensure employees get quality EU GMP / GMP and GDP training, is the factor of TIME
  • Other factors employers must consider include:
    • EU GMP Training Costs / average annual training budgets for GMP training courses and conferences
    • Convenience and Course Scheduling (vs online course options)
    • Learner engagement with course content; impact on data retention
    • Follow through (compliance / GMP adherence) in production and distribution environments
    • Integrated record-keeping for employee compliance training

What’s the best way to train employees in current EU GMP?

  • Employees, Supervisors and new contractors tend to be exceptionally busy individuals inside and outside of shift hours
  • During a shift, there are also numerous procedures that need to be followed, with very little downtimes scheduled (due to labour cost pressures)

This means there are few — if any —

Ensure the legality, suitability and competence of the third party site (Contract Acceptor) to execute the contract.

Bullet 2:

Have the appropriate knowledge necessary to carry out the operations correctly in accordance with regulations and marketing authorization of the product.

Add bullet before bullet 3:

Monitor and review performance and identify need for improvements.

large blocks of time that could be readily allocated to training courses (nearby or onsite).

Outside of working hours, everyone also seems busy with family obligations, other educational pursuits, conference schedules, hobbies and the like….yet training must be a priority to meet regulations and minimise production risks.

So how do you get your employees trained in current GMP (current EU GMP) to meet current FDA, TGA and PIC/s requirements?

Solution: You blend it.  You blend onsite training with low-cost online GMP training courses to provide a blended, more convenient learning experience for your production, testing and distribution employees.

Instructor-led training should also be part of the blended learning experiences you can offer to new and existing employees. But online courses add that bit of flexibility that can make all the difference in the world to ensuring completion of training requirements and improving your employees’ understandings of current GMP requirements.

The benefit of providing digital training methods (online EU GMP courses) is that these courses can be done on the employee’s time frame. They can be completed at their own pace, even in unexpected down time. All without interrupting workflows or disrupting family time, such as might occur when an employee is forced to travel to an instructor-led GMP course.

Benefits: EU GMP eLearning can be accessed nearly anywhere in the world, at any time.

Your team can complete a course while waiting for a child to finish a tutoring appointment or sports lesson, for example. Or they can break up longer courses into separate days or weeks.

  • The employee can review the completed materials again for up to 12 months to further enhance retention and learning outcomes.
  • The validated online assessments can be done at any time, with immediate downloading and/or emailing of their Certificate(s) of Completion.
  • Best of all, training budgets can be met when these low-cost training methods are combined with other options, such as public GMP courses or instructor-led courses onsite at your facilities (and PharmOut offers GMP and EU GMP training, validation training and GDP training, anywhere in the world).

In response to the busy lives everyone leads these days, and the necessity of keeping your production lines running smoothly, safely and profitably; we recommend investigating the EU GMP / GMP e-learning and online Certificate Courses for your team.

Next article:

10 Ways to Cut your Training Costs for GMP and EU GMP employees

For instructor-led courses, visit PharmOut’s GMP, GDP, CAPA and EU GMP onsite training courses or public courses.