Safety and compliance in the GMP cleanroom: avoid risks, ensure quality

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Safety and compliance in the GMP cleanroom

For pharmaceutical production operators

Practical, process-oriented, tailor-made - the exact requirements and objective of the learning journey are defined in advance and the curriculum and duration are individually adapted to your needs.

The training module takes place at your location. Your employees do not have to travel, you save working time and costs. Your production continues unhindered. Alternatively, we can invite you to one of our training centers, including a clean room.

Mindset and skillset for key moments in the cleanroom are sharpened.

Examples of key moments and learning objectives:

  • Learners gain a deeper understanding of the essence of Good Manufacturing Practice (GMP) and the Contamination Control Strategy CCS
  • They internalize the purpose of zone concepts and learn how to apply important principles in practice when placing materials
  • You understand the principles for dressing appropriately and train intensively to implement them
  • You will learn effective procedures for avoiding contamination in non-sterile cleanroom areas (GMP classes D and C)
  • Impressive visualizations allow learners to understand the background to rules and motivate them to implement them
  • Essential knowledge about cleaning and disinfection is imparted and the application of measures based on the SOPs is trained hands-on

We work with you in advance in a process analysis workshop to develop a detailed selection of focal points and clear objectives. This coordination and a focused curriculum ensure that the learning solution reinforces the voice of your quality assurance and internal trainers.

Background

Manufacturers of pharmaceuticals and operators of microbiologically controlled cleanrooms are faced with the challenge of maintaining the highest level of awareness of appropriate behavior in everyday working life. In addition to the special requirements for sterile pharmaceuticals, this also applies to non-sterile products such as certain solutions, creams, ointments, intermediate products with low biological contamination and implants.

Manufacture of sterile drugs?

Take a look at the program Excellence in aseptic handling in sterile production and filling.

We are here for you

For your individual solution, talk to one of our developers for learning solutions without obligation.
You can reach us at +43 4242 44075 and ausbildung@comprei.eu

Request directly

Information about the program

  • Intensive exchange in small groups (max. 12 participants)
  • Supervision by two comprei learning guides
  • Exclusive in-house implementation (in-house)
  • The learning service complies with the ISO 21001:2018 and ISO 29993:2018 standards
  • Please contact us for a customized offer.
  • Due to the individual adaptation of the curriculum to your processes and learning objectives, this training program can only be carried out on a customer-specific basis.

The participation fees are due within 10 days of receipt of the invoice. The following fees apply if participation is canceled:

  • No fee up to 28 calendar days before the start of the event
  • Up to 1 week before the start of the course 50 % of the participation fee
  • Within 1 week before the start of the training 100% of the participation fee

You can find the full GTCs here: www.comprei.eu/agb

FAQ

Yes.

We offer this training directly at your location on the date of your choice. In-house training ensures maximum flexibility and training that takes place where it will later be used.

For detailed information on in-house training, please contact us. 

Yes.

In the event of cancellation by the participant, the following fees will be charged: up to 28 calendar days before the start of the event no fee, up to 7 calendar days before the start of the event 50% of the participation fee, less than 7 calendar days before the start of the event the full participation fee.

This module is suitable for both new and experienced employees. For detailed customization to your target groups, contact our learning solutions developers at ausbildung@comprei.eu

  • The mobile cleanroom cuboid is a demountable and transportable cleanroom cabin specially developed for in-house training.
  • By simulating all the processes within this cleanroom and the direct influence that every activity has on it, awareness is raised through experience and thus firmly anchored.
  • The cleanroom cuboid is so compact that it usually fits into an ordinary seminar room.
Learning solutions for the pharmaceutical industry, GMP

Clean room cuboid

Realistic simulations and visualizations of activities make invisible connections visible. Learners experience their own impact in the cleanroom right in the middle of the action. They experience in-depth sensitization that becomes firmly anchored.