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Practical GMP in Cleanrooms ‐ Level 1

What happens when I order?

Price: 1 490 SEK excl. VAT

Duration: appr. 90 minutes

Price: 6 705 SEK excl. VAT

Duration: appr. 90 minutes

Save: 745 SEK excl. VAT

Cleanroom Training Course - Online 

”Practical GMP in Cleanrooms - Level 1” is an Online training course that is carried out directly in a browser and provides a personal course certificate after course completion.

Course material is included with slides and glossary (PDF file to download) that serves as support during the course.

 

NOTE: ENGLISH VERSION (No subtitles are available)

Looking for our Swedish version? Click here

Course objective

The objective of the course is to create a better understanding of what GMP, Good Manufacturing Practice, is and why GMP is used in cleanrooms. The course is intended as an introduction to GMP and cleanrooms, but can also be used as part of the annual GMP update.

 

Course target group

All personal categories in need of GMP and cleanroom knowledge, regardless if these have cleanroom experience or not. This includes Personnel working in cleanrooms, i.e. operators, supervisors, cleaning personnel, service and maintenance personnel, environmental monitoring personnel, QC, or others who want to learn more about GMP and cleanrooms.

 

Course content

The course consists of 6 Parts, with multiple-choice questions after each Part. The course discusses Cleanrooms, Contaminants, GMP - Good Manufacturing Practice, Cleanroom according to GMP, Sampling and analyses, and finally Humans in the cleanroom. 

Course length

The total course length is approximately 90  minutes, consisting of 62 minutes video modules (Parts), followed by multiple-choice questions after each Part, and finally a short survey.

Payment and time to assign/complete the course

You pay for the course license(s)* with card**, and you get access to the course license(s) directly after approved payment. You have 90 days to assign the course license(s) to the course participant(s) (or yourself), after which the course participant(s) has/have 90 days to complete the course. The courses are exclusively sold to legal entities - please see our Terms and conditions, and FAQ for more information.

Do you wish to pay by invoice?

Please contact us at sales@mcleaned.com for more information. 

 

* 1 course license per course participant and course
** VISA with Verified by VISA, or MasterCard with MasterCard SecureCode

 

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Course Content


 

1. Cleanrooms

  • What is a cleanroom and how does it work?
  • Why are cleanrooms used within GMP?
  • Who uses cleanrooms?

14min

2. Contaminants

  • What are the contaminants
  • Which contaminants affect GMP activities?
  • Microorganisms and microbiological cleanliness
     

9min

3. GMP - Good Manufacturing Practice

  • General workflow - GMP
  • Instructions and routines
  • Documentation and deviations
  • Sampling
  • Assessment and release

7min

4. Cleanrooms according to GMP

  • Eudralex, Volume 4, Annex 1
  • Cleanrooms in pharmaceutical manufacture
  • The cleanliness Grades A, B, C, and D
  • Limit values - Particles and microorganisms

9min

4. Sampling and analyses

  • Particle concentration in air
  • Determination of microbiological contaminants
  • Sampling microorganisms in air
  • Sampling microorganisms on surfaces
  • Sampling microorganisms on gloves
 11min

4. Humans in the cleanroom

  • Contaminants from people
  • What is allowed and not allowed in cleanrooms
  • Personal hygiene - Personnel hygiene
 13min