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Practical GMP in Cleanrooms ‐ Level 2

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Price: 199 EUR excl. VAT

Duration: Approx. 100 min

Price: 896 EUR excl. VAT

Duration: Approx. 100 min

Save: 100 EUR excl. VAT

Cleanroom Training Course - Online 

”Practical GMP in Cleanrooms - Level 2” is an on-demand Online training course that 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.

This course is created by Prof. Matts Ramstorp together with Johan Ramstorp

NOTE: ENGLISH VERSION (No subtitles are available)

Looking for our Swedish version? Click here

Course objective

”Practical GMP in Cleanrooms - Level 2” is intended to be used as part of the annual training for everyone working in connection with GMP and cleanrooms. The purpose of the course is to provide more in-depth knowledge of how the European GMP (Good Manufacturing Practice) affects practical work in a cleanroom, especially during the manufacture of various types of sterile pharmaceutical products.

Course target group

The course is aimed at personnel with previous experience of cleanrooms and cleanroom work within GMP operations, or who have completed the course ”Practical GMP in Cleanrooms - Level 1”. The course is primarily suitable for operators, supervisors, cleaning personnel, service- and maintenance personnel, as well as personnel engaged in environmental monitoring.

Course content

The course consists of 6 Parts, with multiple-choice questions after each Part. 
This course is a direct continuation of  “Practical GMP in Cleanrooms – Level 1” and cover sterile medicinal products manufacturing. Both manufacturing principles, i.e. terminal sterilisation and aseptic manufacturing, are described together with the different types of clean air devices (clean zones) used in this context. Finally the advantages as well as disadvantages of the different types of clean zones are addressed together with what is considered good practice when working in clean zones.

Course length

The total course length is approximately 100 minutes, consisting of 74 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** or request to pay by invoice***.

You get access to the course license(s) directly after approved payment and 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 additional 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.

Questions?

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

Don't forget to have a look at our other courses
> See all Courses

 

* 1 course license per course participant and course
** VISA with Verified by VISA, or MasterCard with MasterCard SecureCode
*** If approved you will receive an Offer and more information via email

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Download specifications (PDF)

Course Content


 

1. Introduction – Cleanrooms and GMP

  • What are the different GMP grades
    and what differentiates them?
  • What are the different GMP grades
    used for?

11min

2. Cleanliness demands according to GMP

  • Particles and viable microorganisms
    in Annex 1
  • Annex 1 versus ISO 14644 - 1
  • Microbiological cleanliness
    requirements according to Annex 1
     

15min

3. Sterile products – Terminal sterilisation

  • What is terminal sterilisation,
    and when is it used?
  • Diagrammatic summary of
    terminal sterilisation

9min

4. Sterile products – Aseptic manufacturing

  • What is Aseptic handling,
    and when is it used?
    Diagrammatic summary of
  • Aseptic Manufacturing

10min

5. Clean Zones

  • Why are clean zones used?
  • Clean zones to protect products
  • Clean zones to protect personnel
  • Isolators
  • RABS
    (Restricted Access Barrier System)
     
 17min

6. Working in Clean Zones

  • The function of the different clean zones
  • Procedures in clean zones
  • Things to consider when working in
    clean zones
 12min