You will learn to interpret regulatory requirements regarding cleanroom classification and work according to these requirements as well as classifications in compliance with GMP (Good Manufacturing Practice). You will also understand SOPs (Standard Operating Procedures) and learn how to apply them in relation to GMP.
Cource Content
- Classifications in relation to GMP
- Understanding and using SOPs
- Sterile gowning and correct procedure for entering through the airlock into the cleanroom
- Risks, particles, and microorganisms in cleanrooms and disinfection
- Chemistry and methods for using the correct cleaning agents, disinfectants, dosages, work methods, and work sequences
- The importance of following a cleaning plan, documenting in practice, and using logbooks
- Understanding the importance of personal hygiene
Target Group
The training is primarily aimed at employees who work with cleanroom cleaning or wish to pursue employment in this area.Certificate
You will receive an AMU competence certificate upon passing the exam on the final day of the course.
3 Good Reasons to Take This Course
- Understand Cleanroom Requirements: Learn about regulatory requirements and cleanroom classifications, and how to work according to GMP rules. You will be trained in the correct use of SOPs, which are essential for safe and efficient operations.
- Become an Expert in Cleaning Methods: The course provides knowledge about cleaning agents, disinfection methods, and work processes to ensure the cleanroom remains free of particles and bacteria. You will also learn to follow cleaning plans and document correctly.
- Ensure Hygiene and Quality in Your Work: Understand how personal hygiene and proper use of sterile clothing are crucial to minimizing contamination risks, and how to carry out cleaning tasks according to the highest standards.
Take the course and master cleanroom cleaning and procedures – sign up today!
22659 - Rengøring i renrum, metoder og procedurer
Beskrivelse: Efter endt uddannelse har deltageren kendskab til myndighedskrav for god fremstillingspraksis for fremstilling af sterile lægemidler (EU GMP, Annex 1) i forhold til rengøring i renrum og forståelse for klassificering af renrum og kendskab til generel mikrobiologi og forståelse for vigtigheden af kontrol af kontaminering med mikroorganismer og partikler, og hvilken rolle rengøring, adfærd og hygiejne spiller.Deltageren har forståelse for vigtigheden af god hygiejne og adfærd indenfor GMP, herunder håndvask og omklædning til sterildragt, og kan iklæde sig en sterildragt og efterleve god hygiejne og adfærd under rengøring i renrum og viden om forskellige rengørings- og desinfektionsmidler og deres effektivitet, og kan planlægge og udføre korrekt rengøring mht. dosering, arbejdsmetoder og rækkefølge afhængig af klassificering af renrum.Deltageren har også forståelse for vigtigheden af dokumentation og registrering af rengøring i henhold til GMP-krav. Deltageren kender dermed til opbygning af rengøringsplaner og SOPer, kan anvende logbøger og dokumentere efter god dokumentationspraksis.
Fagnummer:
22659 Rengøring i renrum, metoder og procedurer
Varighed
3 dage
Inden for AMUs målgruppe:
DKK 642,00
Uden for AMUs målgruppe:
DKK 2.266,40