ELM-746 EudraLex – Volume 4 Annex 1: Sterile Processing and Technologies

From ground-breaking medical technologies to the medicines that we depend on every day, the safe manufacture of medical products depends on maintaining sterile processing conditions. This course will examine those practices and the guidelines for sterile manufacturing cleanroom classifications, aseptic processing techniques, and quality control measures outlined in EudraLex, Annex 1.

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CEU Credits: 0.1
Course Code: ELM-746
Duration: 20 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 03/05/2025

Curriculum for this course

An Irreplaceable Resource
Cleanrooms
Contamination Control Strategy (CCS)
The CSS and RIsk-Based Elevated Requirements
Risks and Cleanroom Grading
Check-In
Terminal Sterilization Methods
Aseptic Processing
Interventions and Stoppages
Sterile Filtration
Check-In
Aseptic Technologies
Sampling
Bioburden Monitoring and Parametric Release
Inspection
Container Closure Testing
Check-In
New Hope
Test your Knowledge!
v1.0 Course released on 04/29/2025

Author

Ian Nicholls

Director at Explic8

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