Aseptic manufacturing facilities (online training)
one day digital training on pharmaceutical facilities with focus on GMP requirements, design and validation.
This online training on aseptic manufacturing facilities starts with an introduction to basic concepts: cleanrooms, airlocks, HVAC, isolators and RABS.
Moving forward from the GMP regulations (US and EU) you learn what is required to build, validate and operate an aseptic manufacting facility. This training includes the requirements of the new Eudralex Volume 4 annex 1 published in August 2022.
Topics such as floor plan design, HVAC requirements (pressure, air changes, etc.), qualification of cleanrooms according to ISO 14644 are covered in detail.
Training contents
Part 1: introduction
You learn concepts such as cleanrooms, airlocks, HVAC, isolators and RABS.
Part 2: regulatory background
The second part of this online training provides an overview of the GMP regulations. You learn the detailed requirements regarding cleanrooms, HVAC, gowning, etc. from the EU and US regulations. This part includes the new requirements of Eudralex annex 1, and highlights the main differences from the previous version. You also learn where to find and how to retrieve information from the regulatory documents.
Part 3: intermezzo on contamination
Part 4: cleanrooms
In this part of the training you dig into the technical details on pharmaceutical cleanrooms, HVAC and facility design.
Part 5: cleanroom qualification
Before taking a cleanroom in use it must be qualified. You learn how to perform cleanroom qualification in accordance to ISO 14644 and Eudralex Volume 4 annex 1. This online training covers all cleanroom qualification tests required by the new Eudralex annex 1.
Part 6: operational controls
Part 6 of the training provides a high-level overview of operational aspects such as maintenance, cleaning and disinfection.
Part 7: barrier technology
In the last part of this training you get a proper introduction to isolator and barrier technology. This part also covers disinfection and transfer technologies such as VHP, dry heat, E-beam.
Practical information
Duration: 6 to 8 hours
Language: english
Format: digital online (self-paced)
Who this training is for
- project managers
- project engineers
- QA engineers
- validation engineers
Level of experience: new to or limited experience on pharmaceutical facilities, also recommended for those with hands-on experience but new to QA or validation of aseptic manufacturing facilities
Why follow this training
- provides an extensive overview of aseptic manufacturing facilities
- covers the new Eudralex annex 1 requirements on pharmaceutical facilities in depth
- complete overview of cleanroom qualification in accordance to ISO 14644 and the new Eudralex annex 1
- online self-paced training is time and cost efficient