Part 1: introduction
Understand basic concepts such as cleanrooms, airlocks, HVAC, isolators and RABS.
Part 2: regulatory background
Covers the regulatory GMP requirements (US, EU) including the new Eudralex annex 1. Learn where to find and how to meet regulatory requirements on aseptic manufacturing.
Part 3: intermezzo on contamination
Part 4: cleanrooms
Covers in detail cleanroom, HVAC and facility design.
Part 5: cleanroom qualification
A technical introduction to cleanroom qualification in accordance to ISO 14644 and Eudralex Volume 4 annex 1. Covers all qualification tests required by the new annex 1.
Part 6: operational controls
An overview of operational aspects such as maintenance, cleaning and disinfection.
Part 7: barrier technology
Introduction to isolator and barrier technology, also covering disinfection and transfer technologies such as VHP, dry heat, E-beam.