Using Risk Management to Design Aseptic Process Simulations - Seguridad Mania.com - España y América Latina

Using risk management to design aseptic process simulations: Annex 1 states that “QRM (Quality Risk Management) applies to this document in its entirety”. Does this mean we can use QRM to justify non-compliance with Annex 1 requirements? The answer here is obvious: No. So when and where can we use QRM? And for what purposes? During this webinar we will go through several real and practical examples for using QRM to design Aseptic Process Simulations (media fills): 1) When using QRM is not allowed, 2) When it is permitted; and 3) When it is mandatory.