Using Risk Management to Design Aseptic Process Simulations



11th March 2025 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Presented by Alberto Gonzalez, Global Sterility Assurance and Microbiology Associate Director at Takeda |BOOK FREE SEAT FOR THIS WEBINAR

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.

Presented by Alberto Gonzalez, Global Sterility Assurance and Microbiology Associate Director at Takeda

Alberto is a pharmacist with 15 years of multinational experience in the pharma and biotech industries. In his first roles he was responsible for Quality Assurance, Quality Systems and Quality Compliance for sterile products. In his current position with Takeda’s Global Sterility Assurance and Microbiology team he has had a pivotal role on the company-wide implementation of Annex 1. His expertise lies with Contamination Control Strategies, Aseptic Process Simulations and application of Quality Risk Management to aseptic production. This can be summarized in his motto: “Think Aseptic”. He is an invited speaker at industry conferences, is active in industry collaborations and teaches at post graduate centers.


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