Regulatory Affairs

22 Maio 2026, 17:00 • Rudi Micael Santiago de Oliveira

This calls covers the intense field of Regulatory Affairs in the pharmaceutical industry, mostly inclined to topics around drug substance. Concepts around GMP and ICH guidelines are important for anyone who later intends to work in the pharmaceutical industry.

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Quality by Design & Risk Assessment

15 Maio 2026, 17:00 • Rudi Micael Santiago de Oliveira

Here the students will understand the important concepts that are required to demonstrate a process was development with Quality and Robustness in mind, in a way that allows a team to design an adequate control strategy to ensure a process runs at scale as intended.

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Modeling & Simulation

8 Maio 2026, 17:00 • Rudi Micael Santiago de Oliveira

This class covers commonly used modeling tools that support process chemistry development. Examples are given for the various unit operations. The impact of modeling and simulation goes beyond saving time in the lab, it also contributes to higher process understanding which adds value when scaling up processes

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HSE & Process Safety

24 Abril 2026, 17:00 • Rudi Micael Santiago de Oliveira

Safety first. This class is meant to provide a general overview of the risks associated with API manufacturing and the efforts that should be made during process development to address those risks.

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Analytical Chemistry

17 Abril 2026, 17:00 • Rudi Micael Santiago de Oliveira

Analytical chemistry covers the vast array of analytical techniques that can be used to control the quality of the products that are made in the pharmaceutical industry. Additionally, the analytical control is also performed in the middle of the process, as in-process control (IPC).

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