WATERS CROMATOGRAFÍA

20th September

10:00 – 12:00

Farmaforum Workshop Room 2

Current trend in pharmaceutical QC: towards automation, risk management and reduction of out-of-specification (OOS) outcomes

Speakers:

Andrea Gheduzzi, Principal Pharma Sales Development Specialist

Summary:

Pharmaceutical regulations are evolving toward a risk-based approach as the new ICH* guidelines reach final passage in 2023.

Waters supports this trend by introducing new solutions designed to mitigate risk and facilitate work in analytical laboratories, from sample preparation to data and results management.

We invite you to this workshop where we will review the risk factors in pharmaceutical QC laboratories, and how to avoid and reduce them with the help of Waters’ latest solutions:

We will present a completely new LC system designed to mitigate risks by reducing errors in pharmaceutical QC labs. We will show how, with this advanced LC system, 41% of human errors can be eliminated and how risks identified during development can be accounted for and mitigated during transfer to the QC lab.

Another area of improvement is the automation of dilution and sample preparation. You will learn about the Andrew+ pipetting robot which, with a flexible robotic arm and a simple, intuitive interface, allows many pharmaceutical QC workflows to be fully automated. This results in significant risk reduction through the elimination of human error and contamination associated with pipette handling, while improving the accuracy of analysis.

Finally, we will focus on IT solutions: we will look at the importance of data management software (Empower) in risk management, and how you can implement digitization and integration of isolated files by using new IT tools connected to Empower, intended for QC labs and instrument management, and based on server or cloud solutions.

Join this workshop to learn more about current and future trends for pharmaceutical QC labs.

*Q9 (R1) on quality risk management, Q13 on continuous manufacturing and Q14/Q2 (R2) on analytical procedure development and validation.

Part of the workshop will be conducted in English.