FDA 2012 - Risk Assessment-Compliance Using Easy To Fill Out Documentation

Learn how to perform risk assessment as part of the risk-based approach to computer system validation.

Why Should You Attend:

This webinar will show how you can determine and document risk in a process to reduce system validation time and ensure compliance.

The presenter will share real life examples that make application of the techniques, covered in this webinar, understandable in the context of any validation project. The training will include a workshop for participants to perform their own hazard analysis so they are proficient in applying the risk-based techniques.

Areas Covered in the Seminar:

- How to identify risk and plan risk-mitigations?

- How to use the hazard analysis to make validation efficient?

- How to document the risk assessment using a template?

- How risk assessment reduces validation time?

- Determine risk in a process to reduce the testing effort.

- Traceability made automatic.

- Workshop exercises.