Did you miss the European launch of the new ISPE Good Practice Guide on the risk-based approach to implementation of part 11? Then, here is a chance to catch up and learn about NNIT’s experience in the implementation of electronic records and signatures.

Seminar description
At the seminar, we will present the risk management model described in the ISPE document: GAMP Good Practice Guide – A Risk Based Approach to Compliant Electronic Records and Signatures.

The model is based on five steps, supporting identification of records and implementation of an adequate level of mitigating controls.

The seminar incorporates an in-depth description on how to interpret the GAMP guide, supported by practical examples.

Learning objectives
Understand the purpose, objectives, structure and key concepts of the GAMP Good Practice Guide and learn how to use it for optimisation of your validation projects.

Who should attend?
The seminar is aimed at professionals involved in compliance issues concerning computer systems that are used in the regulated industry.

See invitation