Hexagon

Cleaning Validation Seminars

In cooperation with Progress PME and Shimadzu, we organise seminars on the topic of Cleaning Validation (...what if it fails) on a regular basis.

The seminar discusses why and how to adopt and implement a strategy of Cleaning Validation Lifecycle Management. We review how to work with a validation lifecycle approach, how to properly qualify the system, validate the methods, how to use TOC as one of the critical indicators in the cleaning process, and how to ensure continued verification, including correct TOC sampling and analysis.

The seminar does not revolve around normative storytelling as no two companies, products or manufacturing processes are alike. Cleaning Validation Life Cycle Management is to a great extent a matter of customisation, is based on pragmatic risk management, with consideration of all required Cleaning Validation attributes, including all relevant stakeholders.

We therefore strongly encourage individuals from QA, QC and manufacturing / operations to participate to these seminars, and to practice in the workshops how to identify the root causes for cleaning validation failures, across the whole chain of multi-disciplinairy activities. This specific approach also provides valuable insight to policy makers like Qualified Persons and Validation Engineers.

The next seminar is planned to be held in October 2017.