Process validation and verification for all

Written by Rina Nir

Level your eQMS

Recently I was invited to give a Process validation and verification (V&V) presentation at the Medtec UK conference in London. My challenge was to create a presentation which is accessible to an audience with very different backgrounds: I wanted to introduce the newbies to the subject but have enough meat to keep the experts.

My solution was to involve a group of subject matter experts: I made 8 interviews and picked on the minds of people who are involved with V&V in different levels. I then distilled the input I got, in combination with my own experience, into six focus areas which are key to a successful process V&V. These six areas are:

1. Gain CEO commitment.
2. Establish a multidisciplinary team.
3. Start Early.
4. Know your suppliers and sub-contractors.
5. Map your process.
6.Manage the manufacturing records.
Each focus area is demonstrated by real life examples and rich imagery.
The audience loved the presentation!  You are now very welcome to watch it yourself, download and share forward.
[slideshare id=34903121&doc=processvvrinanirshared-140520082657-phpapp01]

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