Last Friday, the team of consultants attended a “Basics in Validation and Validation Protocols” training at the Biotech Training Facility (BTF) in Leiden. Led by specialist Marjon, we were immersed in GMP, URS’s, SOP’s and other terminologies.
Better understanding of our candidates and colleagues
In recent years, we have been in frequent contact with Validation Engineers from the pharmaceutical industry. Many of our clients perform assignments where they are responsible for commissioning, qualifying and validating various types of equipment, systems, processes and facilities. A profession in itself that requires a lot of knowledge and skills.
None of the consultants at TailorMinds are technically trained and/or have work experience within the pharmaceutical industry. Despite this, we know through experience what is going on in the industry and we are able to make the right match. The desire is to deepen our understanding of the candidate and/or colleague. Therefor we contacted BTF with the request to give a training on validation to ‘dummies’.
Course components
The challenge for our trainer Marjon this day was: how do you explain this complex subject matter in a simple and clear way to otherwise trained trainees? We started by zooming in on the laws and regulations, guidelines and the V-model.
Based on this, we went through the steps of the URS, IQ, OQ, PQ and SOP for everyday items such as Lego bricks and a car purchase. In this, it quickly became clear to us how many things in our daily lives are standardized, or validated. The art in this is being able to establish in advance the protocols that can guarantee as much control over the process as possible in the future. Because there can be so many different factors and details, the advice was simple: divide the process into manageable parts.
Finally, we visited the training facility where we had a look at the water systems, air treatment and filtration and fermentation equipment. All in all, a day packed with jargon and new perspectives. Useful information for us to use in practice. We would like to thank BTF and Marjon for this instructive day!
Interested in working with or at TailorMinds?
Is your background within validation a lot more solid than ours and are you interested in new opportunities in the pharmaceutical industry? Feel free to contact us.
