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Ondemand Webinars

FDA recommended approach for Nitrosamines impurities

Mar 11, 2022
45 Min
FDA recommended approach for Nitrosamines impurities

Proving the effectiveness of cleaning procedures for cleaning Nitrosamines during audits to regulators or customers has become a challenging task due to:

- Increased regulatory expectations based on recently published guidelines by FDA and EMA
- A limited number of Subject Matter Experts available to implement the methodology and present during Audits
- Maintaining a large volume of data across multiple spreadsheets & paper-records

In this webinar, we’ll see the new digital way of managing the Nitrosamines and similar Genotoxic Impurities using the CLEEN application built on the Leucine No-code platform.

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