Ondemand Webinars

Implementing FDA-recommended approach for controlling Nitrosamines impurities

Mar 11, 2022
45 Min

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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