Bioprocessing Webinar

Preserving Data Integrity: 21 CFR Part 11 Compliance and Osmolality as a Process Parameter

Is your data incomplete? Learn how data integrity applies for the pharma and biotech industries, especially where 21 CFR part 11 and EU Annex 11 are concerned.

Did you know that data integrity issues were cited in 65% of all FDA warning letters in 2017? The main reason was due to having incomplete data. In the Pharma and Biotech Industries this can be prevented by ensuring the trustworthiness and reliability of electronic records, a process that is also known as Compliance with Data Integrity. The highest risks, when not working in a compliant manner, lie in import bans, product recalls or even the closing of production plants.

Attendees will Learn the Following During this Presentation:

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