When it comes to 21 CFR Part 11, organizations typically train their employees on the whys and whats associated with the regulation, however, few focus on the “hows.” The interpretation and how critical it is with multiple systems working together is often overlooked. But without it, organizations risk a lack of consistency across their organization which may result in stiff penalties such as seizure or injunctions. During this webinar, Holly Baldwin, UL senior validation advisor, explores functional competencies pertaining to Part 11.
- 21 CFR Part 11 and correlation to EU Annex 11
- 21 CFR Part 11 (Annex 11) interpretation and inspector’s guide
- Warning letters and Part 11
Holly Baldwin, senior vaildation advisor, UL, BLST-EHS division
August 2, 2018
Part 11 Interpretation and Compliance
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