21 CFR Part 11:

August 3rd 2017 03:30 - 07:00

√ Evolution of 21 CFR Part 11
√ Annex 11
√ Why they are Back in the News
√ Avoid 483’s and Warning Letters
√ Key Requirements of Part 11 & Annex 11 in Detail
√ Electronic signatures, digital pens, and biometric signatures
√ Learning from Recent Warning Letters related to Part 11
√ Detailed experience on validation / 21 CFR 11 compliance of a computer system

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