21 CFR Part 11 – Lead Auditor

This specialized training bundle prepares professionals to serve in the role of 21 CFR Part 11 Lead Auditor. By completing both courses, trainees develop an understanding of FDA requirements for electronic records and electronic signatures along with the principles and practices used to plan, conduct, and manage effective audits.

Successful completion of the bundle results in a 21 CFR Part 11 – Lead Auditor certificate, recognizing specialized training in auditing electronic records, electronic signatures, and related systems and processes for compliance with applicable 21 CFR Part 11 requirements.