21 CFR Part 1271 – Lead Auditor

This specialized training bundle prepares professionals to serve in the role of **21 CFR Part 1271 Lead Auditor**. By completing both courses, trainees develop an understanding of regulatory requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps), 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 1271 – Lead Auditor certificate, recognizing specialized training in auditing HCT/P operations for compliance with applicable FDA requirements.