Скачать или смотреть Preparing for an FDA Inspection in Your IVF Lab

Course Description
This course prepares IVF laboratory teams and third-party coordination staff for FDA inspections related to human cells, tissues, and cellular and tissue-based products (HCT/Ps), including sperm, oocytes, and embryos. It outlines how to stay compliant with 21 CFR Part 1271, prepare for audits, and organize donor documentation. Participants will learn the top reasons for FDA citations, how to maintain an inspection-ready SOP manual and cycle binders, and how to develop a secure, traceable, and regulatory-compliant donor screening and eligibility system.

Learning Objectives
Identify the most common FDA inspection findings in IVF settings and implement strategies to avoid them.

Understand FDA requirements for anonymous, directed, and sexually intimate donor cycles.

Describe what documentation is required for donor eligibility determination and recordkeeping.

Prepare and maintain organized, audit-ready SOPs and binders.

Distinguish between applicable requirements for different donor types (anonymous vs. directed vs. SIP).

Use publicly available FDA warning letters to benchmark and strengthen your quality systems.