Table of Contents

Table of Contents


Comparison of Endothelial Cell Measurements by Two Eye Bank Specular Microscopes

Transitioning from PK to DMEK in a Public Hospital in Southern Brazil: First Series of 24 Consecutive Cases


Letter from the Editor

Featured Article

EBAA Major Guidance and Standards Changes


EBAA Major Guidance and Standards Changes

HCT/P Case Presentations: Adverse Reactions and Product Deviations

Terminal Sterilization: One Eye Bank’s Experience

Manufacturing Arrangements: Industry Compliance

Manufacturing Arrangements: Industry Compliance


Martha Wells, MPH, RAC


My presentation focuses on some ideas and issues to consider for enhancing your contracts and auditing activities with your manufacturing partners to ensure they are in compliance with FDA requirements. I will provide you with information on how the 21 CFR 1271 requirement applies to you, applicable industry standards that have been developed as well as examples of how to address the requirement that focus on auditing tools.

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