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.
Comparison of Endothelial Cell Measurements by Two Eye Bank Specular Microscopes
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
The International Journal of Eye Banking welcomes submissions from eye bankers, researchers, physicians or others involved in eye banking and corneal transplantation.
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