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Maryland Regulatory Issues Expert #44283

I have 40 years of experience, and specialize in the field of biologics with specific knowledge in the areas of blood and blood products, regulatory compliance and quality assurance. I have published on such topics as blood group serology and FDA regulations, compliance with FDA regulation and quality assurance. I have worked with blood centers to restore suspended US licenses and to blood centers and transfusion services to remove restrictions of Warning Letters issued by FDA. I also worked with a blood center to successfully remove the restrictions of a Notice of Intent to Revoke the US license.

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