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Biotech Week Boston
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Dawn Speidel
Director of Global Quality Assurance at Latham Bio
Speaker

Profile

Ms. Speidel has extensive experience in ensuring cGxP compliance within biologic, pharmaceutical and medical device industries, with a focus on Quality Assurance. As a global quality professional, she is committed to working with teams to create and maintain the highest possible quality standards. Ms. Speidel brings considerable technical expertise in cGxP compliance consistent with global regulations and industry expectations.

At Latham BioPharm Group, Inc., she is supports multiple clients to assure their phase appropriate programs meet or exceed industry cGxP requirements by drafting and implementing corporate Quality Manuals, Quality Policy’s, Device Management File, Risk Assessment, SOPs, providing audit support, batch record review, disposition, deviation and CAPA identification to closures.