Amnon Eylath

Amnon Eylath 3 years ago By Yvie
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Sessions: Selecting a right-sized and cost-effective eQMS for the smaller company Applying effective and scalable sanitization/decontamination technology to prevent/remediate cleanroom contaminations Amnon Eylath is experienced in the complete life cycle of biopharmaceutical drug development: From R&D through preclinical studies, clinical trials, process development, manufacturing, validation and NDA submissions, to global distribution of commercial products. In 1990, Amnon obtained a Masters’ Degree in Biology from Harvard University and a Bachelor of Science Degree in Biology from the University of Massachusetts. Amnon is Head of Quality at Axcella Health where he is responsible for executing the quality vision and leading all GXP Quality activities and operations as a member of the Executive Lead Team. Amnon was the founder and chair of the PDA Task Force that issued Technical Report 56 (TR-56) “Application of Phase-Appropriate CGMP and Quality Systems to the Development of Protein Bulk Drug Substance”, working in collaboration with FDA, MHRA, EMA and global Industry peers. He also contributed to PDA’s TR-65 “Technology Transfer” and to various professional articles and presentations/posters. Amnon is Past President of the New England Chapter of the PDA.

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