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Boston Convention and Exhibition Center

2018 年 06 月 24 日 1:00 下午 - 2018 年 06 月 24 日 4:30 下午

415 Summer Street, , Boston, MA 02210 , USA

#33: Quality Tolerance Limits/Issue Management: Taming the Beast of Clinical Development Risk

Instructors

Susan  Callery-D'Amico, BSN

Susan Callery-D'Amico, BSN

Retired, Vice President, R&D Quality Assurance, AbbVie, United States

Susan Callery D’Amico is a pharma leader with extensive experience in quality assurance and clinical development. She is the VP, R&D Quality Assurance, AbbVie, with the mission to drive quality excellence and continuous improvement as a strategic advantage across the lifecycle of pharmaceutical products. Susan has held senior management positions in R&D and QA at RWJPRD (J&J), Novarits, and Reata. She has the breadth of drug development experience from early-man through post-marketing.

Tim  Grey

Tim Grey

Senior Director,R&D Quality Systems, AbbVie, Inc., United States

Tim Grey joined AbbVie in December 2013. He is currently Senior Director of Research and Development Quality Assurance leading the Quality Systems and Support Services team which includes Quality Systems, Documentation Management, training, QKM, QRM, CAPA, Qualification and Validation activities. Tim has spent his career developing, applying, and implementing quality systems principles across the GxP product development lifecycle. Before joining AbbVie, he was with Eli Lilly and Company in various Quality Assurance positions, including the role of a Lean Six Sigma Black Belt. Early in in his career he had the opportunity to work in the Aerospace industry at Rolls Royce Aerospace where he developed his passion for quality.

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