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Boston Convention and Exhibition Center

2018 年 06 月 24 日 9:00 上午 - 2018 年 06 月 24 日 5:00 下午

415 Summer Street, , Boston, MA 02210 , USA

#40: Smart, Innovative Risk-Based Auditing: Shifting the Paradigm

Instructors

Sarah Ann  Silvers, MS

Sarah Ann Silvers, MS

Head of Clinical QA, Orca Bio, United States

As Director, GCP Process Control & Compliance, Sarah oversees Ce3’s Clinical Quality Program- leading and conducting domestic and international audits (internal, sponsor, investigator, CRO, vendor, and TMF audits), writing procedure, educating staff and implementing regulation and guidance, inspection readiness, etc. Sarah is also a highly-regarded instructor in GCP. Sarah earned a MS in Regulatory Science and is a registered Quality Assurance Professional in GCP (Society of Quality Assurance).

Joanne  Malia, MS, MSc

Joanne Malia, MS, MSc

Director, Development Records Management, Regeneron Pharmaceuticals, United States

Joanne Malia is Director, Development Records Management at Regeneron Pharmaceuticals and responsible for the TMF group and Clinical Archives and is the Business Process Owner for the eTMF. Throughout her 25+ year career in life sciences she has worked for diagnostic, biotech, pharmaceutical companies and CROs. She serves on the CDISC TMF Reference Model Steering Committee, on the organizing committee for DIA’s Regulatory Information Document Submission Meeting and presents frequently at industry conferences.

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