#40: Smart, Innovative Risk-Based Auditing: Shifting the Paradigm
Sarah Ann Silvers, MS
- Director, GCP Process Control and Compliance
- Ce3, 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 S. Malia, MS, MSc
- Associate Director, Clinical Documentation Management
- Regeneron Pharmaceuticals, United States
Joanne Malia is Associate Director, Clinical Documentation Management at Regeneron Pharmaceuticals. She has worked in clinical research at various global biotech, device, CRO and big pharma companies in the areas of quality management, trial master file and computer system validation for over 25 years. She is a frequent presenter and workshop leader. She has a Bachelor’s degree in Biology and Master degrees in both Microbiology and Management.