Holly Baldwin

Manager- Quality Validation-CSV, Sanofi Pasteur

She has 21 years of experience in the Life Science Industry (Pharmaceutical, Medical Device and Tissue Regeneration) and in SaaS company as a Computer System Validation authority and resource.
Expertise in 21 CFR Part 11 Assessments, Server Virtualization, Cloud Services (SaaS), IT Change Control, Validation Project Management, Testing Strategy (IQ, OQ, PQ, System Integration, UAT), System Development LifeCycle documentation, data migration strategy, Instructional Design and Training; FDA and worldwide Health Authority Audit preparedness, General Data Protection Regulation (EU privacy), Swiss Privacy Regulation;  California Consumer Privacy Act of 2018.
System Validation experience with Infrastructure, Virtualization, SAP and Oracle Enterprise Systems, Document Management Systems, Labeling systems, Learning Management Systems; Application Development and Testing systems; CAPA systems, FDA gateway for electronic submissions (ESG).