Amanda Grim, BA (Medical Ethics), JD (Heath Care Law focus) 919.349.4798 North Carolina, USA AuditsByAmanda@gmail.comOver 20 years of Clinical Quality Assurance (CQA) experience in pharmaceutical, medical device and biological product research (Good Clinical Practice / GCP), and more than 22 years of diversified experience in the health care industry. An independent QA and QM (Quality Management) consultant, GCP auditor, and QA project manager with a medically-focused professional education. Willing to travel extensively in the US and abroad. QA Consulting, Auditing, Training (Inspection Prep, GCP, SOPs, QMS), SOP Development, Gap Analysis, Quality Management System (QMS) Set-up, CAPA and Non-Compliance Management, Quality Risk ManagementCommon Audit Standards – ICH E6 (R2), ISO 14155: 2020, FDA 21CFR Parts 11, 50, 54, 56, 312, 600-601, 812, as well as experience using EMA and Canadian regulations.Audit Types performed: Investigational Site, Vendor, Pre-qualification, In-process, Clinical Study Report (CSR), CRO (Contract Research Organization), Mock Inspection, Database, Internal Process and System, TMF, Safety Narrative, QMS, etc.Vendor Audits: Pharmacovigilance (PV)/Medical Information, IRB, Full-service CROs, IRT/IXRS, GCP, Phase I Clinic, Central Clinical Lab, CTMS (Clinical Trial Management System), eTMF (electronic Trial Master File), DM/Biostats and Programming, Imaging (Radiological) Core Laboratory, Echocardiography and TDI Imaging, Clinical Packaging / Storage / Depot, Lab Instrumentation Software, Electronic Data Capture, Bioanalytical Labs, and an Animal Lab facility, etc.
Listed skills include Gcp, Capa, Quality Assurance, Auditing, and 34 others.
