Amanda Grim Email & Phone Number

Amanda Grim is a CEO, Principal Consultant at Amanda Grim's GCP Audits, LLC based in Carolina Beach, North Carolina, United States, North America. Amanda Grim, BA (Medical Ethics), JD (Heath Care Law focus) 919.349.4798 North Carolina, USA AuditsByAmanda@gmail.com Over 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 Management Common 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.