Sandy Hedberg Email & Phone Number

Over 30 years of experience in the medical device, pharma, and biologics industry FDA inspection preparation and onsite support during auditsCompliance and quality audits of Medical Device manufacturing, Blood and Tissue Establishments, PharmaCreation of custom procedures compliant with FDA requirements and ISO standardsPerformed FDA Consent Decree mandated independent computer system process and validation assessmentsExperienced in developing CAPA files including complaint analysis, Risk Analysis and Health Hazard Analysis, Investigations and Root Causes, Preventative actions and closure statementsPerformed validation of quality system softwarePrepared procedures for the validation and control of quality system softwareTest Protocol Development and Execution Experienced in executive management, project management, developing project plans, software quality assurance documents, software V&V plans, writing requirements, performing traceability analysis, work instructions, risk assessmentsPrepare, review and submit regulatory submissions to FDA

Listed skills include Fda, Validation, Quality System, Medical Devices, and 45 others.