Elements of Medical Product Auditing

Description

Regulatory authorities are increasingly expecting on-going, competent assessments of internally and externally sourced processes and materials. This course provides foundational information on regulatory requirements and expectations for audits as well as the different types of audits and their purposes. Additional information includes how to plan, conduct, and report audits as well as the investigatory and assessment tools used in audits. Course material is appropriate for personnel new to auditing, experienced auditors that are assuming lead auditor responsibility, and senior management responsible for resourcing audit efforts and assessing the information obtained from those audits.