An NSF International Company M11 - Medical Device Auditing Professional - How to Audit Series - Advanced Audit Techniques
PrintPart of Medical Devices Training Module 11
£1470.00 excl VAT
About this course
Auditing is a skill that requires fundamental knowledge and practice. This course takes you through the specific requirements for auditing as defined in ISO 19011 and, as it is medical device specific, identifies the specific behaviors, skills and audit planning necessary to be a successful medical device auditor. The course will provide you with an overview of FDA investigator training and EU notified body auditor training, as well as enable you to learn effective ways of quickly identifying non-compliance through active mentoring from some of Europe’s most experienced notified body auditors. We examine audit planning, conduct and non-compliance identification but concentrate upon audit trails, sampling and nonconformity identification. The course uses examples of medical device processes throughout, enabling you to address your internal auditor training needs.
Who Should Attend
Any professional with the responsibility for internal, supplier or third party audits where understanding the best practices for medical device auditing is crucial. This module establishes you as a thoroughly trained auditor in the field of medical device regulatory compliance. Pharmaceutical quality professionals now responsible for medical device organizations will benefit greatly from this course.
