Internal Auditor Training for Medical Device Companies

For device manufacturers, compliance with ISO 13485, US FDA, European, Canadian, and Japanese regulations can be challenging and conducting proper internal audits is a big part of maintaining compliance.

Emergo Group specializes in medical device quality assurance and regulatory affairs and can conduct on-site Internal Auditor Training to train your employees on how to conduct internal audits of your ISO or GMP quality management system.

A senior Emergo Group consultant will lead this GMP & ISO auditor training course on-site at your facility, saving you the time and expense of sending employees elsewhere for training.

Professional, on-site ISO and FDA GMP internal auditor training for one fixed fee, regardless of how many employees attend.

Our internal audit training is based on a set daily fee plus basic travel expenses. This makes it a great value for companies that need to train three or more employees at one time. On-site internal auditor training gives your employees the opportunity to interact.

What your team will learn in this intensive training class:

• Overview of ISO 13485:2003, FDA Good Manufacturing Practices (GMP), CE Marking and Canadian Medical Device Regulations (CMDR).
• Management responsibilities to customers, to quality policy, and to employees.
• Resource management: personnel, materials, infrastructure and facilities.
• Product realization from the planning stages through design development through interaction with customers.
• Ways to measure, evaluate, and improve performance within the organization.
• Requirements for incident reporting, technical files, and risk analysis.

The overview above describes Days 1 and 2 of the training. Day 3 is designed for new auditors and involves conducting a hands-on mock internal audit of your facility and processes. This is a great opportunity for your new auditors to take what they learned in the classroom during the previous two days and apply it in a real world setting in your company.

Please contact us for more information on our FDA GMP and ISO internal auditor training class.