Internal Auditor Training for Medical Device and IVD Companies - 3 DAYS
For device manufacturers, compliance with US FDA, European and Canadian regulations can be tricky and conducting proper internal audits is a big part of maintaining compliance with all the various regulations.
Emergo Group specializes in medical device quality assurance and regulatory affairs and can conduct on-site Internal Auditor Training to train your key employees on how to conduct internal audits of your manufacturing facility(ies).
A senior Emergo Group consultant will lead this Internal Auditor Training course. Our training consultants are Certified Lead Assessors with real world manufacturing experience, not professional “canned” presenters. This ensures that your team will get a high quality Internal Auditor Training session tailored to the needs of your organization. Best of all, the training will be conducted at your facility, saving you the time and expense of sending employees elsewhere for training.
Professional, on-site training for one fixed fee, regardless of how many employees attend!
Our fee for training is based on a set daily fee plus basic travel expenses. This makes it a great value for companies that need to train more than two employees at one time. On-site training gives your employees the opportunity to ask questions (something they can’t do with online classes) and ensures that every employee is hearing consistent information at the same time.
What your team will learn in this intensive three-day Medical Device Internal Auditor Training class:
- Overview of ISO 13485:2003, FDA Good Manufacturing Practices (GMP) and Canadian Medical Device Regulations (CMDR).
- Regulatory and reporting requirements.
- Overview of a compliant quality system.
- 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.
- And much more.
This overview above describes Days 1 and 2 of the training. Day 3 will be spent conducting a hands-on mock internal audit of your facility and processes. This is a great opportunity for your employees to take what they learned in the classroom during the previous two days and apply it in a real world setting in your company!
If you are interested in having Emergo Group conduct medical device Internal Auditor Training for your company, please feel free to contact us.
