CE Marking, ISO 13485, GMP and CMDR. How they all fit together - 1 DAY
This ISO and GMP training class is conducted on-site by one of Emergo Group’s quality and regulatory professionals. Our training consultants have real world manufacturing experience and are not slick “canned” presenters that travel from city to city. This ensures that your team will participate in a high quality training session tailored to the needs of your organization.
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 expenses. This makes it a great value for companies that need to train two or more employees at one time. On-site training gives your employees the opportunity to ask questions (something they can’t do easily with online classes) and ensures that every employee is hearing consistent information at the same time.
What your team will learn in this intensive one day training class:
- Overview of the ISO 13485 standard, FDA GMP, CE Marking and Canadian Medical Device Regulations.
- Regulatory and reporting requirements.
- Agencies/Notified Bodies/Registrars involved in monitoring the US, Canadian, Australian and European standards.
- Specific areas in which the various regulations and standards differ from one another.
- How companies can modify their quality systems to meet ALL the standards with minimal duplication of effort.
- Minimizing the possibility of receiving an FDA 483 Warning Letter.
- Plus much more.
If you are interested in having Emergo Group conduct this training class for your company, please feel free to contact us.
