Common questions
Who will conduct our QSR training?
Emergo’s QSR training is conducted by Senior Consultants and Certified Auditors who spend a majority of their time helping medical device companies implement quality systems. They are in tune with the needs of the industry and approach the training with an eye on the practical aspects of meeting the regulations.
How is the training customized to our organization?
Prior to creating the training, we will discuss your needs and concerns about QSR compliance. If you require more focus on a specific QSR element or need more information about medical device reporting, we can address the issues your company is facing.
Can we host the training at a nearby hotel or conference center?
We recommend holding the training at your facility, if at all possible, for two reasons:
- It conserves costs and eliminates travel time and expenses for your employees.
- A secured setting allows for more open discussion. You don’t have to worry about revealing proprietary information, and employees feel more comfortable asking questions relevant to your situation.
Who should attend the training?
The training is appropriate for all levels of employees from upper level management to assembly line workers. Training is designed to accommodate attendees.
Do employees receive a certificate after the training is completed?
Yes, we issue each attendee a signed certificate within one week following training completion. Employees must attend the entire session to qualify for a certificate. FDA QSR training records are often requested by FDA Investigators during their inspections, therefore training certificates should be kept on file within your company for each employee.
How long is the training?
Training generally starts at 9AM each day, runs until 5PM, includes a one (1) hour break for lunch, and two (2) shorter breaks in the morning and afternoon. However, this can be changed to suit your specific business needs.