We have assembled the following documents about Medical Device Regulations from Health Canada as a service to the medical device community.
FDA QSR Training (21 CFR Part 820) for Medical Device Companies
ANSWERED ON THIS PAGE:
- Why should we train our employees on FDA QSR?
- What will our team learn in this training?
- What are the benefits of an exclusive on-site training?
FDA Quality System Regulation (QSR) compliance requires the full participation of everyone on your team. The FDA Investigator can show up without little to any notice, so it is important that your employees understand what they can do to help your company maintain compliance. Emergo’s FDA training is an intensive course conducted on-site by a senior Emergo consultant.
FDA training for one fixed fee, regardless of how many employees attend
Our training is available for a set fee plus expenses, providing a great value for companies training three or more employees at one time. On-site training gives your employees the opportunity to ask questions (something they cannot do easily in public or online classes) and allows employees to interact with one another during the training. Our training varies in length from one to three days.
What your team can learn in an intensive FDA QSR training class
The one-day class is an overview of the FDA QSR, while the two- or three-day training class provides more in-depth QSR training. The two- or three-day sessions can be customized to suit your company's specific needs, including:
- Overview of the US Food and Drug Administration (FDA)
- Overview of the FDA Quality System Regulation (QSR)
- General provisions of current Good Manufacturing Practice (cGMP)
- Responsibility of management
- Conducting audits, taking corrective action and documenting results
- Design controls including input, output, verification, validation, transfer, changes, and design history file
- Document control and records
- Purchasing controls and supplier evaluation
- Product identification and traceability
- Dealing with production and process changes
- Inspecting, measuring, and testing equipment
- Acceptance activities
- What to do with non-conforming products
- Corrective and Preventive Action (CAPA)
- Labeling and packaging controls
- Handling, storage, distribution, and installation
- Servicing of products
Our consultants have extensive medical device company experience, so your employees will receive high quality FDA training tailored to the needs of your organization.
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.
Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.
