CORPORATE ACCOUNT
FDA Online Training Programs
mdiConsultants will work with your Human Resources department to set up
a corporate account to allow your employees to take the mdiConsultants'
FDA Online Training Programs.
Discount programs are available and are based on the amount of employees
registered for the courses, and will be billed directly to your company.
For more information, please contact us directly either by telephone
1-516-482-9001, or by email at
mdi Consultants, Inc, is excited to announce a new program for
the medical device industry.
mdi has set up a set of ON-DEMAND training programs allowing companies
to provide their employees with several training programs on relevant
FDA issues: QSR compliance, CAPA and Design Control.* Each program runs 1 to 1.5 hours and has a question and answer session
allowing the participant to get a certificate of training once they successfully pass the test.
*Return to this page often for
information on new training programs.
The courses are:
The FDA QSR/cGMP requirements for medical device companies
- A basis overview of the FDA regulatory requirements for the medical
device industry and an introduction into the QSR/cGMP requirements for
any medical device manufacturer.
Design Control: What you need to comply with the FDA
- A basis understanding of the FDA Design Control requirements and what is
required by a medical device company to implement a design control
procedure and meet the FDA requirements.
CAPA: Complaints, MDR and Installation
- An understanding of the CAPA requirements in the FDA QSR/cGMP and what
is necessary to deal with complaints, MDRs and device installation.
About The Test
- To pass the test requires correctly answering 16 of the 20 questions. If
the test
is not passed, both the training course and the test must be
retaken.
- When the test is passed, an individually serialized certificate of
training is issued.
Who should take the course:
- All medical device company’s employees wanting a basic understanding of
the FDA regulatory requirements concerning the QSR/cGMP, Design Control
and CAPA.
- New employees to the medical device industry to have an understanding of
what the FDA is and the regulatory requirements they would be
responsible for.
- To prepare the staff for any upcoming FDA inspection, in order to have a
better understanding on what to expect during the FDA audit.
Costs:
- $95.00 per course, per person
The course has been reviewed by former and present USFDA officials. The
mdi training Program has been found to cover all aspects of the
regulations and has been determined to be an excellent training for all
medical device industry employees from the Officers of the company to
the production staff.
To begin Online Training, Click
here |
