
Customised
Training at Your Premises & Distant Learning Modules
Why is Training a necessary investment: "Staff Training &
Competence in FDA & CE Mark Compliance is a regulatory requirement" - a
lack of training of your staff will rank as non-compliance!
|
At Your Premises
/ Sites -Courses available
|
Distant Learning
Modules -
|
|
FDA CFR 21 Regulations, QSR, Y2K &
Latest Requirements
- 1 Full Day QSR - For all
Line Managers & Supervisors
- 2 Full Days QSR, DMR, DHF,
510(k), PMA, Submissions - For Regulatory & Quality Managers
|
Being Updated
|
|
Understanding the Medical Devices
Directive (93/42/EEC)
- 1/2 Day General Introduction -
For All Staff
- 1 Full Day Standard Course
- For Line Managers & Supervisors
- 2 Full Days - Comprehensive - For
Regulatory & Quality Managers
|
Being Updated
|
|
CE Auditing Compliance
- 1 or 2 Full Days - For your nominated
Audit Staff
- Training Your Staff On Your
Premises Practical Auditing
- Regulatory Compliance - No more
Notified Body Non-compliances at your Surveillance Audits
|
Being Updated
|
Practical Hands-on guidance
working with Staff,
your Quality Management System,
your SOP's & WI's,
Technical Documentation, your
Processes, your Devices
Achieving Full Regulatory
Compliance