Course DatesTo be verified
Ready for FDA?
€795 (10% discount for Plastic Ireland/Ibec members) including course manual, lunch and refreshments.
Dates: To be advised
Who should attend?
Personnel in Quality, Design, Regulatory, Engineering, Operations and Suppliers to the medical device industry who are responsible for managing, implementing and using Medical Device Systems which may be subject to FDA Inspection.
Training Benefits will include:
* First hand information on FDA Inspection experiences
* 21 CFR Part 820 – implementing all of the requirements into your system
* Key issues everyone in the organisation should know
* A system V’s records focused inspection
* The Quality System Inspection Technique – QSIT
* How to evaluate your overall state of compliance
* Closing the gaps
* The Team factor
* Project Management of preparations
* Consequences of a poor inspection result
* Identifying appropriate Front-Line personnel for the inspection
* During the audit – key watchouts
* The format of the 483 observation
* The FDA Warning Letter
* Responding to Observations
Every participant will have the opportunity to identify their key requirements in advance of the course.
Free individual follow up consultation will be available post training from your course tutor.
7 Centre Court, Blyry Business and Commercial Park, Athlone.
The successful completion of this programme by the learner does not lead to an award, but a certificate of attendance is issued to each participant.
Safety Shoes – Not Required on this course