Medical Devices Awareness Training
Avge Pass Rate: 89 % | 2 attempts to pass the final assessment.
Our Medical Devices Awareness course was created as a useful introduction for both newcomers and established personnel.
In this course you will learn the importance of the requirements ISO13485, it’s relationship with ISO9001, and of Good Distribution Practice (the GDP Guidelines 2013/ C 343/01.) Above all, you will know how to implement and maintain quality and compliance with GDP within your company, as is required by the MHRA.
Your training is still a yearly requirement and the course is a perfect introduction to the subject, as well as excellent regular annual refresher training. The course allows you to learn at your own pace, helping to eliminate stress and expense to you or your company.
See our Course Content list below for more information on the modules included in this course.
The learning objectives of our Good Distribution Practice (GDP) Awareness course are:
- To understand the importance and requirements of GDP, in line with GDP Guidelines 2013/ C 343/01 and MHRA HMR2012.
- To recognise and understand your role in implementing and maintaining GDP compliance within your company day to day.
- To understand the role and function of the Responsible Person (RP) and the Quality Management System (QMS).
You will also learn:
- What to do in the event of a deviation or non-conformity.
- The dynamics of CAPAs and Change Controls.
Click the button below for supporting documentation about GDP if you wish to continue your learning journey.
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Help and Support
I like the fact reminders and module features. I struggled with the wording of 4 questions based on the ISO standard and course material