1. Activities & Energizers
Rules of GDP Activity
Description
This activity works in reverse of the typical approach to teaching good documentation practices (GDP), and should be used with trainees who have had experience with documentation in GMP settings or who have previously learned GDP content in training, as it relies on that knowledge as the basis of the activity.
It can be used as a teaching tool or as a review/knowledge check, in both basic GMP training and/or refresher training situations. The activity requires 20-30 minutes to complete, and works best in sessions of 20 or less people.
In light of the MHRA releasing a data integrity guidance in January 2015, the activity has been updated to align with the terminology used by the MHRA.
The activity is provided as a downloadable zip file that includes the activity setup and facilitation instructions, instructions for content development, and presentation slides that can be used for the activity.
Design a Device Activity
Description
This activity teaches the concept of a medical device and risk classifications of medical devices. It can be used as a lead-in to training on medical device regulations, and will work in any average-sized classroom session. The activity requires approximately 15 – 20 minutes to complete.
You receive a downloadable zip file that includes the activity setup and facilitation instructions, instructions for content development, and presentation slides that can be used for the activity.
Reward Check Energizer
Description
This energizer quickly illustrates to trainees the impact of minor errors, and is especially useful during good documentation practices training. It clearly shows that every error is a potential problem, no matter how insignificant it may seem, and every error has an impact, short or long term.
The energizer requires less than 10 minutes, and works with any size audience with appropriate preparation.
The energizer is provided as a downloadable zip file that includes the content development instructions, activity facilitation and debrief instructions, content slides, and supplies required to run the energizer.