Training

Good Distribution Practice (GDP) training is a requirement for anyone involved in medicinal product wholesaling activities. The basic training needed is on the EU GDP Guidelines (2013/C 343/01) and the company’s Standard Operating Procedures (SOPs). All personnel will need this training before beginning their role and then continuously (we recommend at least annually). We also recommend tha the RP, management and licence holder have further training into all areas of GDP to ensure they have a solid understanding of what is required. Personnel should also have training specific to the area they are working in.

Paradigm Shift Consulting run a monthly face to face training course (alternating between 1-day intensive and 2-day courses) on the EU GDP Guidelines and the expectations of the MHRA, with the two-day courses involving a number of breakout activities to help further your understandingand give real life examples/scenarios. The course is ideal for the RPs and Management Teams.

Their online training site gdptraining.co.uk offers GDP courses covering a range of areas. These are ideal if you need to boost your knowledge on a specific area (e.g. Falsified Medicines or Outsourced Activities) or would like training that you can fit around your schedule.

If a large group needs the same training we can set up a ‘training group’ that automatically enrols them into the required course and you can allocate a ‘group leader’ to keep track of their progress.

For all courses there will be a pre and post training test to show an improvement in your results and competency in the subject. You will receive a certificate if you pass the final test, which should be kept in your records and used as evidence of training.

For online courses we can look at how long it took each trainee to answer every question, which is especially useful if you want them to carry out the assessment with no outside help.

Contact use with your training needs and we can recommend the best course(s) for you. If you need training for a large group, we can set up online group for you or a bespoke face-to-face training session at your site.