Quality Context provided IMP GMP training to a virtual pharmaceutical company and clinical trial Sponsor wishing to improve their Clinical Project Manager’s understanding of the GMPs required for manufacture and distribution of clinical trial products.

Scope

We were tasked with:

  • Delivering a half-day training course to approximately twenty people with some understanding of the subject.
  • Providing background information on the subject areas and setting in context why the GMPs for IMP manufacture and distribution are so critical.
  • Discussing industry hot topics in the field and taking questions from the audience.

Solution

Deliverables:

  • A half-day training course at the client’s site which covered theoretical background and information on applicable legislation alongside examples of industry best practice and typical problem areas.
  • A number of interactive breakout sessions during the training to embed the theoretical learning delivered in the training presentation.
  • A short and simple training quiz to assess trainees understanding of the material covered.
  • Attendance certificates for all trainees.

Success

  • We received very positive feedback from the attendees and company contacts on the presentation and material delivered during the session.
  • We have been asked to repeat the session again the following year.