Quality Context provided Good Distribution Practice training to European distributor of Active Pharmaceutical Ingredients and excipients. The client wished to train new quality staff in the requirements of the updated EU GDP Guidance to allow staff to implement the required changes in legislation within the company.

Scope

We were tasked with:

  • Delivering a one-day training course on Good Distribution Practice.
  • Providing background information on the subject area and setting the legislative requirements in the context of the client’s business and quality system.
  • Discussing industry hot topics and impending legislative changes within in the field and providing advice and guidance in these areas.

Solution

Deliverables:

  • A comprehensive one-day training course at the client’s site which covered the requirements of EU GDP requirements, expectations of Competent Authorities and industry best practice.
  • Practical breakout sessions to review the changes in legislation and industry expectations against the client’s current systems and procedures.
  • 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 on the presentation and material delivered during the session, in particular the practical application of the training in the context of the company’s operations.