Annual GXP Refreshers

Update: The new release is available!

How current is your cGMP Program?

Managing how current the “c” in CGMP is for refresher programs.

  • This white paper was originally released in 2012. A lot has happened in the Life Sciences industries since this first release. Over the years, I continued to receive several requests for the white paper, so the topic is still as pertinent as it was in 2012.
  • Yet, when I re-read it recently, I concluded that the original white paper was no longer meeting the needs of Directors and VPs who ultimately have the responsibility for GXP compliance; not just GMP Training.
  • GXP Training and its cousin, the Refresher, is so much more than choosing the topic, presenting the PowerPoint slide deck, and taking the knowledge check at the end. But if you only want to earn the checkmark, stop now and put aside the white paper.
  • If, however, you want to improve your compliance performance, lower deviations, and have more favorable inspections, it starts with improving GXP Refreshers.
  • This revision expands on the need for refreshers to include the following sections:
    • –  What is the bigger goal
    • –  Why Topic Selection is such a challenge
    • –  What can be considered for GMP refresher content
    • –  Why you need a process for content development
    • –  What is your process
    • –  Is your GXP Trainer GMP qualified?

Typical Requester:
Compliance Trainers, QS/QA Training Managers, L&D Trainers

How Used:

  • This white paper appeals to GMP Compliance Trainers looking for ideas for the annual GXP refresher.
  • It also appeals to Training Managers who want some insight into how the GMP refresher program should be managed.
  • Directors and VPs of Quality who are looking to improve their overall GxP Refresher Program will find new valuable insights in this second edition.
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