FDA Watch: Documented Training in a Qualified Network Environment

By Eric M. Stroud
GMPNetworks / Syvax Inc.

In order to complete the validation process for networks that require FDA Validation, one must provide evidence that training on network-related SOPs was conducted. A record of the training that was given for the network must be produced. This training record may be electronic or hardcopy.

Electronic training records are usually implemented at companies with a strong CBT program (computer-based training). After reading and possibly taking a short quiz, the electronic training record captures the name, date, topic, procedure #, score, employee ID #, and so on, as evidence of compliance.

More commonly, a training record is a simple form, which records the procedure title, trainer’s name, date, duration, and attendees.
Hint: Distribute the attendance list at the end of the training session!
The hardcopy training records must be maintained in a documentation repository.

If your company has a history of noncompliance with procedures (people not following SOPs consistently), taking attendance is not enough. It is good practice to implement a competency test following the training. This is typically a short quiz, not lasting more than 30 minutes. A threshold score is set, and all of the attendees meeting or exceeding the threshold score are allowed to perform a certain function. Those who fail the competency test must take the training again, and this highlights those colleagues that may need shadowing and observation.

In closing, “informal” training is not enough! Accurately record your training sessions, even if it is just one person in attendance. The creation of the training record is one of the key ingredients to show compliance with your own procedures.

Eric is an FDA Validation expert for GMPNetworks/Syvax Inc. Eric has over ten years experience with FDA validation for the pharmaceutical industry and has been specializing in validating IT data networks.
http://www.gmpnetworks.com