GxP Training

Regardless of which GxP guideline your organisation must adhere to, a key part of the process will be to ensure all personnel involved within the processes are qualified and competent to fulfil the roles and responsibilities. Examples of GxP standards relating to personnel training and competency:

Good Clinical Practice (GCP) - The clinical trials regulation (Regulation 12)
Good Manufacturing Practice (GMP) – 21 CFR Part 211.25
Good Distribution Practice (GDP) – ‘Responsible Person’ Regulation 10 (1)

Cobent’s Learning Compliance Suite (LCS) automates the training process to ensure personnel are trained on the necessary documents and courses to remain qualified to perform their role as part of GxP requirements.

Personnel are assigned the necessary training as part of their training plan
Alerts and notifications are sent to remind personnel of non-completion
Non-compliance is escalated to supervisors based on pre-defined rules to enforce a proactive compliance approach
Workflows and rules enforce business and compliance processes, so steps are not missed or skipped
Supervisor dashboards and reports provide instant identification and visibility over non-compliance prior to inspections or audits

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GxP Training

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