Definition

Documentation demonstrating that personnel have been trained on pharmacovigilance procedures, regulations, and systems before performing related tasks.

Example

Before a new case processor handles cases independently, their training record must show completion of: GVP training, database training, SOP training, and competency assessment.

Regulatory source

EU GVP Module I, 21 CFR 211.25

Common mistakes

Relying on signature sheets alone without evidence of comprehension. Training should include competency verification.

Inspector question

Show me the training records for the person who processed this case. How do you verify training effectiveness?

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