Training
This must happen before an employee performs a task independently.
What is training?
This type of ink must be used when filling out official records.
What is permanent ink?
CAPA stands for this.
What is Corrective and Preventive Action?
GMP stands for this.
What is Good Manufacturing Practices?
Training records must be this to prove someone is qualified.
What is documented?
GDP requires that all entries in documents be this — not messy or hard to read.
What is legible?
A corrective action is taken to fix this.
What is a problem or nonconformance?
GMP helps ensure that products are safe, effective, and of this.
What is high quality?
This type of training is required when procedures or job roles change.
What is retraining?
If you make a mistake in a document, you should do this instead of erasing it.
What is draw a single line through it, then sign and date?
A preventive action is taken to stop this from happening.
What is a potential problem?
Wearing this helps prevent contamination in clean areas.
What is protective clothing or PPE?
Employees must demonstrate this to confirm they understood the training.
What is competency?
This must be done immediately after completing a task, not later.
What is record the data?
This tool is often used in CAPA to find the root cause of an issue.
What is a root cause analysis?
GMP requires that equipment be cleaned and this before use.
What is validated?
This document outlines what topics must be covered in a training session.
What is a training plan or curriculum?
GDP ensures that documents are this, meaning they can be traced back to the person who made the entry.
What is attributable?
CAPA effectiveness checks are done to confirm this.
What is that the issue is resolved and won’t recur?
This type of documentation proves that a product was made according to GMP.
What is batch record?