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Quality Month 2017 - Janssen, Athens

The "P" in CAPA.
Data must be recorded when the work is completed.
Used to document steps completed during manufacturing.
Department that tests samples to confirm product meets specifications
Our first responsibility is to the doctors, nurses, and ______...
Electronic system that tracks batches through the manufacturing process.
General name of medical device components manufactured in Janssen, Athens.
Launched in October 2017, it is the electronic system used to document quality issues.
Any modification to a validated process must be approved using this risk assessment record.
Data must be easy to read.
_______ is responsible for delivering high quality.
Data reflects what actually happened without edits or changes.
Proof that an instrument or device produces "correct" results.
J&J Regulatory Compliance team that periodically audits our site.
A chronological list of actions completed in an electronic system, which is reviewed as part of Data Integrity.
Theme of Quality Month 2017: Drive ______ quality, enable growth.
Good Manufacturing Practice
Data must be clearly linked to who did it.
Documented evidence that a specific process, operated within established parameters, will consistently and effectively produce a product meeting its predetermined specifications and quality attributes..
Refers to the completeness, consistency, and accuracy of data.
Everything we do must be of high _______.
Data must be the first, true copy.
The values that guide our decision-making are spelled out in this document.
Who is responsible for quality?
Document sent with product shipments; lists test results and conformity to specifications.
Acronym that defines the elements of Data Integrity.
Active Pharmaceutical Ingredient
Janssen is approved to manufacture API's by this US Agency.