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Quality Month 2017 - Janssen, Athens

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