Exam (elaborations)
CAPA Questions and Answers with Solutions 2024/2025
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CAPA Questions and Answers with Solutions 2024/2025
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CAPAWho is answerable for starting up and completing the NOE? - ANSInitiator and Action Owner
Who is chargeable for initiating and assigning Regulatory Authority Notification Assessment
(RANA) - ANSInitiator and Action Owner
Who accepts and completes assigned Investigation Actions and MRB Follow Up Actions? -
ANSInitiator and Action Owner
Who accepts and completes assigned CAPA Action Items - ANSInitiator and Action Owner
What does NOE stand for - ANSNotice of Events
What does RANA stand for? - ANSRegulatory Authority Notification Assessment
Who oversees the of completion of Action Items for a CAPA Plan - ANSInitiator and Action
Owner
Who implements CAPA Plans and completes Effectiveness Check actions? - ANSInitiator and
Action Owner
Who completes Laboratory Investigation Checklist for OOS or Aberrant/OOT end result
investigations - ANSInitiator and Action Owner
What is the aim of event initiation for a CAPA? - ANSEnsure the Notice of Event (NOE) is
sincerely documented and is in compliance
with applicable SOPs
How lengthy does the initatior ought to file and document the NOE? - ANS1 commercial
enterprise day from the event.
Action Item - ANSActions recognized in guide of the general CAPA Plan.
What are the 3 kinds of actions on an action plan? - ANSCorrective, Preventive, or non-stop.
CAPA Plan - ANSOutline of the scope of the CAPA and action items to be applied.
Continuous Improvement Actions (CI) - ANSContinuous improvement of first-class and
performance
focuses on improving inner and/or outside consumer pleasure through non-stop and
incremental enhancements to techniques and structures.
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