Deviations in Pharmaceutical industry l Interview Questions

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  • čas přidán 12. 07. 2024
  • Here are the selected top 26 interview questions about deviations in pharmaceutical industry
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    Pick your favourite topic video from below playlist:
    1. QMS - Quality Management System in Pharmaceutical industry : • QMS - Quality Manageme...
    2. QA- Quality assurance in Pharmaceutical industry. : • QA- Quality assurance ...
    3. QC - Quality Control in Pharmaceutical industry : • QC - Quality Control i...
    4. OSD - Tablet Manufacturing in Pharmaceutical industry : • OSD - Tablet Manufactu...
    5. Injectable processing - Injectable processing or Sterile dosage formulation : • Injectable processing ...
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    Questions covered:
    Q.1 :What is Deviation?
    Q.2: Why we should raise deviation?
    Q.3: What is difference between incident and deviation?
    Q.4: What are the categories / classifications of deviation?
    Q.5: How do you classify deviations?
    Q.6: What is thumb rule for writing deviation description?
    Q.7: Planned deviations shall be raised or not ?
    Q.8: What is CFT and role of CFT in deviation investigation ?
    Q.9: What are the three stages / Levels of deviation?
    Q.10: Which investigation tools are used during deviation investigation ?
    Q.11: How do you select investigation tool ?
    Q.12: How do you perform deviation impact assessment ?
    Q.13: Why review of previous deviations is done during investigation ?
    Q.14: Why we should raise deviation within 24 hours of identification?
    Q.15: What should be the deviation closure timeline for minor, major and critical deviations?
    Q.16: What are the trigger points for deviation?
    Q.17: Which guideline most commonly referred for deviation handling ?
    Q.18: Which are the basic components of deviation investigation template ?
    Q.19: Why deviation count is important in QMS ?
    Q.20: Which Software / application is most commonly used for deviation handling?
    Q.21: Can we close deviation without getting root cause ?
    Q.22: Can we re-open closed deviation ?
    Q.23: Whether we should raise deviation for OOS / OOT results ?
    Q.24: Can we cancel close raised deviation ?
    Q.25: Can we cover / address multiple discrepancies in single deviation ?
    Q.26: What are the most common root causes for deviations?
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    Key words:
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