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| Data Integrity App |
Tips which helpful to during FDA
Inspection.
i.
Be
concise; answer only the question that is asked.
ii.
Always
be clear with the answers to questions.
iii.
Think twice before answering Question
iv.
Try to close & complete your answer as
closed circuit.
v.
Your answer will decide next question.
vi.
They find out loop hole in your system &
check any mal practice has been conducted or not.
vii.
Never predict question & ask again if not
understood question. Never judge question & be true and honest.
viii.
Ready to produce evidence what you have
answer question.
ix.
Be
positive and confident.
x.
Take
corrective actions if possible, commit only to what you can deliver.
xi.
DO NOT give
volunteer information.
xii.
DO NOT
guess or speculate.
xiii.
DO NOT
lie.
xiv.
DO NOT
argue.
xv. DO NOT panic.
“Trust but Verify “ Ronald Reagan
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| Data Integrity App |
Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.
- Basic Data Integrity Concepts
- ERES & Its Requirement
- CSV & Its best practices
- Mock Inspection and General Q&A
- Checklist for inspection
- Inspection Readiness
- Useful SOP’s
- Stay Regulatory Compliant.
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