PRAKAAR TECH - PHARMA COMPLIANCE
PRAKAAR TECH - Pharma Compliance & Validation Training
Master CSV, GAMP5, 21 CFR Part 11 & Calibration with real-world guidance from Kailas Navale, CSV Expert.
📚 EXPERT TRAINING:
🔹 CSV (Computer System Validation) - Parts 1-5
🔹 GAMP5 & Risk-Based Approaches
🔹 21 CFR Part 11 - Electronic Records
🔹 Calibration & Temperature Mapping
🔹 FDA Compliance & Career Guidance
SUBSCRIBE FOR: Weekly pharma compliance training, validation tutorials, career tips & regulatory updates.
Perfect for: QA engineers, validation specialists, compliance professionals & pharma teams.
📧 Ranucal Services: Kailasnavale@ranucal.in
🌐 www.ranucal.in
kailasnavale87.myinstamojo.com/product/how-to-choo…
#CSV #GAMP5 #Pharma #Validation #Compliance
PRAKAAR TECH - PHARMA COMPLIANCE
Watch this
4 weeks ago | [YT] | 3
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PRAKAAR TECH - PHARMA COMPLIANCE
During calibration, the accuracy of a Master Instrument should be
7 months ago | [YT] | 2
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PRAKAAR TECH - PHARMA COMPLIANCE
This channel shares practical GMP and compliance learnings from real cases.
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7 months ago | [YT] | 0
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PRAKAAR TECH - PHARMA COMPLIANCE
GAMP 5 isn’t just a validation guideline—it’s a way of thinking. It recognizes that not all software deserves the same level of trust or control, so it applies human judgment and risk awareness to computerized systems that impact patient safety and product quality. An Excel sheet used for scheduling training doesn’t need the same scrutiny as an MES controlling tablet compression or a custom algorithm calculating drug dosage. GAMP 5 says: validate what matters most, don’t over-engineer what doesn’t, and always focus on risk to the patient. It bridges the gap between blind compliance and blind trust, turning validation from paperwork into a meaningful, risk-based assurance that technology is truly fit for its intended use.
#GAMP5 #CSV #PharmaQuality #DataIntegrity #Validation #GxP #QualityMindset
7 months ago | [YT] | 4
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PRAKAAR TECH - PHARMA COMPLIANCE
Most people think CSV is only for GMP.
But CSV is actually about trusting your data and decisions — regulated or not.
8 months ago | [YT] | 2
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PRAKAAR TECH - PHARMA COMPLIANCE
What is the main purpose of CSV beyond GMP?
8 months ago | [YT] | 3
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PRAKAAR TECH - PHARMA COMPLIANCE
Which non-GMP system needs validation the most?
8 months ago | [YT] | 3
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PRAKAAR TECH - PHARMA COMPLIANCE
Why do companies apply CSV in non-GMP systems?
8 months ago | [YT] | 2
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PRAKAAR TECH - PHARMA COMPLIANCE
Where do you think Computerized System Validation (CSV) is required?
8 months ago | [YT] | 3
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PRAKAAR TECH - PHARMA COMPLIANCE
Open System – 21 CFR Part 11
A system where system access is not controlled by the record owner and data is stored or accessed outside the plant network.
Examples:
Calibration management software maintained on vendor servers
Finished goods testing data generated by CRO / CDMO
Both are Open Systems under 21 CFR Part 11.
8 months ago | [YT] | 0
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