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Standard face-to-face training

Our main topics

Here is the list of the topics on which we can elaborate face-to-face training sessions for your teams.

 

Validation/Qualification

+ IT Infrastructure Qualification (Q21) – VQ030

+ Automated Systems and Manufacturing Equipment Validation – VQ040

+ Computerized Systems Validation (CSV) – VQ050

 

Quality/Regulation

+ 21 CRFR Part 11 and Annex 11 – Computerized and Automated Systems Management – QR320

+ The Data Integrity requirements – QR410

+ Medical Devices Regulation (FDA) – QR270

 

Risk Management

+ ICH Q9: Quality Risk Management – GR420

+ ISO 14971 Risk Management for Medical Devices – GR410

 

AUDITS/INSPECTIONS

+ Computerized and Automated Systems Suppliers Audit – AI530

+ Internal Quality Audit – Improvement and Compliance Tool (ISO 19011) – AI510

 

Projects/Engineering

 

Metrology

 

Statistics

 

Lean 6 Sigma

 

Please contact us for any specific need: + 41 (0)22 346 52 47 or formation@cvo-europe.com

 

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