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