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Training Risk Management Lean GMP/13485:2016 (QMSR)
Training Process Auditor (Lean GMP/13485:2016)
Workshop / Training Process Management: Lean GMP
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Service: European regulatory device support
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QM Maturity
Summary of essential CPDS tools and services to reach Lean GMP
Now possible: One global QMS for Pharma Combination Products
CPDS strongly recommends to align with the FDA Quality Management Maturity program (QMM).
EU Legislation for drug-device combination products
Technical documentation review strategies
GSPRs Matrix
Quality Manual
Management review …… the engine
ISO TC Explaining Process Approach
Internal Auditing: Cornerstone of a robust QMS
Regulatory perspectives of combination products