
Projektledelse
Installation & validering
Teknisk udvikling
Specifikation & implementering
Lean 6 sigma
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Projektledelse
Installation & validering
Teknisk udvikling
Specifikation & implementering
Lean 6 sigma

General / Vendor & Project Management
Equipment specification & installation under GMP
Product development & production implementation
Validation (also with statistical methods)
Problem solving and road block removal

Worldwide Regulatory CMC
CTA Submissions
BLA/MAA/J-NDA
Global Roll Out
Life Cycle Management

Design control & medical devices: ISO 13485 & 21 CFR 820
Project management, Prince2 certification
Verification, production transfer and validation
Risk management according to ISO 14971
Biochemistry, molecular and cellular biology