Quality Risk Management
You never know when it is serious!
Consulting Engineering
Company
Qualcon is a Consulting Engineering Company. It has a superior knowledge and provide a supreme spectrum of offerings within Medical Devices, Bio- and Pharmaceutical engineering.
Competances are build up during practical experiences in Top Management and Specialist roles in several different companies.
MANAGEMENT SYSTEMS
- Quality Systems
- Vision & Strategy
- Responsible Care
- Lean (Toyota)
- Audit, ISO 9001
LEGISLATION
- GMP
- FDA and 21 CFR...
- EMA Vol IV, Annex 11, 15
- ICH Q7, Q8, Q9, Q10,Q11
- GAMP / ISPE
RISK MANAGEMENT
- Expert & Facilitator
- Trainer
- Advisor / Analysist
- Review
- Reliability Prediction
VALIDATION
- Validation Planning
- Quality Planning
- Prepare Protocols
- Perform Test
- Reporting and CAPA
SUBJECT MATTER EXPERT, SME
Peter Werner Christensen, CPIP
Competences as above - Typical role as:
- Project participant
- Department representative
- Subject Matter Expert in relevant skills
Qualcon address
Brabrandvej 28
DK-2610 Rødovre
Denmark
Phone +45 26 27 55 23
e-mail web2@qualcon.dk
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