Improving the compliance level
and product quality
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. The focus is on improving compliance level and product quality.
Competances are build up during practical experiences in Top Management and Specialist roles in several different companies.
MANAGEMENT SYSTEMS
- Quality Systems
- QMS processes
- Vision & Strategy
- REACH
- Lean (Toyota)
- Audit, ISO 9001
LEGISLATION
- Standards and interpretation
- GMP
- ISO 13485 / ISO 9001
- FDA / 21 CFR211 / 820...
- EMA Vol IV, Annex 11, 15
- ICH Q7, Q8, Q9, Q10,Q11
- GAMP / ISPE
RISK MANAGEMENT
- Usability
- Expert & Facilitator
- Trainer
- Advisor / Analysist
- Review
- Reliability Prediction
VALIDATION
- Verification
- Validation of Processes
- Qualification of equipment
- Software validation
- Protocols & test
- Reporting and CAPA
SUBJECT MATTER EXPERT, SME
Peter Werner Christensen, CPIP
Competences as above - Typical role as:
- Specialist / Subject Matter Expert
- Advisor / consultant
- Leadauditor within Quality Systems
- Project manager or project participant
- Department representative
Qualcon address
Brabrandvej 28
DK-2610 Rødovre
Denmark
Phone +45 26 27 55 23
e-mail info@qualcon.dk
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