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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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