Home

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

SHARE WEB-PAGE

Please use the links below

Copyright © All Rights Reserved