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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

Peter has an intense personal desire for true quality and value adding activities. He has a solid experience in strategic management and persistent to create results in combination with a depth knowledge and experience with true leadership and culture changes. He has an in-depth knowledge and understanding of the whole Medical Device and Pharmaceutical Industry from the resent 15 years in Novo Nordisk and know the challenges for value adding activities within all pharmaceutical engineering areas.

 

His strengths include a visionary and strategic mindset, strong leadership skills with an inspiring attitude together with the ability to turn ideas into action. He strives to achieve professional excellence through colleagues with different background. He has an in-depth knowledge about Lean philosophy and the importance of identifying cross-organizational improvement projects and the will to execute them.

 

He has internationally experience through project execution and actively intense volunteer committee work within relevant areas, i.e. ISPE and GAMP, and he is an often invited international speaker within the field of Pharmaceutical Engineering, with several lecturing given around the world, including China, US and Europe. He has been regularly trainer in several Danish organizations since the 90’s.

 

CURBIU IN PHASELL

 

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FAUCIBUS ADIPISCIN

 

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ALIQUM THE ESTIBULU

 

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MAURIS HAS GRAVIDA

 

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MALESUAD IN QUAM

 

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DICTUMI VESTIBULM

 

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Qualcon adress

Brabrandvej 28

DK-2610 Roedovre

Denmark

 

+45 26 27 55 23

web2@qualcon.dk

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