Dr. Klaus von Jan
Herrmannstrasse 117
35037 Marburg
Germany

Mobil Germany: +49-160-4450024
Mobil Switzerland: +41-79-6866844

email: klaus.von.jan(at)t-online.de
Internet: www.crs-network.de

Other: Founder and Co-Owner of Compliance Systems GmbH

 

Education

  • Dr.rer.nat., certified Chemist
  • DQS lead auditor within the pharmaceutical, biotech, medical device industry as well as for service providers
  • Trainer for PTS Training Service

Professional experiences

  • Head of Quality Assurance / Quality Control of Millipore BioSyntech GmbH; Hamburg (Biotech Company)
  • Head of Quality Assurance of Chiron Vaccines, Marburg
  • Implementation and validation GMP-related IT systems in global pharmaceutical companies
  • Execution of audits and mock inspections
  • Implementation and development of GMP compliant quality systems
  • Handling and solving of FDA 483 / Warning Letters; Implementation of Quality Systems Improvement Programs (QSIP)
  • Process optimization of aseptic drug manufacturing
  • Extensive project work in the USA

Own company

  • Individually tailored measures to assure long-lasting positive change
  • Hands-on support for implementation of GMP improvement programs at all levels in a company
  • Proven success and many years of experience regarding dealing with authorities like FDA, SwissMedic, PEI; extensive experience with FDA inspections
  • Proven successful implementation of GMP systems within the pharmaceutical and biotech industry
  • Execution of training for employees and top management
  • Proven experience regarding development, implementation and validation of GMP-related IT-systems
  • Co-operation and sharing of experience in a coaching network and a consulting network
  • Supporting companies regarding planning and approval of pharmaceutical facilities

Individually tailored support of companies and individuals by
  • Considering the needs of the customer within all levels
  • Individually tailored training courses
  • Responsibility fort he success of provided services
  • Sustainable success instead short time profit
  • Consulting of pharmaceutical companies by development and execution of GMP/QA projects and initiatives

Typical projects

Mock-Inspections / preparation of FDA inspections
Conceptional Design of a new vaccines plant
Solving of Warning Letters / 483 at a sterile drug manufacturer
Implementation of GMP at an API manufacturer (Biotech industry)
Implementation / validation of an electronic document management system in a global pharmaceutical vaccine company
Implementation / validation af an ERP-system in a pharmaceutical company
Execution of GMP / QS trainings
Global harmonization projects / efficiency improvement project in a pharmaceutical company with different sites
FDA preparation of a company for manufacturing a biological drug using cell cultures
Qualification / validation / documentation of an aseptic manufacturing process in a US based pharmaceutical company for clinical trial materials using isolators only