Modern Validation - according to the latest FDA Guideline and the new EU GMP Annex 15

  • FDA’s Life Cycle approach to Process Validation
  • ASTM E2500 based verification
  • EU Annex 15 Qualification and Validation Planning and Implementation
  • Ongoing validation and Continued Process Verification
  • Validation planning
  • Validation plan assessment and optimisation
  • Validation assessments
  • Validation consulting


Pharmaceutical Manufacturing Technology services

  • Manufacturing technology strategy & compliance assessment
  • Control Strategy definition and implementation
  • Manufacturing feasibility studies and assessments
  • Product and process optimisation and root cause analysis
  • “Facilities of the Future” workshops, planning and implementation strategies


Customer Training Courses

  • Modern Process Validation, General
  • Modern Commissioning, Qualification and Validation
  • Quality Risk Management implementation
  • Quality by Design implementation


International Training Courses:

  • ECA: Process Validation
  • ECA: Continued Process Verification/Ongoing Process Verification
  • ECA: GMPs for Equipment, Utilities and Facilities
  • ISPE


Workshop facilitation and execution of follow-up implementation


Development of training material, SOP Writing


Change implementation and change management


And more...




Gert Moelgaard

Senior Consultant


Pharmaceutical Manufacturing Technology & Compliance


Gartnerhaven 18

DK 2800 Lyngby Denmark

T +4553792775