MOELGAARD

CONSULTING

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...