Dipl.-Ing. Ariane Pieters

Pharmaceutical and Cosmetic - Validation Master Plan - Process Validation - Cleaning Validation - Analytical Methods validation - Equipments, Utilities and Facilities Qaulification

Consulting for pharmaceutical and cosmetics industry Customer references : Sanofi Pasteur, Genzyme, Chanel

Medical Device - Process validation - Risk analysis - Validation system setting up

Medical device Harmonization and Compliance of the in-process controls - Technical documentation analysis (product/process description, FMEA, control plans, Validation Master Plan, qualifications IQ OQ PQ, Procedures SOP, Norms 21CFR820...) - Gap analysis - Improvement actions setting up (validation, SPC, work instructions modifications et trainings, PFMEA…)

- Quotation for new projects (working time, tooling) - Production line design (process flow chart, specifications, tooling and machines trials, PFMEA, control plan) - Feasibility commitment - Tooling orders following et and line installation in our production sites (Morocco and Egypt) - Line validation (PPAP) and customer audits - Production launching - Customer’s events (8D, sorting, reworking and quality wall setting up)

Workstation analysis Design of new workstations with Catia v5

Analysis of the side door closing hardness

Planning of new workstation