FEHLBAUM Philippe (EFOR-CVO)
Compétences
Quality & Regulatory Environment :
CAPA and problem solving.
Audit organization.
Setup quality system.
ISO 13485 / MDD / MDR.
GMP / ANVISA.
Qualification & Validation
Process validations IQ / OQ / PQ.
Design of experiment.
Critical parameters definition.
Process risk analysis.
Manufacturing Production Unit :
Lean Manufacturing.
Process risk analysis.
Kaizen – SMED – Process Flow.
Process optimization.
Cost of goods definition.
Process automatization / Robotics.
Project Management :
PMP Philosophy.
Steering committee lead.
Gantt Chart – Milestones.
Work Package definition.
Regulations & Standards :
ISO 9001 – ISO 13485.
MDD / MDR.
FDA.
GMP.
Diplôme(s) – Qualification – Certification
ISO 13485 / GMP – CE Marking – Various trainings.
Lean Management.
Time & Crisis Management.
ISO 9001 Quality Manager.
MBA – Post degree (auditor).
ETS Industrialization Engineer.
Engineer in Micro Mechanics.
Expérience
Experience in Medical Device, Manufacturing and Pharmaceutical industry.