formateur-homme

LOMBARDO Frédéric (EFOR-CVO)

Compétences

Quality Systems

  • Implementation, updating, improvement of PQS / QMS
  • Processes, management, reviews, KPls, Risk analysis,…

Operational Quality

  • Deviations, complaints, CAPA, PQR handling
  • Task forces for crisis issues, optimization of process flows

Deputy QP

  • Batch release
  • Relationships with health Authorities

Team management

  • Team manager of technicians and engineers/pharmacists
  • Selection, support, evaluation and activity reviews
  • Budget

Continuous improvement / Lean manufacturing

  • Trainings
  • Implementation of methods and tools (QRQC, auto-quality, A3, Gemba, VSM, etc)

Audits

  • Compliance audits (EU authorities, FDA, AQSIQ, ANMV, NOTIFIED BODIES, etc).
  • Customer audits.
  • External audits and self-inspection.
  • Mock audits (GMP, cGMP, ISO, QSR).

Trainings

ICHQ7, Q8, Q9, Q10, MRP, Lean, BPF/GMP, DS, Risk Management, ISO 9001, ISO 13485, ISO 17025, ISO 19011, 21CFR820, MD US market, MDSAP, Data Integrity, Change Control, Validation, Investigation, CAPA, MDR, IVDR, Audit (GMP, ISO) and Mock inspection.

Diplôme(s) – Qualification – Certification

Pharm. D (doctor of pharmacy).
Master’s degree of management.
IRCA Certification.

Expérience

More than 24 years of experience in Industries of Health Products.
Global Audit Centre Leader : management of the Centre for Audit, audits, evaluations, trainings, consultancy, expertise, projects.
Head of the Centre for Audit and mission director.
Deputy QP responsibility.
Quality manager in development and production of pharmaceutical products.

Formations