Engineering

Process Engineering

  • Independent c-GMP Regulations Compliance Review, Audit, & CAPA
  • Feasibility Studies & Conceptual Design Ingénierie détaillée
  • Preliminary Design (Basis of Design, BOD)
  • URS, FRS, BOD, FDS
  • Design of Sanitary Process / Equipment, Clean Utilities, Bio-Pharmaceutical Systems
  • Detailed Design Engineering
  • Critical Process Parameters specifications
  • Process Risk Analysis Assessment according to P-FMEA standard  & Mitigation alternatives
  • Sanitary Design, Appropriate Material & Internal Finish Specifications according to ASME-BPE2009
  • Critical Instruments, Equipment spcifications & sizing optimization
  • Independent facilities & cleanrooms architectural elements compliance review & cross flow analysis according to ISO-14644 & c-GMP guidelines.

Project Management & Validation

  • Project & Engineering Management & Programmation
  • Construction management and Onsite Works Supervision
  • Gestion de des budgets et contrôle de l’échéancier
  • Cost management & schedule control
  • Health & Safety management & impacts assessment
  • Commissioning, Benchmarking, FAT, Start-up, SAT
  • Validation IQ/OQ support & review
  • Standard operating procedure (SOP) writing & cGMP training
  • http://www.linkedin.com/pub/aziz-chraibi-phd-eng/b/a38/170

Pharma Bio Expert, your cGMP Regulation & Engineering Compliance Partner