EXPERTISES

Expertises dei docenti consulenti

  • Gestione dei sistemi Qualità GMP
  • Inspection Readiness FDA/EMA, PAI e AIFA
  • Conduzione di GMP Audits (FDA/EMA, PAI e AIFA)
  • Project Management
  • GMP Deviations Investigations and CAPA management;
  • Human Error
  • GMP training in Quality Operations
  • Tecniche di training per GMP trainers
  • Qualifica dei fornitori in ambito GMP
  • Audit di compliance per API, materiale grezzo, produzione di eccipienti e Contract Manufacturing Organization
  • Conduzioni di audits per Contract Manufacturing Organization (CMO) per i prodotti cosmetici secondo la ISO 22716:2007
  • Affiancamento nella revisione/redazione della documentazione cGMP tipo: Manuale della Qualità, Procedure e Standard operativi, Master Plan della Validazione, Process Validation, report di investigazioni relative alla Cleaning Validaton e alle Contestazioni/Deviazioni
  • Aseptic Behaviour
  • Contamination Control Strategy e Annex 1
  • Cleaning Validation
  • Cross Contamination
  • Quality Risk Management
  • Computer System Validation & Data Integrity issues
  • Laboratory operations compliance evaluation; Evaluation of the Analytical test methods; Analytical Methods Development/Transfers; Stability program and reports, Laboratory Performance Optimization
  • LIMS (Laboratory Information and Management System)
  • Laboratory budgeting
  • PAT (Process Analytical Technologies) NIR,NMR, GC-MS,ICP,AA,HPLC/UPLC, Capillary Electrophoresis
  • Data Integrity; Laboratory Data Integrity
  • ICH Q3D Elemental Impurities/Risk Assessment for excipient
  • Automation , Standardization and Validation of Analytical Instrumentation
  • Automation & Standardization of Manufacturing Operations
  • Good Distribution Practice
  • Lean Six Sigma; Lean Laboratory; Lean QA e QC
  • Lean Project Management nello sviluppo prodotto e technology transfer

Soft Skills nelle aree tecniche:

time management, gestione delle riunioni, comunicazione efficace, team building,  leadership…
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