Life Science Quality is a Pharma Quality Europe department providing a fast and effective track for total quality management and personnel education in life science field.

• QUALITY MANAGEMENT SYSTEM :

  • Quality policy definition
  • Quality manual
  • Quality plans, Quality objectives and KPIs
  • Process mapping and SOPs
  • Documentation management process
• INTERNAL QUALITY AUDITS
• TRAINING

  • Training plans
  • In house courses
  • E-learning
  • Effectiveness check questionnaires
• RISK MANAGEMENT

  • Risk assessment
  • Risk analysis
  • Risk monitoring programs
  • Risk management SOP
• SUPPLIER QUALIFICATION

  • GxP audit /third parties manufactures, distributors, investigational sites, CRO) - audit to IT suppliers (qualified auditors tick-it & PDA) - audit to raw materials, process equipment laboratory instruments
• CAPA SYSTEM IMPLEMENTATION
• CUSTOMER SATISFACTION SURVEY
• PREPARATION OF INSPECTIONS (FDA/EU/Competent Authority)
• COMPLIANCE PROGRAMS AND READINESS PROJECTS - Front office & back office shadow room organization - Mock audits - Respond post inspection - Remediation plans