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Blood Products Training

European Blood Laws and GMP

A half-day training module putting the requirements into perspective for you. . .

Session 1: EU/UK Legal Basis – The EU Blood Directive

  • EU Directive 2002/98/EC “Setting standards …”
    • Buzz Group: Implications for the Blood Service and its staff
  • EU Directives 98/79/EC and 2000/70/EC (amending 93/42/EC)
  • Looking forward – the EU Directive on Tissues (2004/23/EC)
  • Regulatory Inspection of blood service activities

Session 2: Good Manufacturing Practice

  • An effective Quality Management System
    • Buzz Group: Making your commitment to Quality visible
  • Critical Aspects of GMP in Blood Collection
    • Documentation Systems – the evidence
    • People – the key to it all – training & development
    • Premises & Equipment – qualification, calibration & maintenance
    • Processing & Process Materials – managing your suppliers
    • Testing & Monitoring – making the results count
    • Traceability – managing electronic record systems like Trace
    • Managing Change – planned & unplanned change (deviations)
    • Quality Improvement – internal audit & self-inspection

The approach: short, punchy, presentations reinforced by group work (individual sessions will be tailored to the personnel attending)Objectives:

  • to give meaning and relevance of regulatory and GMP requirements to groups of personnel according to their job content and responsibilities
  • to encourage effective communication between groups