Friday, May 26, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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1. DONOR SELECTION.. 1

  • 1.1Medical and social evaluation. 1
  • 1.2. Physical evaluation of cadaveric donors. 3
  • 1.3 General impression. 4
  • 1.3 Specific inspection. 4

2. RECOVERY AND PROCESSING ENVIRONMENTS. 5

  • 2.1 Microbiological safety of tissue. 5
    • 2.1.1 Selecting the appropriate air quality for processing. 5
    • 2.1.2 Skin in 85% glycerol 6
      • 2.1.2.1 Rationale. 7
    • 2.1.3. Heart valves, cryopreserved. 8
      • 2.1.3.1 Rationale. 8

3.TISSUE SPECIFIC QUALITY CRITERIA. 9

  • 3.1.Amniotic membrane. 9
  • 3.2.Bone. 9
  • 3.3.Cornea. 9
  • 3.4.Heart valves. 9
  • 3.5.Meniscus. 10
  • 3.6.Skin. 10
  • 3.7.Tendons. 10

4. RISK MANAGEMENT. 10

  • 4.1 Introduction. 10
  • 4.2 What does risk management provide for your organisation?. 11
  • 4.3 What is risk management?. 12
  • 4.4 Relevant definitions in the risk management process. 12
  • 4.5 Description of the phases in the risk management process. 15
  • 4.6 Risk assessment. 16
    • 4.6.2 Risk analysis. 16
      • 4.6.2.1 Rating of potential hazards/assessment of risks. 16
    • 4.6.3 Risk evaluation. 17
    • 4.6.4 Risk control 17
    • 4.6.5 Risk reduction. 17
    • 4.6.6 Risk acceptance. 17
    • 4.6.7 Risk review.. 18
    • 4.6.8 Risk communication. 18
    • 4.6.9 Risk management tools – Methodology. 18
  • 4.7 Failure Mode Effects and Analysis  (FMEA) 18
    • 4.7.1 Short description of the FMEA method. 19
      • 4.7.1.1 Define occurrence/possibility and severity. 19
    • 4.7.2 Other risk management methods. 19
  • 4.8 Risk management in relation to legislation and guidelines. 20
    • 4.8.1 EU Directives. 20
    • 4.8.2 Risk management in relation to GMP/GTP. 20
    • 4.8.3 Training in risk management 20

5. TRACEABILITY AND VIGILANCE. 20

  • 5.1.Serious adverse reactions/events. 20
  • 5.2. Notification of serious adverse reactions (Recipients) 22
  • 5.3. Notification of serious adverse reactions (Living donors) 23
  • 5.4. Notification of serious adverse events. 23

6. VALIDATION.. 24

  • 6.1 Validation. 24
    • 6.1.1 Validation Master Plan. 25
    • 6.1.2 Protocol 25
    • 6.1.3 Report 25
    • 6.1.4 Equipment qualification. 26
    • 6.1.5 Clean Rooms and Laminar Flow Hoods Qualification. 28
    • 6.1.6 Process validation. 29
    • 6.1.7 Prospective validation. 29
    • 6.1.8 Concurrent validation. 30
    • 6.1.9 Retrospective validation. 30
    • 6.1.10 Cleaning and Disinfection Validation. 31
    • 6.1.11 Validation of Analytical Methods. 31
    • 6.1.12 Revalidation. 32
  • 6.2 Example of Transport validation. 32
    • 6.2.1 Objective. 32
    • 6.2.2 Scope. 32
    • 6.2.3 Responsibilities. 32
    • 6.2.4 Related documents. 32
    • 6.2.5 Critical validation elements. 32
    • 6.2.6 Method to perform the study. 33
    • 6.2.7 Results and acceptance criteria. 33
    • 6.2.8 Conclusions. 34
  • 6.3: Facilities disinfection.. 34
    • 6.3.1. Objective. 34
    • 6.3.2. Scope. 34
    • 6.3.3. Responsibilities. 35
    • 6.3.4. Related documents. 35
    • 6.3.5. Critical validation elements. 35
    • 6.3.6. Method to perform the study. 35
    • 6.3.7. Results and acceptance criteria. 36

7. CRITICAL THIRD PARTY AGREEMENTS. 36

8. IMPORT AND EXPORT. 38

9. CONTINUITY PLANS. 42

10. TISSUE ESTABLISHMENT DOSSIER. 43

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