ISO 22442-3-2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents. Requirements and Application

Categories: Regulations, Standards

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Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 General requirements

5 Literature review

6 Elimination and/or inactivation study of viruses and TSE agents

7 Final report

8 Review of final report

9 Routine monitoring and control of critical process parameters

Annex A (normative) Requirements related to literature review

Annex B (informative) Guidance on the elimination and/or inactivation study for viruses

Annex C (informative) Guidance on the elimination and/or inactivation study for TSE agents

Annex D (informative) Guidance on scaling down

Annex E (informative) Statistical evaluation of virus titres and reduction factors and assessment of their validity.

Annex F (informative) Calculation of reduction factors

Annex G (informative) Probability of detection of agents at low concentrations

Final Exam
This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion.

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A course by

Mark Durivage

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Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Introduction

Introduction

1 Scope

1 Scope

2 Normative references

2 Normative references

3 Terms and definitions

3 Terms and definitions

Terms Quiz

4 General requirements

4.1 Risk management

4.2 Sourcing and manufacturing process

4.3 General requirements related to validation

General Requirements Quiz

5 Literature review

5.1 Conduct of the literature review

5.2 Application of literature review output

5.3 Viruses

5.4 TSE agents

Literature Review Quiz

6 Elimination and/or inactivation study of viruses and TSE agents

6.1 General

6.2 Protocol

6.3 Conduct of the study

6.4 Interpretation of data

Elimination study of viruses Quiz

7 Final report

7 Final report

Final Report Quiz

8 Review of final report

8 Review of final report

Review of Final Report Quiz

9 Routine monitoring and control of critical process parameters

9 Routine monitoring and control of critical process parameters

Routine Monitoring Quiz

Annex A (normative) Requirements related to literature review

A.1 General

A.1.1 Methodology

A.1.2 Critical evaluation

A.2 Conclusions

A.3 Report

Annex B (informative) Guidance on the elimination and/or inactivation study for viruses

B.1 General

B.2 Selection of viruses

B.3 Design and implications of elimination and/or inactivation studies

B.4 Elimination and/or inactivation study limitations

Annex C (informative) Guidance on the elimination and/or inactivation study for TSE agents

C.1 General

C.2 TSE agents surviving inactivation steps

Annex D (informative) Guidance on scaling down

Annex D Guidance on scaling down

Annex E (informative) Statistical evaluation of virus titres and reduction factors and assessment of their validity.

Annex E Statistical evaluation of virus titres and reduction factors and assessment of their validity.

Annex F (informative) Calculation of reduction factors

Annex F Calculation of reduction factors

Annex G (informative) Probability of detection of agents at low concentrations

Annex G Probability of detection of agents at low concentrations

Final Exam This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion.

Final Exam

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Final Exam
This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion.