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EUSTITE inspector training

EUSTITE inspector training. 25 March 2009 Kate Rolfvondenbaumen. Aims of the presentation. To provide a brief overview of the EUSTITE inspector training program To explain the HTA’s participation and involvement.

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EUSTITE inspector training

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  1. EUSTITE inspector training 25 March 2009 Kate Rolfvondenbaumen

  2. Aims of the presentation To provide a brief overview of the EUSTITE inspector training program To explain the HTA’s participation and involvement

  3. European Union Standards and Training for the Inspection of Tissue Establishments (EUSTITE) A European Union (EU) funded project Three year project launched in December 2006 Includes representatives from 11 organisations from 10 EU Member States (MS) and the World Health Organisation

  4. Aims of the project To support MS in the implementation of regulatory tasks To promote standardisation of regulatory systems in the European community Developing a set of guidelines for use by Competent Authorities (CA)

  5. How does the EUSTITE training work? A total of four inspector training modules 15-20 participants in each session Attendance is funded by the project not the CA Two parts: six weeks of e-learning modules residential training module

  6. The e-modules Tissues and cells EU regulatory framework, Good Manufacturing Practices and advanced therapies Disease transmission by tissues and cells Guidance on inspection, audit and vigilance Validation, sterilisation and quality risk management Borderline products, import and export, traceability

  7. What the guidelines include • Qualification and training of inspectors • Inspection scheduling • Types of inspection • Conduction of inspections • Evaluation of the inspection process

  8. Consequences for the sector • The proposed guidelines contain several items which could impact directly on our DIs • For example, a change to the current inspection protocol: • inspection scheduling (full inspection every four years, two year interval could be office-based)

  9. Preparation processes Guidelines are recommending assessment of individual tissue and cell processes Involve much longer inspections, particularly for complex establishments HTA has responded and proposed this recommendation not be implemented as we want to keep the inspection process proportionate

  10. Current situation • The HTA has completed multiple phase 1 inspections and over 100 phase 2 site inspections under the Directives • As a result of this solid experience we are in a good position to identify areas in the guidelines that may pose implementation problems

  11. Our participation • Ensures our inspectors are aware of practices and procedures that are being used in other CAs • Allows us to influence the final drafting and implementation of the guidelines

  12. Summing up • Three year project to harmonise inspection processes • HTA has participated in the first two training modules • We have provided and will continue to provide feedback into the current guidelines • Any formal outcomes resulting from the project will be communicated to the sector

  13. www.eustite.org

  14. www.hta.gov.uk

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