Training courses and manual for training
WP10: Training courses and manual for training
On the basis of agreed documents: “Overall Guidance on organization of PPA system” and technical annexes, this WP will organise training courses and prepare “Manual for training CA inspectors that assess and authorize preparation processes of tissue, cell, and blood products”, to disseminate the approach throughout Member States. Possible overlapping with existing general inspection documents such as the EC Operational Manual for Inspections of TE and the recently issued deliverable by VISTART JA will be taken into account and clarified. In any case GAPP manual and
subsequent training will only focus on assessment and authorization of PPA processes.
Training course will be open to all Member States countries, as well as to Serbia and Moldova
Description of work and role of partners
The work of WP10 is strictly connected to the final results of the WP5, WP6, WP7, WP8 and WP9,
This WP will be led by the KCBTiK, a budgetary unit submitted to the Polish Ministry of Health, which tasks include the supervision and inspection of tissue and cell banks in Poland as well as the organisation of training courses on the recovery, collection, testing, processing, sterilization, storage and distribution of tissues and cells.
Task 1: design of training course.
Considering how extensive will be deliverables provided by the above-mentioned WPs, in the second part of the project two technical meetings will be convened by the WP leader. During the first technical meeting of WP10 (M20) the working group will agree on the design of the face-to-face training course contents: training materials incl. examples, case studies etc. After the first face-to-face training course, a summary will be provided by tutors with practical details and prepare the issues concerning a manual content will be discussed as well. At M35 the closing technical meeting will take place to agree on the last amendments needed to the definitive version of manual.
Task 2: face-to-face training
The face-to-face training courses will take place at M30 and M33 and each of them will last 2 full days at least, including theoretical and practical training. The arrival of participant shall be planned a day before the beginning of the course and their departure shall be planned the day after the ending of the course. The training courses will be organised in Poland and all the EU CA from both blood and tissue and cells fields will be invited to attend it. Two persons per organisation will participate to the training. Further participants could attend upon budget availability of their institutions or personal coverage of travel expenses.
Task 3: Manual for training CA inspectors
The training course designed and held in this work package will be documented. All materials such as lectures, examples, case studies will be used as the basis for the preparation of the Deliverable 10.1 “Manual for training CA inspectors that assess and authorize preparation processes of tissue, cell, and blood products”. The manual will be made available at M36 to all Blood, Tissue and Cell Competent Authorities in electronic version downloadable from project website and from ECAS, so that they can use them for national or regional inspector training in the future.
D10.1: Manual for training CA inspectors that assess and authorize preparation processes of tissue, cell, and blood products
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