The course will address the issues and the tools for a controlled management of analytical methods and production. Specifically identified will be useful to define the principles and process control related, reference standards and related requirements, the system of certification and recognition. Classes will be front type and will expect activities esercitative readying times and application management tools of process variables

2. Minimum level of quality and relevant safeguards: standards adaptive and proactive policies

3. The quality of the process as a guarantee of product quality: management systems

4. The statutory management of process variables.

5. The documentability principle  and the construction of prescriptive documents

6. The certification paths-voluntary accreditation and institutional.

7. The requirements of a quality management system coded: ISO 9001

8. GMP in pharmaceuticals: EU guidelines

9. Validation and qualification.

10. The controlled management of the process as a guarantee of analytical results: the Good Laboratory Practices.

11. Criteria for data quality and voluntary accreditation ISO / IEC 17025

GLP "mandatory" for the quality of research: the D.Lgs.50 / 2007 and OECD guidelines

Students must demonstrate that they have reached a sufficient level of mastery regarding

Knowledge and understanding of the basic principles of management, dolla traceability and response standards proactive;

Knowledge and understanding related to the application of standards in proactive complex production processes;

Making judgments in relation to the rules for the application of the general principles set standards;

Communication skills relevant for evaluation and exhibition of regulatory standards, the reference models and application examples;

Ability to learn both the proposed standards that the implementing rules to complex processes and reality (real-services) production.

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

Teaching

Lectures; classroom exercises and, possibly, in the laboratory

Course books

Appendix legislation provided by the teacher, including:

· D.Lgs.50 / 07

· Annex 1 to D.lgs.50 / 07-OECD guidelines on GLP

· Guidelines on EC GMP

· Annex 15 GMP

· ISO 9001

· ISO-IEC 17025

Assessment

oral examination

Disabilità e DSA

Le studentesse e gli studenti che hanno registrato la certificazione di disabilità o la certificazione di DSA presso l'Ufficio Inclusione e diritto allo studio, possono chiedere di utilizzare le mappe concettuali (per parole chiave) durante la prova di esame.

A tal fine, è necessario inviare le mappe, due settimane prima dell’appello di esame, alla o al docente del corso, che ne verificherà la coerenza con le indicazioni delle linee guida di ateneo e potrà chiederne la modifica.

Course books

Appendix legislation provided by the teacher, including:

· D.Lgs.50 / 07

· Annex 1 to D.lgs.50 / 07-OECD guidelines on GLP

· Guidelines on EC GMP

· Annex 15 GMP

· ISO 9001

· ISO-IEC 17025

Assessment

oral examination

Disabilità e DSA

Le studentesse e gli studenti che hanno registrato la certificazione di disabilità o la certificazione di DSA presso l'Ufficio Inclusione e diritto allo studio, possono chiedere di utilizzare le mappe concettuali (per parole chiave) durante la prova di esame.

A tal fine, è necessario inviare le mappe, due settimane prima dell’appello di esame, alla o al docente del corso, che ne verificherà la coerenza con le indicazioni delle linee guida di ateneo e potrà chiederne la modifica.