During the course we will deal to  the problems and tools useful for a controlled management of analytical and production methods . Specifically, will be identified the  principles  to the definition and control of the relative processes, the reference standards and the relative prescriptions, the certification and recognition system . The course is organized in frontal  lessons including exercises aimed  to preparing and applying the tools for managing the process variables 

1. Quality product  levels

2. Quality minimum level of  and related protections: adaptive and proactive standards

3. Process quality as  quality product guarantee : management systems

4. The management criteria of process variables.

5. The  documentation principle and  prescriptive documents construction 

6. The voluntary and institutional certification-accreditation paths.

7. The requirements of a codified quality management system: the ISO 9001 standard

8. GMPs in the pharmaceutical sector: EU guidelines

9. Validation and qualification.

10. Controlled process management as an analytical results guarantee : Good Laboratory Practices.

11. Analytical data quality criteria and voluntary accreditation: ISO / IEC 17025

12. The “mandatory” GLPs for  research quality : Legislative Decree 50/2007 and OCSE guidelines

not present

The student must demonstrate that he has reached a sufficient level of mastery in relation to

• Knowledge and ability to understand the basic principles of management systems, documentability and response to proactive standards;
• Knowledge and understanding related to the application of proactive standards to complex production processes;
• Judgment autonomy in  application of  standards envisaged general principles ;
• Communication skills useful for the evaluation and presentation of regulatory standards, reference models and application examples;
• Ability to learn both the proposed standards and the methods of application to complex processes and realities (goods-services) of 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

not present

Teaching

Frontal lesson; exercises in the classroom and, as possible,  in  laboratory

Attendance

not provided

Course books

Normative appendix provided by the teacher, including:

• D.Lgs. 50/07
• Annex 1 to Legislative Decree 50/07 - OECD guidelines on GLP
• CE Guidelines on GMP
• Annex 15 GMP guidelines
• ISO 9001: 15
• ISO-IEC 17025: 18

Assessment

The learning outcomes will be ascertained through an oral interview; the choice of this method of assessment is considered by the teacher to be the most suitable for evaluating the knowledge acquired and the student's ability to logically and critically analyze the assimilated concepts. In fact, since the GOOD LABORATORY PRACTICE - GOOD MANUFACTURING PRACTICE course is largely based on rules and related methods of application of the same to management systems with topics strictly interconnected to each other, only through the oral interview will it be possible to evaluate the ability of the student to coordinate this knowledge and to deal correctly and completely with the situations and problems proposed. The oral interview will have an average duration of about 30 minutes and will focus on at least 4 different topics covered in the course to verify the level of knowledge achieved by the student in relation to the previously indicated educational objectives. In particular, within each topic the teacher will frequently intervene to ask for explanations and details on what the student has said in order to better assess the level of in-depth and understanding achieved. Particular emphasis will be given both to the expository skills in terms of appropriate terminology and to the logical skills that will allow the student to argue in its implications and in its entirety the subject matter of the examination question. in the light of the premises set out above, the knowledge of the topics, their presentation, the reasoning ability and the ability to make connections between the various topics will be taken into account, all elements which, in order of value, will respectively contribute to the achievement of the final score .

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.

Teaching

study activities - possible contacts, by email appointment, with   teacher

Attendance

not provided

Course books

Normative appendix provided by the teacher, including:

• D.Lgs. 50/07
• Annex 1 to Legislative Decree 50/07 - OECD guidelines on GLP
• CE Guidelines on GMP
• Annex 15 GMP guidelines
• ISO 9001: 15
• ISO-IEC 17025: 18

Assessment

The learning outcomes will be ascertained through an oral interview; the choice of this method of assessment is considered by the teacher to be the most suitable for evaluating the knowledge acquired and the student's ability to logically and critically analyze the assimilated concepts. In fact, since the GOOD LABORATORY PRACTICE - GOOD MANUFACTURING PRACTICE course is largely based on rules and related methods of application of the same to management systems with topics strictly interconnected to each other, only through the oral interview will it be possible to evaluate the ability of the student to coordinate this knowledge and to deal correctly and completely with the situations and problems proposed. The oral interview will have an average duration of about 30 minutes and will focus on at least 4 different topics covered in the course to verify the level of knowledge achieved by the student in relation to the previously indicated educational objectives. In particular, within each topic the teacher will frequently intervene to ask for explanations and details on what the student has said in order to better assess the level of in-depth and understanding achieved. Particular emphasis will be given both to the expository skills in terms of appropriate terminology and to the logical skills that will allow the student to argue in its implications and in its entirety the subject matter of the examination question. in the light of the premises set out above, the knowledge of the topics, their presentation, the reasoning ability and the ability to make connections between the various topics will be taken into account, all elements which, in order of value, will respectively contribute to the achievement of the final score .

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.