GLP-GMP mutuato
GLP-GMP
| A.Y. | Credits |
|---|---|
| 2021/2022 | 6 |
| Lecturer | Office hours for students | |
|---|---|---|
| Diego Puglié |
| Teaching in foreign languages |
|---|
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Course with optional materials in a foreign language
This course is entirely taught in Italian. Study materials can be provided in the foreign language and the final exam can be taken in the foreign language. |
Assigned to the Degree Course
| Date | Time | Classroom / Location |
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| Date | Time | Classroom / Location |
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Learning Objectives
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
Program
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
Teaching Material
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
| « back | Last update: 09/06/2022 |
