GOOD LABORATORY PRACTICE-GOOD MANUFACTURING PRACTICE
GLP-GMP
A.Y. | Credits |
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2016/2017 | 6 |
Lecturer | Office hours for students | |
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Diego Puglié |
Teaching in foreign languages |
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Course with optional materials in a foreign language
English
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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Learning Objectives
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
Program
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
Learning Achievements (Dublin Descriptors)
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.
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
Teaching, Attendance, Course Books and Assessment
- 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 9001:2015
· ISO-IEC 17025
- Assessment
oral examination
- Disability and Specific Learning Disorders (SLD)
Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.
To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.
Additional Information for Non-Attending Students
- 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
- Disability and Specific Learning Disorders (SLD)
Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.
To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.
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