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GMP Training
EU Good Manufacturing Practice
EU Good Manufacturing Practice
Curriculum
10 Sections
16 Lessons
30 Hours
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Introduction to EU GMP & Pharmaceutical Quality System
5
1.1
Overview of the EU GMP
1.2
Pharmaceutical Quality System (PQS)
1.3
Quality Risk Management (QRM)
1.4
Product Quality Review (PQR)
1.5
Questionnaire
10 Questions
Personnel & Training Requirements
5
2.1
Key Personnel Roles
2.2
Qualified Person (QP)
2.3
Training Programs
2.4
Personnel Hygiene & Health
2.5
Questionnaire
12 Questions
Premises & Equipment
0
Documentation & Record-Keeping
0
Production & Cross-Contamination Control
0
Quality Control & Stability Testing
0
Sterile Product Manufacturing (Annex 1)
0
Biological Product Manufacturing (Annex 2)
0
Radiopharmaceuticals (Annex 3)
5
9.1
Specific Risks & Controls
9.2
Production & QC
9.3
Documentation & Release
9.4
Personnel & Training
9.5
Questionnaire
0 Questions
Complaints, Recalls & Self-Inspection
5
10.1
Complaint Handling
10.2
Recalls
10.3
Self-Inspection
10.4
Quality Defects & Risk Reduction
10.5
Questionnaire
10 Questions
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