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Courses
GMP Trainings
Good Manufacturing Practices (EMA Focused)
Curriculum
11 Sections
41 Lessons
40 Hours
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Overview
1
1.1
Program Introduction
Module 1: Introduction to EU GMP & Pharmaceutical Quality System
5
2.1
Overview of the EU GMP
2.2
Pharmaceutical Quality System (PQS): Framework, Integration, and Accountability
2.3
Quality Risk Management (QRM)- ICH Q9 Application in GMP
2.4
Product Quality Review (PQR)
2.5
Questionnaire
10 Questions
Module 2: Personnel & Training Requirements
5
3.1
Key Personnel – Roles, Independence, and Shared Responsibilities
3.2
The Qualified Person (QP) – Legal Mandate, Qualifications, and Core Responsibilities
3.3
GMP Training Requirements – Program Development, Records, and Specialized Applications
3.4
Personnel Hygiene, Health & Contamination Control in GMP Operations
3.5
Questionnaire
12 Questions
Module 3: Premises & Equipment
5
4.1
Premises Design & Maintenance: GMP Requirements for Premises and Cleanroom Classifications
4.2
GMP Storage, Security & Controlled Access Systems
4.3
GMP Equipment Control – Qualification, Calibration, Cleaning & Maintenance
4.4
GMP Critical Utility Systems – Water, HVAC, Gases & Monitoring
4.5
Questionnaire
10 Questions
Module 4: Documentation & Record-Keeping
5
5.1
GMP Documentation System – Specifications, Instructions & Records
5.2
Good Documentation Practices (GDP): Data Integrity Principles in GMP Documentation and Records
5.3
Batch Documentation, Reconciliation & Retention
5.4
GMP Document Control System – Lifecycle, Security & Integrity
5.5
Questionnaire
10 Questions
Module 5: Production & Cross-Contamination Control
5
6.1
GMP Production Operations: Procedures, Line Clearance, and Deviation Control
6.2
Prevention of Cross-Contamination in Pharmaceutical Manufacturing
6.3
Process and Cleaning Validation, and Revalidation Requirements
6.4
GMP Control of Materials and Packaging in Pharmaceutical Operations
6.5
Questionnaire
10 Questions
Module 6: Quality Control & Stability Testing
5
7.1
GMP Quality Control: Structure, Sampling, Testing & Stability
7.2
GMP Laboratory Control: Specifications, OOS/OOT, and Reference Standards
7.3
Pharmaceutical Stability Testing – ICH Guidelines & Program Management
7.4
Analytical Quality Control: Method Validation, Transfer & Equipment
7.5
Questionnaire
10 Questions
Module 7: Sterile Product Manufacturing (Annex 1)
5
8.1
Sterile Manufacturing Cleanroom Requirements – Grades, Monitoring, and Control (EU GMP Annex 1)
8.2
Sterile Manufacturing Process Validation & Advanced Technologies
8.3
Pharmaceutical Sterilization Methods and Validation
8.4
Personnel Requirements for Aseptic and Sterile Manufacturing
8.5
Questionnaire
10 Questions
Module 8: Biological Product Manufacturing (Annex 2)
5
9.1
GMP for Biological Medicinal Products
9.2
Advanced Aseptic Processing, Viral Safety & Multi-Product Facility Control in Biological Manufacturing
9.3
GMP for Specific Biological Product Categories
9.4
Traceability & Biosafety: Donor Management, Biosafety, and Environmental Control in Biological Manufacturing
9.5
Questionnaire
10 Questions
Module 9: Radiopharmaceuticals (Annex 3)
5
10.1
GMP for Radiopharmaceuticals – Annex 3 Requirements
10.2
GMP for Radiopharmaceuticals – Annex 3 Detailed Requirements: Production & QC
10.3
Batch Release, Retention & Distribution of Radiopharmaceuticals (Annex 3)
10.4
Radiation Safety, QP Responsibilities & Health Monitoring in Radiopharmaceuticals: Personnel & Training
10.5
Questionnaire
10 Questions
Module 10: Complaints, Recalls & Self-Inspection
5
11.1
Pharmaceutical Complaint Handling – Procedure, Investigation & Regulatory Reporting
11.2
Pharmaceutical Product Recall Management – Procedure, Simulation & Coordination
11.3
GMP Self-Inspection (Internal Audit) – Program, Execution & Follow-up
11.4
Risk-Based Management of Quality Defects & Market Actions
11.5
Questionnaire
10 Questions
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