LFU:online

Students will understand the most importnat principles of GMP.

• Regulatory Overview: Legal bases, Inspections, MRAs, Regional Differences
• Good Manufacturing Practice: requirements and historical background, specific requirements regarding Clinical Trials
• Quality Basics: Quality Control, Quality Assurance and Quality Management,
• Development of Standard Operating Procedures
• Principles for documentation in GMP
• Principles for training in GMP
• Quality Risk Management
• Qualification and Validation
• Interactive Case Study: students will e.g. work on practical examples with exercises in developing Standard Operating Procedures and in Quality Risk Management incl. the use of risk analysis tools, understanding of Qualification and Validation, a thorough understanding of bringing guidelines and recommendations into workflows and GMP procedures within an industry analytical laboratory, understanding and translating Data Integrity principles and incorporation of such in daily routine laboratory operational workflows and procedures and understanding different perspectives and interpretations of guidance from Health Authorities and Industry’s point of view. 

combination of lecture and interactive exercises

active participation in lectures and exercises demonstrating understanding of theoretical principles and critical reasoning

Modules 1 and 2