LFU:online

·         present formal (global) requirements from Authorities on GMP

·         understanding the basic concepts of Good Manufacturing Practice

·         understanding of the structure of Quality Control, Quality Assurance and Quality Management

·         exercise in developing Standard Operating Procedures

·         understanding of the importance of documentation and training in GMP

·         exercise 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.

·         Understanding different perspectives and interpretations of guidance from Health Authorities and Industry’s point of view. 

·         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

Lehrveranstaltung mit immanentem Prüfungscharakter bestehend aus regelmäßiger Überprüfungen, Mitarbeit und Portfolio der Übungsaufgaben

Modules 1 and 2