• 27 May, 2021

Portfolio Description

Participative-learning Approach  To Practical Application of EU-GMP

#1: Lecture :    Preparatory Actions for PIC/S GMP

#2: Lecture :      Regulatory Inspection based on EU GMP Guide

#3: Workshop : Establishing foreign matter contamination prevention measures, learning from product recall case studies.

#4: Workshop : Product recall example due to error in packaging and labeling

#1: Lecture :      GMP inspection and  Marketing Authorization in Europe

#2: Workshop : Typical Observations in Deviation and OOS handling

#3: Workshop : Key points of Practical considerations and Control method for water of pharmaceutical use

#4: Workshop : Key points and Practical Considerations about Computer Validation and  Data Integrity for GMP Data

#5: Workshop : Data Integrity compliant QC Laboratory Control