In this seminar;
- Explaining FDA, EU Annex 11 requirements under GAMP-05’s scope.
- Describing Computerized Systems Validation’s requirements with case studies.
- Creating a plan to update Computerized Systems Validation and electronic raw data management procedures and instructions.
- Understanding expectations of Health Ministries (MoH, FDA, MHRA and EU).
- Impact of data integrity and data management on computerized systems validation based on ICH Q9 quality risk management approach will be explained in this seminar