Practical Computerized System Validation Under Scope of GAMP-05 and MHRA GMP Data Integrity

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