Data Integrity is currently the major concern with both the FDA and European Regulatory Agencies. Many FDA warning letters and EU GMP inspections have highlighted major data integrity failures at companies globally. Laboratory testing data is a main source for the regulatory agencies to assess the transparency of a pharmaceutical company. The extent of quality of a product is determined based on this lab data. Unfortunately, the main ingredient of recent warning letters is a breach of data integrity in the QC Laboratory.
Areas Covered in the Session :
- Regulatory Agencies focus on QC Laboratories
- Main Activities in Quality Control
- Difference between GLP and GMP
- Data Integrity Issues in the Laboratories
- Establishing the controls to prevent Data Integrity
- Data Integrity and Human Errors
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Analytical Development Laboratories
- Manufacturing Departments
- Engineering Departments
- Documentation Departments
ICT112
