The GxP (GMP, GLP, GDP) Data Integrity, Quality Metrics and FDA Inspections 2017 is dedicated to complete insight to Indian Pharma quality and data integrity as well as preparation for FDA inspections.
Topics
- Data integrity issues and compliance in Non-QC laboratory
- Data integrity issues, reasons and compliance in QC laboratory
- CFR Part 11 and EU annex 11 requirements and examples
- CGMP Regulations and Guidance
- Quality metrics and FDA expectations
- Warning letters, 483s on data integrity and how to resolve those
- Laboratory OOS and incidences
- Good documentation Practices
- How to prepare for and face Regulatory (FDA,EU, etc..) Inspections
- QMS and Incident Management in cGLP environment
Who should Attend
Attendees with responsibilities in:
- Quality Control Laboratories Companies
- Pharmaceutical Development Companies
- Quality Departments of Finished Product Manufacturers
- Quality Departments of API Manufacturers
- Clinical Research Organisations
- Contract Laboratories
