Clinical Compliance 2012 - Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues

This webinar will help you understand the current requirements for raw material management with tips about practical implementation. It covers FDA’s expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of material supplied, expectations from quality control and documentation processes, and training requirements, with case studies.

Almost all FDA findings during GMP inspections include raw material related issues and most FDA warning letters to GMP facilities cite violations in raw material management. FDA's GMP inspectors pay special attention to the way raw materials are sourced, handled, controlled, used, and accounted for at a given facility.

Areas Covered:
- FDA requirements for raw material management at GMP facilities
- Common risk management practices
- Vendor selection and validation requirements
- Product specific raw material issues: chemical, biologic and botanical raw materials
- Suggested quality control measures
- FDA’s common findings and possible resolutions
- Trends in FDA inspection of raw material processes
- Regional and multinational raw material providers
- Raw material risk management in the global setting