2022 - Pharmaceutical Quality Management - Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible

Areas Covered in the Webinar:
Quality and risk management defined
The QRM process
The core principles and common practices of quality management
The risk assessment approach
Risk management tools - hazard analysis (PHA), risk evaluation and mitigation (REM), hazard analysis critical control point (HACCP), and FMEA
Integrating QRM into your quality system
The critical QRM regulations and guidance documents that apply to pharmaceutical manufacturing
Regulations that will be Covered:
FDA Guidance for Industry – Q8 Pharmaceutical Development
FDA Guidance for Industry – Q9 Quality Risk Management
FDA Guidance for Industry – Q10 Pharmaceutical Quality System