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

This instructor-led live webinar will discuss the established approach of Pharmaceutical Quality Management as it relates to the relationship between risk management and the pharmaceutical regulations that govern the business.

Why Should You Attend:

The use of quality risk management in pharmaceutical operations does not preclude the requirement for a company’s compliance to all applicable regulations. The key is knowing how this process can be best applied to assure compliance and the prioritization and mitigation of identified risks and not as a decision-making process to determine the applicable regulations that must be complied with. This webinar will discuss that pathway.

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