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

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

Who Will Benefit:

• Quality Assurance Personnel
• Quality Control Personnel
• Supply Chain and Logistics Managers
• Regulatory Affairs Professionals
• Process Development Scientists and Management
• Manufacturing Management and Scientists
• Auditors
• R&D Management
• Risk Management Specialists
• Manufacturing Directors and Supervisors
• Validation Specialists, Scientists