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

DUBLIN--(BUSINESS WIRE)--The "Pharmaceutical Quality Management - Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible" webinar has been added to's offering.

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.

Who Should Attend:

  • 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

Key Topics Covered:

  • 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

For more information about this webinar visit

Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

Editor Details

  • Company:
    • Businesswire
Last Updated: 04-Jul-2022