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


Instructor: Charles H Paul
Product ID: 706825

  • Duration: 90 Min
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.
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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
Instructor Profile:
Charles H Paul

Charles H Paul
President, C H Paul Consulting Inc

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.

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