Course Overview:

Risk management is now a central part of compliance and decision-making in pharmaceutical manufacturing. This one-day Pharmaceutical Risk Management Training course is designed to help individuals and teams understand how risk-based thinking can be applied across operations, from production and packaging to validation and quality control.

Whether you’re completely new to pharmaceutical risk management or want to build on existing knowledge, the course offers a practical introduction to the tools, techniques, and regulatory expectations shaping the industry today.

It also gives you hands-on experience using structured approaches such as FMEA, HACCP, and the GAMP® methodology, all guided by current standards including ICH Q9 and Annex 20.

Who Should Attend?

• QA and validation professionals
  

• Engineers and production managers
  

• Compliance teams and project leaders
  

• Anyone responsible for quality decisions or risk assessments in pharma environments

What You’ll Learn

• Why risk management is critical in today’s regulatory environment
  

• How flexible regulatory frameworks allow companies to take the right actions for their processes
  

• How to interpret and apply ICH Q9 and Annex 20 guidance
  

• EU and FDA expectations for risk-based approaches and decision-making
  

• What successful risk management looks like, roles, documentation, leadership, and common pitfalls
  

• The relationship between human error and risk
  

• A comparison of key tools used in pharmaceutical risk management:
  

  • HACCP (Hazard Analysis and Critical Control Points)
    

  • FMEA (Failure Modes and Effects Analysis)
    

  • GAMP® (Good Automated Manufacturing Practice)

Practical Case Studies

Apply your learning through three real-world risk scenarios:

• Use HACCP to identify critical control points in a production process
  

• Apply FMEA to assess hazards and define corrective actions in a manufacturing environment
  

• Use the GAMP® approach to determine appropriate qualification testing in a packaging validation project
  

These exercises are designed to help bridge the gap between theory and real-world application, giving you confidence in how to apply risk management in your role.

Why This Course Is Valuable

• Breaks down complex guidance into practical steps
  

• Equips your team to make better decisions, backed by regulatory expectations
  

• Helps build a stronger risk culture across your site
  

• Ideal for teams involved in validation, quality assurance, compliance, and operations
  

• Supports a consistent, documented, and measurable approach to managing risk