Course Overview 

Regulatory authorities expect companies to embed risk management into every level of their GMP operations. CASTL’s Risk Assessment in GMP Environments course equips your team with the tools and mindset to proactively identify, evaluate, and control operational risks. 

Through an engaging, interactive workshop, participants learn how to conduct effective risk assessments, with a particular focus on environmental monitoring (EM) and alignment with ICH Q9 and EU GMP Annex 1 expectations. Using tools like the Risk Matrix and Failure Mode and Effects Analysis (FMEA), your employees gain practical skills they can apply immediately to improve decision-making and reduce compliance vulnerabilities. 

Why It’s Essential 

Many compliance failures are not due to lack of knowledge—but lack of structured risk thinking. Here's why this course is indispensable for your operations: 

• Anticipate and Prevent Issues: Empower your team to identify risks before they turn into costly deviations. 

• Meet and Exceed Regulatory Expectations: Ensure alignment with global guidelines, including ICH Q9 and EU GMP Annex 1. 

• Streamline Environmental Monitoring: Equip personnel with risk-based tools to design smarter, more compliant sampling plans. 

• Promote a Culture of Quality: Embed risk awareness and structured problem-solving across departments. 

With regulators increasingly emphasizing risk-based approaches, companies that fail to train staff accordingly risk falling behind—or worse, facing audits unprepared. 

What Your Team Will Learn 

Participants will leave this workshop able to: 

• Understand the core principles of GMP risk management (ICH Q9, Annex 1). 

• Define and apply key concepts like hazard, severity, likelihood, and detection. 

• Use Risk Matrices and FMEA to structure decision-making. 

• Conduct risk assessments focused on Environmental Monitoring (EM), including risk-based sampling strategies. 

• Document risk activities to meet regulatory and audit standards. 

• Drive better cross-functional communication around risk control. 

This is more than a training—it's a mindset shift toward operational excellence. 

Who Should Attend 

This course is ideal for teams in regulated industries looking to embed risk management early and often in their workflows: 

• New industry hires needing foundational knowledge 

• Quality Assurance (QA) professionals involved in risk analysis and documentation 

• Production personnel, including operators and supervisors 

• Quality Control (QC) staff working with EM and product testing 

• Any team members responsible for investigations, CAPAs, or process improvements 

If your team touches compliance, quality, or production, you need this course.