Risk Assessment in GMP Environments

Level

Introductory

Format

On-site, practical, including essential theory

Duration

Half-day

Cost

$543

Overview

Regulatory authorities expect organizations to integrate risk management throughout all aspects of GMP operations. This course equips participants with the tools and mindset needed to proactively identify, assess, and mitigate quality 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), they gain practical skills that can be applied immediately to improve decision making and reduce compliance vulnerabilities.

Why It’s Essential

Many compliance failures are not due to lack of knowledge, but rather a lack of structured risk management. This course enables participants to:

• Anticipate and prevent issues: Identify and document risks before they turn into costly deviations

• Meet regulatory expectations: Ensure alignment with global guidelines, including ICH Q9 and EU GMP Annex 1

• Streamline environmental monitoring: Use risk-based tools to design smart and effective sampling plans

• Build a culture of quality: Embed risk awareness and structured problem solving across departments

This course builds the mindset your team needs to resolve deviations efficiently and effectively.

Learning Objectives

• Understand the core principles of quality risk management in GMP (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. 

Who Should Attend

This course is ideal for teams working in GMP environments who want to integrate risk management more effectively into their daily processes and decision-making.

• New industry hires onboarding into GMP roles 

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

• Production operators, supervisors or subject matter experts (SMEs) 

• Quality control (QC) personnel, particularly those working on Environmental Monitoring 

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

Participants who successfully complete a theoretical assessment will receive a certificate of completion.