Course Overview 

When deviations occur, the strength of your investigation process directly impacts product safety, regulatory outcomes, and your company’s reputation. CASTL’s Deviation Handling and GMP Investigations course equips your team with the mindset, methods, and tools to manage GMP deviations the way regulators expect: structured, compliant, and root-cause driven. 

Through a realistic, scenario-based format, participants are immersed in a real-life deviation case and work collaboratively to analyze root causes and apply tools like 5 Whys and Ishikawa diagrams. The training encourages critical thinking, cross-functional discussion, and the direct application of GMP principles in a high-stakes context. 

Why It’s Essential 

Poorly executed investigations are among the top findings in regulatory inspections, and they can derail production timelines, trigger compliance observations, and damage trust with regulators and partners. Here’s why your team cannot afford to miss this: 

• Protect regulatory standing: Train your team to produce clear, complete, and defensible investigation reports that stand up to audit scrutiny. 

• Strengthen root cause analysis: Prevent recurrence by equipping your employees with the tools and judgment to identify and address underlying causes, not just symptoms. 

• Speed up recovery: Improve efficiency by reducing investigation time and avoiding costly rework. 

• Foster a quality-first culture: Encourage cross-functional problem solving and ownership of deviations at every level of your organization. 

This course turns a common operational vulnerability into a competitive advantage. 

What Your Team Will Learn 

Participants will develop hands-on competence in: 

• Understanding the role and impact of investigations in a GMP/GxP environment. 

• Navigating the investigation lifecycle: detection, containment, analysis, action, and closure. 

• Using proven root cause analysis tools (5 Whys, Fishbone diagram) to find and fix issues at their source. 

• Designing and documenting effective CAPAs (Corrective and Preventive Actions). 

• Writing audit-ready, structured, and evidence-based investigation reports. 

• Practicing problem-solving through real-world GMP scenarios and group dialogue. 

Who Should Attend 

This course is ideal for regulated manufacturers committed to raising the bar on deviation handling, investigation quality, and audit readiness.

Recommended for: 

• New hires who need to build early GMP investigation fluency 

• Quality Assurance (QA) professionals who lead or support deviation resolution 

• Production operators and supervisors who initiate or participate in investigations 

• Maintenance and qualification engineers involved in root cause analysis 

• Quality Control (QC) staff supporting investigations and CAPA development 

If your facility touches GMP-regulated processes, your team needs this training to operate with discipline, credibility, and compliance confidence.