Data-Driven Process Control: Statistical Process Control (SPC) Tools for Quality, Stability, and Performance Training Course

Course overveiw

Modern regulators increasingly expect manufacturers to demonstrate that processes remain in a continuous state of control throughout the full product lifecycle - not only during initial validation. Authorities such as the United States Food and Drug Administration, the European Medicines Agency, the Medicines and Healthcare products Regulatory Agency, and the World Health Organization now place strong emphasis on effective monitoring, trending, and proactive management of manufacturing processes.

This two-day training course is designed for life science professionals who need to apply Statistical Process Control confidently, even if they do not have a statistics background. All concepts are taught from first principles using clear explanations, visual interpretation, and step-by-step manufacturing examples.

The course links Statistical Process Control to continued and ongoing process verification expectations and aligns learning with international guidance and standards including:

• The United States Food and Drug Administration Process Validation Guidance (Stage 3: Continued Process Verification)
• European Union Good Manufacturing Practice Annex 15 requirements for ongoing monitoring and trend review
• International Council for Harmonisation guideline on Pharmaceutical Quality Systems (Product Quality Monitoring System expectations)
• World Health Organization expectations for quality monitoring and performance control
• International standard for medical device manufacturing quality management systems, including process monitoring and critical-to-quality trending

Delegates will learn how to create and interpret control charts, detect meaningful process shifts, distinguish normal variation from abnormal variation, and build a structured governance system that supports inspection readiness and continual improvement.

Every session includes interactive learning activities designed around inspection-style scenarios. This ensures delegates understand not only the tools, but also how to build evidence that can confidently answer inspector questions such as:

• How do you know your process remains in control?
• Where is your trend review evidence?
• What triggers an investigation and how is this documented?

By the end of the course, delegates will be equipped to apply Statistical Process Control as both a compliance tool and a continuous improvement tool, supporting stronger product quality assurance and improved operational performance.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.

Benefits of attending

• Understand what regulators expect for Statistical Process Control and continued process verification evidence
• Discover how to present control and trend monitoring evidence confidently during inspections
• Improve decision-making so investigations are triggered only when justified
• Understand how to choose the correct control chart for different manufacturing data types
• Learn to interpret charts correctly and identify early warning signs of process drift
• Study how to detect true abnormal signals while avoiding false alerts
• Gain a practical view of predictive analytics and future monitoring trends without requiring advanced mathematical knowledge
• Learn how Statistical Process Control supports maintenance of a validated state and how trending data feeds into quality review systems and continual improvement

Who should attend

This course is ideal for professionals involved in manufacturing, quality oversight, process monitoring, validation, or regulatory compliance across pharma, biologics, sterile manufacturing, and medical devices, including:

• Pharmaceutical manufacturing and operations: process engineers, production managers, supervisors
• Medical device manufacturing teams: ISO 13485 roles responsible for CTQ (Critical-To-Quality) monitoring, capability, and validation maintenance
• Quality assurance/quality control: QA specialists, QC analysts, data reviewers
• Validation and technical operations: Continued Process Verification (CPV) owners, validation managers, tech transfer leads
• Regulatory/compliance: Risk Assessment (RA) and compliance professionals 

No statistics knowledge required - all concepts are taught with practical visuals and guided interpretation.

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