课程概览
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
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
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.
Day 1
课程大纲
Day 2
Regulatory foundations for SPC
Continued process verification expectations from global regulators
EU requirements for ongoing verification and trend review
PQS expectations for product quality monitoring
Medical device process monitoring requirements
Typical inspection findings linked to weak trend review or poor governance
SPC fundamentals in manufacturing processes
Understanding variation and state of control
Data quality and measurement readiness
Variables data and attributes data
Control chart selection principles
Examples from pharmaceutical and medical device manufacturing
Exercise: chart selection
Process capability and practical statistical interpretation
Establishing baselines and subgrouping logic
Capability indices for pharmaceutical and device processes
Interpretation of capability results and risk implications
Rules for detecting out-of-control signals
Common mistakes that create false alarms
Exercise: workshop with capability analysis and chart interpretation
Governance of continued process verification and data review
Selection of critical process parameters and quality attributes
Data review systems
Trend identification and response
Exercise: workshop reviewing and improving a mock continued process verification report
Implementing SPC in Production
Applying Statistical Process Control to high-risk process steps
Integrating control monitoring into standard operating procedures
Defining reactions: monitor, investigate, escalate
Using control signals to support deviation handling and corrective and preventive actions
Exercise: simulation exercise (teams interpret signals)
Modern monitoring tools for process control
Monitoring multiple process parameters together (practical introduction)
Process Analytical Technology monitoring principles
Digital dashboards and automated alert systems
Practical overview of predictive monitoring concepts
Interactive: interpretation quiz using a dashboard-style dataset
Current challenges and industry trends
Common inspection findings linked to poor Statistical Process Control governance
Data integrity risks in trend systems and reporting tools
Avoiding spreadsheet-driven compliance failures
Medical device monitoring expectations for critical-to-quality characteristics
How regulators expect decisions to be justified and documented
Interactive: build an inspection-ready evidence pack in teams
Workshop: applying SPC to real cases
Interactive session with examples and discussions.
Topics (case scenarios):
Oral solid dose manufacturing trend shift
Sterile manufacturing attribute drift
Biological process parameter shift
Medical device critical-to-quality trend and capability problem
Interactive: team presentation plus mock inspector questions and feedback