Dublin, Nov. 13, 2026 (GLOBE NEWSWIRE) -- "Data-Driven Process Control: Statistical Process Control (SPC) Tools for Quality, Stability, and Performance (Feb 24th - Feb 25th, 2027)" has been added to ResearchAndMarkets.com's offering.
Modern regulators expect life science manufacturers to demonstrate that manufacturing processes remain in a continuous state of control throughout the product lifecycle - not only during initial process validation. The United States Food and Drug Administration, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, and World Health Organization place significant emphasis on process monitoring, statistical trending, documented review, and proactive quality management.
This two-day Statistical Process Control training course helps life science professionals develop the practical skills required to monitor, assess, and improve manufacturing process performance. It is suitable for delegates without a formal statistics background, with concepts presented from first principles through visual interpretation, structured exercises, and step-by-step manufacturing examples.
The course connects Statistical Process Control with continued and ongoing process verification requirements across pharmaceutical, biopharmaceutical, and medical device manufacturing. The training aligns with key international guidance and quality standards, including:
- United States Food and Drug Administration Process Validation Guidance, including Stage 3: Continued Process Verification
- European Union Good Manufacturing Practice Annex 15 requirements for ongoing process monitoring and trend review
- International Council for Harmonisation guidance on Pharmaceutical Quality Systems and Product Quality Monitoring System expectations
- World Health Organization expectations for quality monitoring and manufacturing performance control
- International medical device quality management system requirements, including process monitoring and critical-to-quality trending
Delegates will learn how to select, create, and interpret appropriate control charts for manufacturing data. The course addresses the identification of meaningful process shifts, the assessment of normal and abnormal variation, and the establishment of investigation triggers supported by clear decision-making criteria. Participants will also examine how Statistical Process Control data can contribute to effective deviation management, corrective and preventive action, product quality review, management review, and continual improvement.
Interactive learning activities are included throughout the programme and are based on realistic inspection-style scenarios. These practical sessions help delegates evaluate process performance, review trend evidence, identify signals requiring escalation, and document conclusions in a manner that supports regulatory inspection readiness.
The course also considers the governance required for an effective process monitoring programme. Delegates will explore roles and responsibilities, data review frequency, escalation pathways, investigation requirements, reporting practices, and the documentation needed to demonstrate sustained process control. This structured approach supports consistent decision-making and enables organisations to respond confidently to inspector questions, including:
- 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 completing the course, delegates will be equipped to apply Statistical Process Control as an integrated compliance and continuous improvement tool. The knowledge gained will support stronger product quality assurance, more effective process monitoring, improved operational performance, and robust evidence of ongoing process verification throughout the manufacturing lifecycle.
CPD Hours: 12
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.
Key Topics Covered:
- Day 1
- Regulatory foundations for SPC
- SPC fundamentals in manufacturing processes
- Process capability and practical statistical interpretation
- Governance of continued process verification and data review
- Day 2
- Implementing SPC in Production
- Modern monitoring tools for process control
- Current challenges and industry trends
- Workshop: applying SPC to real cases
Speakers
Paul Palmer
Paul R Palmer is a Director / Pharmaceutical Consultantanda practicing EU / UK Qualified Person.Hehas over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
Farah Nadeem
Farah Nadeem is an Operations Manager at Paul R. Palmer Limited/ Pharmaceutical Consultant and a Trainee Qualified Person. Farah is a Pharmacist and recognised QA expert and has over 20 years of experience in the Pharmaceutical industry in the development, manufacture and supply of medicinal products.
Throughout her career, she has held various quality assurance roles and actively pursued new opportunities to expand her knowledge and expertise. As a result, she has gained a comprehensive understanding of manufacturing, storage, and distribution processes, as well as the facilities and services that support them. Involved in documentation management: writes, reviews, and audits SOPs and QMS implementations. Assists companies in meeting regulatory requirements.
In her current role as a QA Operations Manager for a Pharmaceutical Consultant Company, Farah Nadeem provides various solutions, including assistance in obtaining the first MIA(IMP) and MIA licenses, as well as preparation and hosting for regulatory inspections. Her work involves collaborating with Paul Palmer to offer services such as QP declarations for API manufacturers, regulatory inspection hosting, commercial and clinical batch release, compliance audits, and coaching and training in GxP.
For more information about this training visit https://www.researchandmarkets.com/r/bal1po
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