The Advanced Root Cause Analysis for Pharmaceuticals Masterclass is a comprehensive and transformative course designed to equip professionals with the skills and knowledge needed to identify the underlying causes of problems and drive business improvement. Over two days, participants will learn a structured approach to RCA, enabling them to uncover systemic causes rather than solely attributing issues to human error.
On Day 1, the training covers the essential steps of RCA, including problem definition, problem history, possible causes, linking to root causes, and preventive/mitigating actions. Participants will learn how to define problems accurately, analyze historical data, identify root causes, and implement preventive actions. They will also gain insights into challenges associated with RCA, such as information availability, multiple causes, and investigator knowledge.
Day 2 focuses on RCA tools, providing participants with a range of techniques to enhance problem-solving capabilities. Tools covered include the Five "Why?"s method, brainstorming, Failure Mode and Effects Analysis (FMEA), fault tree analysis, causal factor tree analysis, Ishikawa diagrams (The Six Ms), barrier analysis, Pareto analysis, change analysis, process maps, and the Is/is not technique. Through practical exercises and case studies, participants will gain proficiency in using these tools to uncover complex issues and drive sustainable improvements.
By the end of the training, participants will possess a comprehensive toolkit of RCA methodologies and techniques. They will be equipped to drive continuous improvement, ensure regulatory compliance, and unlock operational excellence in the pharmaceutical industry.
Learn a structured approach to RCA that enables you to perform thorough and effective investigations. Gain the skills to uncover the true root causes of problems, deviations, and non-conformances, leading to more accurate and impactful corrective actions.
Recognize that problems often have multiple causes and that a single cause can contribute to multiple issues. Develop the ability to identify and address underlying systemic causes rather than focusing solely on surface-level symptoms.
Be familiar with current regulatory expectations for RCA in the pharmaceutical industry. Ensure compliance and alignment with regulatory requirements, enhancing your organization's reputation and credibility.
Appreciate the variety of root cause analysis tools available and gain the knowledge to select the appropriate tool for investigating medium-complexity or highly complex problems. Expand your toolkit and enhance your problem-solving capabilities.
Acquire the skills to drive significant business improvement through RCA. By addressing root causes rather than symptoms, you can implement systemic solutions, improve quality, enhance operational efficiency, and boost overall business performance.
Through hands-on exercises, case studies, and real-life examples, you will gain practical expertise in applying RCA methodologies and tools. Build confidence in your problem-solving abilities and develop a systematic approach to investigations that yields tangible results.
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s AnalyticalDivision and led a working group on continuing professional development until July 2016.
He has worked at a senior level in several companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes, including stability evaluation.
In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved managing the analytical and stability aspects of early and late-stage pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, root cause analysis and stability/stress studies.
