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Training Overview

Root cause analysis (RCA) is a regulatory requirement for regulated companies in the
pharmaceutical industry. According to ICH Q10, companies should have “a system for
implementing corrective actions and preventive actions resulting from the investigation
of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory
inspections and findings, and trends from process performance and product quality
monitoring”. The guidance requires a structured approach to the investigation process with
the aim of determining the root cause. In addition to regulatory compliance, RCA can be
a valuable tool for business and quality improvement, and often leads to better product
and process understanding. This two-day course sets out a logical approach to RCA that
helps the investigator(s) define the problem, assign correct or likely root cause(s), and to
implement corrective actions and preventive actions (CAPA) that address root cause. Day 1
of the course describes the RCA process, starting with problem definition and investigation,
and finishing with root cause assignment and implementation of CAPAs. The second day
focuses on tools that are helpful in root cause identification and in the evaluation of
proposed CAPAs.

Learning outcomes:

• The definition of root cause
• The benefits of root cause analysis
• Key steps in root cause analysis
• How to apply the principles of quality risk management to root cause
• The importance of good problem definition
• How to write an effective problem statement
• How to use knowledge of problem history to identify possible causes
• How to identify likely root causes
• The characteristics of effective corrective actions and preventive actions
• The limitations of root cause analysis
• How to apply common root cause analysis and risk assessment tools to root
cause analysis


Dr Mark Powell
Dr Mark Powell

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