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Quality systems fail when corrective action stops at fixing symptoms instead of preventing recurrence. Many CAPA processes focus on closing deviations, but without clear problem definition and true root cause identification, the same issues continue to reappear. In regulated environments, this not only weakens compliance but also creates operational inefficiency, inspection risk, and unnecessary rework.
This workshop introduces a Lean-based approach to CAPA that moves beyond surface-level explanations such as “human error” and focuses on process design, workflow clarity, and systemic improvement. Participants will learn how Lean principles can be applied to identify non-value-added activities, define problems accurately, map real operational processes, and develop corrective actions that address root causes rather than symptoms. The emphasis is on building CAPA systems that strengthen both regulatory compliance and day-to-day operational performance.
The session is designed for quality assurance professionals, internal auditors, regulatory compliance teams, and professionals working in pharmaceutical, biotechnology, and medical device environments who are responsible for CAPA systems, inspections, and quality oversight. It is equally valuable for those seeking to strengthen their understanding of Lean problem-solving, process improvement, and sustainable quality system design.
The workshop is led by Terry Pilkey, a Chartered Chemist with over 30 years of experience in the pharmaceutical industry, including more than 13 years at Health Canada within the Health Product Branch Inspectorate and current leadership as Director of QA/QC at Experchem Laboratories Inc. Her experience spans GMP inspections, compliance oversight, auditing, and laboratory quality systems, bringing both regulatory and operational perspectives into applied learning.
Register by January 30 to receive an early bird discount of 20 percent. Use code SAVE20 at registration. | 
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