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Showing posts with the label capa pharmaceutical

Laboratory non-conformances: how effective is your CAPA process?

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In case of a non-conformance in the laboratory it’s important to look deeper to figure out why the problem is occurring and fix the underlying systems and processes that caused it. Our upcoming webinar discusses the root cause analysis steps to determine the origin of a problem, developing a CAPA process and measuring its efficacy . The webinar covers the following key areas: ·          Defining the problem and examining the data ·          Identifying possible causal factors ·          Taking corrective and preventive action and verifying the effectiveness of the corrective action LEARNING OBJECTIVES Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the problem occurred in the first place. RCA assumes that systems and events are interrelated. An action in one area triggers an action in another...

CAPA: Corrective and Preventive Actions and Non-Conformance

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OVERVIEW If you only fix the symptoms   – what you see on the surface – the problem will almost certainly happen again, which will lead you to fix it, again, and again, and again. If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it. WHY SHOULD YOU ATTEND When you have a non-conformance in the laboratory, how do you approach it? Do you jump in and start treating the symptoms? Do you stop to consider whether there's actually a deeper problem that needs your attention? Learn the root cause analysis steps to determine the origin of a problem. You will learn about a specific set of steps, along with root cause analysis tools and techniques, to find the primary cause of the problem, so that you can: Determine what happened Determine why it happened Figure out what to do to reduce the likelihood that it will happen again AREAS COVERED Defining the prob...