The Good Manufacturing and Good Distribution Practice guidelines expect all departures from the guidelines and a company’s documented QMS to be documented via an investigation. So, what is the difference between an investigation and a good investigation, and what relevance does the Root cause analysis have to an investigation?
An effective RCA process will list all potential causes connected to the deviation/ non-conformance that has occurred. RCA can use several different tools, and some methods may suit the issue at hand better than others. The company’s RCA SOP will guide/ highlight some of the key RCA tools available to understand the root cause of the deviation/ non-conformance.
In this webinar, we will examine what constitutes a good investigation and why it matters so much that we get this right. We will also briefly examine some examples of good and bad RCAs and introduce the appropriate tools and techniques that we would employ depending on the situation/ deviation/non-conformance. Unfortunately, no one-size-fits-all tool exists, and each method has its pros and cons.
All of the above can only be achieved with the correct engagement from the key stakeholders within a company. A good investigation and effective root cause analysis cannot be achieved solely by an individual within a company. This needs to be a collaborative effort, and we will see why this is so important during this webinar.
Kay is a highly experienced consultant QP, Lead auditor and training specialist for Orion GXP Consulting. She has over 30 years of experience in senior Quality and director-level roles in sterile pharmaceutical manufacturing and biotechnology companies in Ireland. This includes a strong analytical background, having worked in QC and validation, as well as operational quality in her more recent QP and Quality systems roles. Kay assists her clients in managing their vendor portfolios and completing QP audits, releasing clinical material and instilling highly effective processes and quality culture in all her roles and assignments.
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Orion GxP Consulting provides contract QP and RP services and consultancy support to pharmaceutical manufacturing and distribution clients, such as training and expert knowledge. Orion GMP Consulting draws on the experience of our consultants and their links to the pharmaceutical industry through consulting and QP/RP roles to assist their clients in developing, managing, and continuously improving their quality systems.
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