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Problem Solving - Root Cause Analysis in Pharma Manufacturing

Duration : 75 Minutes

Joy L. McElroy,

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more

This topic will touch on investigations whether they are post-Audit, Deviation related, Complaints, etc. It will transition into determination of RCA, the many tools used during RCA & what they really are and how to use them to greater effect.

An emphasis will be placed on a notion that there is "No such thing as Human Error", and why the possibility of Human Error should not be considered when conducting any RCA. There will also be mention of CAPA and why Training is never enough to be considered a true CAPA.

Course Objectives:

• Relevant inspection steps in relation to Root Cause
• How to use RCA to better effect
• What RCA tools really are and their place in RCA
• Why Human Error doesn't exist
• How to use your RCA to formulate better CAPAs

Why Should You Attend:

RCA is typically used as a reactive method of identifying event causes, revealing problems and solving them. Analysis is done after an event has occurred. Insights in RCA may make it useful as a pro-active method. In that event, RCA can be used to forecast or predict probable events even before they occur. While one follows the other, RCA is a completely separate process to Incident Management.

Attend this training if you are dealing with deviations, non-conformances, a high error rate, a low yield rate, a high number of RCA assessments determined to be due to Human Error. And any company that finds repeat non-conformances despite the RCA or CAPA used.

Course Outline:

• Investigations
• Root Cause Analysis
• RCA Tools
• Human error is never the sole root cause
• RCA in relation to CAPA
• Why training is not a CAPA
• How to deploy more effective CAPA based on RCA

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Regulatory
• Senior management
• Production management
• Process Automation Staff
• Manufacturing Operations Staff
• Validation Specialists
• Quality Assurance Personnel responsible for RCA/CAPA
• Quality Control and Research
• Analysts and other laboratory staff
• Regulatory Affairs
• Process engineers
• RCA/CAPA related individual
• Environmental Health Safety – Mangers, team lead and supervisors
• Product Development Analysts

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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Subject : Problem Solving - Root Cause Analysis in Pharma Manufacturing

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