Recently the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE) has signed a Memorandum of Understanding (MOU) confirming their plans to continue to advance practical approaches for quality culture. The first product of this collaboration is the Root Cause Analysis (RCA) guide. The organizations selected Root Cause Analysis as the first topic in this undertaking as root cause analysis forms a significant part of any organization’s continuous improvement program.

Root Cause Analysis (RCA) is a defined process that seeks to explore all of the possible factors associated with an incident by asking what happened, why it happened and what can be done to prevent it from happening again. In other words, by getting to the bottom of an incident at the root, the action can be taken to fix it permanently. RCA, however, continues to be a topic observed by regulators as something the pharmaceutical industry does poorly. The most common failings include poor investigative techniques, not reaching true root cause, which then causing ineffective Corrective and Preventive Action (CAPA).

1. The training course will provide best practices, tools and techniques for RCA that have shown to be effective for the pharmaceutical industry, strategies for assessing criticality and reaction to events/problems, guidance for implementing effective CAPA system.
2. The course will include some background on the tools and techniques that are effective in conducting better root cause investigation and CAPA. The examples and their use will be provided as an exercise where attendees will be able to participate in a simulated incident and investigation, putting these tools and techniques into practice.
3. In addition, attendees will hear from Thai FDAs to give insight on their inspections and collaboration efforts regarding RCA and CAPA concerns. The actual industry example will be raised with their advices on how to establish a reliable and sustainable quality system in order to meet the regulatory requirements.

Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA), Management Refresh Quality (QRM)

HOW TO REGISTER 1. Online Registration Browse website https://www.ispeth.org/ISPEThailandEvent4-2019, fill-in delegate details and click submit 2. Confirmation ISPE staff will confirm your registration status via email. If not receive email within 2 working days after submitted the form, please contact our staff. 3. Payment Make a payment to reserve your seats and capture/ scan transferred evidents i.e. payslip to email REGISTER@ISPETH.ORG REGISTRATION CLOSES ON 9 December 2019 OR WHEN ALL SEATS ARE FULLY RESERVED. FIND OUT MORE INFO & CONTACT US: WWW.ISPETH.ORG EMAIL: REGISTER@ISPETH.ORG T: +6688-090-4664