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Training & Seminars

Pharmaceutical CAPA and Problem Solving (7 – 9 May 2018) – 3 day Course

Dari Isnin, 07 Mei 2018 -  8:00
Ke Rabu, 09 Mei 2018 -  5:00

Aim: To learn about how to use the CAPA system not only to satisfy regulatory requirements but also to implement a closed loop problem solving system to help minimise quality issues and improve compliance. To help identify regulatory requirements and expectations related to failure investigation, root cause analysis (RCA) and CAPA. A brief discussion on controls such as pharmacovigilance for drug products, FSCA and AE reporting for medical devices.

Day 1 AM ► Defining CAPA

PM ► Overview and Systematic application of the CAPA system as it applies to quality audits

Day 2 AM ► Relationships between CAPA and risk assessment/management

PM ► Risk assessment/management as it applies to audit observations

Day 3 AM ► Application of CAPA to audit observation deficiencie

PM ► How to perform Root Cause Analysis for a compliant CAPA