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