Training & seminars
Pharmaceutical CAPA and Problem Solving
26 September 2016
Where
the Boulevard St Giles Premier Hotel<br />Mid Valley City<br />Lingkaran Syed Putra,<br />59200 Kuala Lumpur, Malaysia
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 and overview and systematic application of the CAPA as it applies to quality audits
PM ► Relationship between CAPA and risk assessment/management
Day 2
AM ► Risk assessment/management as it applies to audit observations and schedules
PM ► Application of CAPA to audit observation deficiencies and failure investigations
Day 3
AM ► Pharmacovigilance for drug products, product complaints and recalls
PM ► Field corrective and Safety Actions (FSCA)/Adverse Event (AE) Reporting For medical devices – what, when, why and how?
Download the brochure and registration form.