Business Tools for Improving Organisational Performance

Compliance with Good Manufacturing Practice regulations is crucial in the pharmaceutical industry. A robust Quality Management System (QMS) is key to meeting these regulations. Pharmaceutical industries must ensure that all activities that impact the quality of medicinal products are well-documented to ensure the robustness of their QMS. Proper documentation not only provides clarity on required steps, but it also guarantees that processes can be accurately recorded and evaluated for compliance purposes.

This course provides a comprehensive overview of Risk Management and Quality Risk Management (QRM). It introduces key terminology, explains ICH Q9 in an understandable way, and covers the necessary tools to effectively assess risks. Learn how to put your risk management processes into practice with this informative program. Preliminary Hazard Analysis (PHA) is a tool used to carry out risk analysis, often in the early stages of a project to identify potential hazards and assess risk for each hazard. This module will take you through the process of using PHA as a Quality Risk Management tool.

Have you heard the terms Non-conformance and Deviations being used in GMP environment? Ever wondered why all activity seems to stop when something goes wrong in a GMP environment? This course will take you through what non-conformances and deviations are, why they are raised and monitored and how this is achieved in a GMP environment. It then moves into raising and managing CAPAs to stop the issues from recurring. Roles and responsibilities are also covered in detail to ensure a smooth functioning of the Quality system in a company.

Effective problem solving is the key to improving performance in any organisation. This course will provide you with an overview of various tools including Root Cause Analysis, 5 Whys technique, Causal Factor Charting, Cause and Effect Analysis, Process maps and Flow Charts, which are all techniques essential to Goods Manufacturing Practice (GMP).