• views: 143
• date: 9 February 2025
• posted by: AD-TEAM

Continuous Improvement requirements for Pharmaceuticals

What you'll learn

Upcon completion of the course,participants will learn and equipped to Undertand the continuous improvement requirements in line with ICH Q10

The the continuous improvement is mandatory for all pharma professionals

This training will help to develop current quality KPI towards compliance

The continuous improvement is the guideline requirements and it has to be part of quality management system

Requirements

The person should be full focussed during the session.

Description

Continuous improvement is a core principle of ICH Q10, which provides a framework for a pharmaceutical quality system. It emphasizes a proactive approach to quality management, aiming to prevent issues rather than just reacting to them.Continuous improvement (CI) is a crucial aspect of the pharmaceutical industry, where even minor enhancements in processes, products, and services can significantly impact patient safety, product quality, and business outcomes.ICH Q10 works in conjunction with other ICH guidelines, such as ICH Q8 (Pharmaceutical Development) and ICH Q9 (Quality Risk Management), to promote a comprehensive approach to quality. For example, risk management principles are used to identify potential risks and prioritize improvement efforts.In essence, ICH Q10 provides a framework for organizations to:Establish a culture of continuous improvement: Where everyone is engaged in identifying and implementing improvements.Use data and knowledge to drive improvement: Making decisions based on evidence and analysis.Proactively identify and address potential issues: Preventing problems before they occur.By effectively integrating continuous improvement principles into their quality systems, pharmaceutical companies can enhance product quality, improve operational efficiency, and ensure product quality.This course is having total 6 lectures.The lectures are on introduction to process capability and process capability index, Gemba walk, 10 quality KPIs, Key questions about pharmaceutical quality system, continous improvement and brief on pharmaceutical quality system.

Overview

Section 1: Introduction

Lecture 1 Introduction - Process Capability and Process Capability Index

Lecture 2 Gemba Walk

Lecture 3 10 Quality KPIs

Lecture 4 Pharmaceutical Quality System Key Questions and Clarification

Lecture 5 Continuous Improvement

Lecture 6 Brief on Pharmaceutical Quality System

Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.




   
   
   

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