quality-management-system

Quality Management System

Live Webinar

  • 120 minutes

QMS is a comprehensive approach for an organization or company to implement and maintain Good Laboratory Practice (GLP). QMS covers the structure, roles, policies, and procedures throughout the complying group. QMS is a system that covers all areas of the organization. Many of these are outside of the laboratory, so QMS defines management and policy requirements to make certain that everything supports the laboratory so that its results are of the needed high quality.Early Quality Management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labour inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signalling of problems via a continual Improvement cycle.

Join this session with expert speaker John Fetzer, where he will discuss about Quality management and its importance for an Industry. Also, he will discuss about the different Quality management elements and processes. This webinar will give you a brief idea about Quality Audits and Seven tools of Quality management.

Session Highlights:

This webinar will cover the following topics.

  • GLP Regulations

  • Quality Management System (QMS)

  • Definition

  • Principles

  • Purpose

  • Function

  • Elements

  • Quality Policy

  • Quality Objectives

  • Quality Manual

  • GLP SOPs

  • Plan, Do, Check, Act Cycle

  • GAP Analysis

  • QMS Implementation Steps

  • Process Control and Optimization Theory

  • Process Criteria

  • Quality Audit

  • Proposed Rule Summary

  • Cost of QMS

  • GLP QMS GAP Analysis Checklist

  • Sample GLP QMS Table of Contents

  • Example of Process Flow & Criteria

  • Required GLP SOPs

  • SOP Template

  • Seven Tools of Quality Management

  • Terms: Define & Differentiate

Why You Should Attend:

Quality is a crucial parameter which differentiates an organization from its competitors. The proposed modifications to the US FDA GLP are major, putting it in alignment with the GLP version used by the US EPA and US OSHA, as well as with ISO 17025. There are major changes in the requirements for documents, management responsibilities, verifications, archiving, and other areas. Quality management tools ensure changes in the systems and processes which eventually result in superior quality products and services.Quality Management ensures increased revenues and higher productivity for the organization.

Who Should Attend:

  • Management at all levels of any company that has a GLP operation

  • Laboratory chemists and other workers

  • Quality in officers, managers all support areas that a laboratory uses.

  • It is aimed at managers, supervisors, and other professional staff in companies where FDA GLP must be implemented or is already in place.


*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it at your convenience.

John C. Fetzer

John C. Fetzer

John C. Fetzer holds a PhD in analytical chemistry. He has developed methods in liquid chromatography, UV and fluorescence spectrometries, and in the determining the solubility and partition coefficients of chemicals. He supervised a GLP compliant laboratory for over a decade and has taught numerous short courses on compliance.

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