Implementing a GxP Quality Management System-Outrageous Ideas For Your GxP Quality Management System

In a scenario of competitive markets, informed customers and rapidly changing business environments, organizations are realizing that Quality and Quality Management Systems (QMS) are an indispensable tool by which they can stay ahead. This is all the more pronounced when it comes to pharmaceutical companies, since their products are delivered directly to the human body.

The benefits of a clear and effective QMS are varied. They are proven, documented and quantifiable. The most prominent benefits a successful QMS brings about are the maximization of customer satisfaction, a lowering of costs, and an increase in agility. It fortifies an organization’s quality policy, objectives and core values at every level, and integrates iterative process improvement mechanism into it. This integration engenders alignment with FDA regulations and allows the organization to optimize its product and support processes.

A GxP QMS is a process whose implementation requires the competency, commitment, coordination and confidence of all production and support staff and management. Understanding some fundamental concepts, benefits and barriers will increase the likelihood of effective GxP QMS development and deployment, compliance with quality drivers and increased customer satisfaction.

A thorough understanding of these concepts will be imparted at a valuable webinar that Compliance4All, a leading provider of professional training, is organizing on July 26. William D. Fox, a quality management professional, will be the expert at this 90-minute session, which will impart Senior Managers, Managers & Supervisors, Process Owners, Departmental Heads, QA, QC and Continuous Improvement Managers & Staff, Quality Consultants, Regulatory and Compliance Managers, and Change Control/Documentation Staff with tremendous insights into all aspects of a GxP QMS.

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For an organization to implement a QMS, all its production and support staff and management need to have competency, commitment, coordination and confidence of everyone involved in it. The deeper their grasp of a few fundamental QMS design and implementation concepts, benefits and barriers; the greater the chances of an effective deployment.

Quality Management Systems vary across and within industries and organizations. Some of the parameters that go into making each organization’s QMS unique are Quality drivers such as industry standards, regulations and best practices. Each company can use these to create a tailored design and implementation strategy that implements the organization’s specific goals, processes and customers.

QMS is such a core part of an organization’s Quality Policy that it affects every aspect of the performance. An unsuccessfully implemented QMS not only dwindles the organization’s resources; it could take it further away from its Quality goals.

At this webinar, the participants will gain solid understanding of all these aspects of a QMS, which will reap for them all the benefits it brings. William will cover the following areas at this session:

About the expert: William D. Fox brings a background in clinical research and quality assurance. William’s long and rich experience spans the scientific, administrative, and quality aspects of regulated (ISO, GCP, GLP, GMP) pharmaceutical development and manufacturing areas and spans the translational interface (T1; late preclinical, early clinical) with a focus on oncology drug development and emerging disease vaccine development in BSL 2, 3 & 4 environments.

William is also well-versed in developing Quality Management Systems, documents and change control systems in GLP, GCP and GMP settings.

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Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.