Implementing a GxP Quality Management System

Why Should You Attend:

Implementing a quality management system (QMS) can and should affect every aspect of an organization. An unsuccessful QMS implementation can, at best, be a waste of resources and, at worst, lead an organization farther from its quality goals. While each system is unique they contain homologous concepts and practices. Competitive markets, informed customers and rapidly changing business environments make QMS a necessity for organizations. This is especially relevant for pharmaceutical companies whose products are delivered directly to the human body. Managing quality in the pharmaceutical industry is critical and represents a point of focus by the FDA and pharma companies. Costly and competitive markets resulting from an increase in regulations and numbers of existing drugs coming off patent and a decrease in new drugs to market, pharma productivity and returns on investment necessitate not only product quality but process quality as well.

The benefits of a clear and effective QMS are proven, documented and quantifiable. At its roots a QMS maximizes customer satisfaction, lowers costs and increases agility. It reinforces an organizations quality policy, objectives and core values at every level and integrates an iterative improvement mechanism. A successful QMS not only provides alignment with FDA regulations but provides a mechanism for the optimization of an organization’s product and support processes. It raises the bar, ensuring not only minimum product quality but product and process excellence.

In 2011 the Food and Drug Administration (FDA) launched its ‘Case for Quality’ initiative to encourage drug and medical device developers and manufactures to go beyond simply complying with regulatory requirements and focus on organizational improvement including patient care and outcomes. This represents a shift in compliance. Regulations are now seen not only as a simple checklist but as a starting point for excellence that permeates the entire organization. Predicative and proactive measures including implementing a quality system with a continuous quality improvement methodology are being embraced to increase quality, decrease costs and align the focus on the customer.

Quality management systems vary across and within industries and organizations. Quality drivers such as industry standards, regulations and best practices add to the unique nature of each organization’s QMS resulting in a tailored design and implementation strategy with an organization’s specific goals, processes and customers in mind. Implementing a QMS affects every aspect of an organization’s performance. An unsuccessful QMS implementation can, at best, be a waste of resources and, at worst, lead an organization further from its quality goals.

The implementation of a QMS is, in fact, a process that requires the competency, commitment and coordination of all production and support staff and management. Understanding some fundamental QMS design and implementation concepts, benefits and barriers will increase the likelihood of an effective deployment.

A QMS is inherently a vehicle of change yet evolution has hard wired us to resist change and the uncertainty and fear of loss associated with it. Change may cause some to fear for their jobs or threaten those with perceived authority or those who have a stake or ownership in the status quo. In these stressful situations a person’s body responds with real physical consequences. Part of a successful implementation and administration is managing this fear and uncertainty, creating a psychological safe space for employees.

This 90 minute webinar provides an introduction to the planning and implementation of a QMS using a pharmaceutical QMS as a working model. Topics include quality concepts, managing quality, systems and processes, managing change, the plan-do-check-act cycle, positive psychology, the growth mindset, gap analysis and the internal audit. Key factors influencing a successful QMS implementation such as communication, commitment, expectations, engagement, benefits, barriers, findings, failures and training will also be discussed.

Quality and quality management systems (QMS) are becoming a necessity for organizations because of competitive markets, informed customers and rapidly changing business environments. For pharmaceutical companies, whose products are delivered directly to the human body, QMS are often a requirement. The implementation of a QMS is a process that 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 an effective QMS development and deployment, compliance with quality drivers and increased customer satisfaction.

Areas Covered in the Webinar:

• Quality Management System (QMS)
• Change Management
• Quality Documents
• Plan, Do, Check, Act Cycle
• QMS GAP Analysis
• Process Mapping, Control and Optimization
• QMS Audit
• QMS Implementation Benefits and Barriers

Who Will Benefit:

The following professionals from Pharmaceutical and Biotechnology Industries

• Senior Managers, Managers & Supervisors
• Process Owners
• Departmental Heads
• QA, QC and Continuous Improvement Managers & Staff
• Quality Consultants
• Regulatory and Compliance Managers
• Change Control/Documentation Staff

William D Fox
Quality Management Professional, Texas Biomedical Research Institute

William D Fox is a quality management professional with a background in clinical research and quality assurance. William’s experience includes scientific, administrative, and quality aspects of regulated (ISO, GCP, GLP, GMP) pharmaceutical development and manufacturing 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 also has experience developing quality management systems, documents and change control systems in GLP, GCP and GMP settings.

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