GxP Quality Management System (QMS): Moving from Compliance to Quality

This ninety-minute webinar will examine how to successfully implement Quality. Subjects covered will include quality, systems and processes, the Savannah Principle, change management, Plan-Do-Check-Act cycle as well as benefits and barriers to a successful implementation and a general outline of the implementation process.

William D Fox
Instructor:
William D Fox
Date:
Tuesday, December 10, 2019
Time:
10:00 AM PST | 01:00 PM EST
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502775

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$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Overview:

There are those of us who think that the psychology of man, each and together, has more impact on markets, business, services, construction, and the entire fabric of an economy than all the more measurable statistical indices.- Malcom S. Forbes.

Too narrow a focus on regulatory compliance prevents organizations from embracing-and profiting from-quality and operational excellence. A major step towards ensuring GxP compliance and quality is the implementation of a quality management system (QMS). There are measureable benefits to having a sustained, operational QMS. However, implementing a QMS is, at its core, change and the derived benefits of any change are often forgotten when confronted with the uncertainty that accompanies it.

Change is hard. Seven out of ten workplace change initiatives fail (Leonard & Coltea 2015). Organizational change requires the installation of a new system when management's mandate is to keep the current system operating. Change requires processes previously performed at a subconscious level be moved to the conscious mind, initially slowing performance. Implementing a QMS is change at its most confounding, facilitating change while optimizing constancy.

Quality systems are a fundamental and soon-to-be required part of GxP compliance. A 2010 FDA report indicated that GxP compliance by itself does not guarantee quality and can even slow delivery to market, increase costs and negatively impact patient care.

The subsequent 'Case for Quality' initiative and related programs were designed to encourage GxP regulated organizations to commit to formal and systematic quality management systems rather than "check the box" compliance activities.

Understanding quality and quality systems and not simply GxP compliance is critical for implementing and sustaining a QMS. But what is quality? Who decides? How do you measure it? How do you manage it? What does it cost? The answers to must be part of the developing QMS and understood by managers and staff alike.

A quality system is a blueprint for planning, controlling, assuring and improving processes and products. If the quality policy and objectives are the foundation of the quality system then quality planning, control, assurance and improvement are the 4 pillars that support it.

Implementing a QMS must include developing quality standards distilled from customer feedback, regulations, industry standards and best practices. It must include procedures to control processes, ensure quality for customers and assure quality for management. A QMS implementation must also document the methodology used to guarantee that processes and products are optimized, improved and agile.

Being clear and conversant regarding quality, its cost, import and impact on an organization are paramount. Without it you cannot manage the process of implementing or sustaining a QMS nor can you obtain buy in from those that must navigate any changes, people.

Insufficient focus on people is a leading cause of failure for organizational change initiatives. People are the source of organizational value and fundamental to any attempt to improve. Sustained change is driven by people yet more often than not organizational change happens to people and not with them.

Many organizations believe you motivate people by making them fear failure and reach for monetary rewards to meet targets. This 'carrot and stick' attitude is ineffective with people. We are hard wired to resist change. Our brains evolved in a primitive savannah-like environment where change represented uncertainty and often resulted in death. Change was to be feared. As human beings we are far more comfortable with unhappiness than uncertainty. When change happens to us, most of us temper our reactions but at the same time limit commitment and engagement.

For a QMS implementation to be successful, it must occur in a psychologically safe environment where training, meetings and feedback are plentiful and non-threatening, ownership is desirable and people feel they can talk about difficult issues and trust what they say will be heard and explored rather than ignored, discounted, or criticized. Humans don't think creatively, work well with others, or make informed decisions when their threat responses are on high alert and they're gearing for a perceived fight.

The third factor critical for a successful QMS implementation, the plan, is also under-resourced or deprioritized. Plans are an imperative for any endeavor where a group of people must work towards a single goal. Human beings are remarkably adept at building mental scenarios. They also have an innate desire to socialize and share ideas and information. We are natural planners and yet inadequate planning is a significant negative contributor to QMS implementation failure.

Any successful implementation begins and ends with a good plan. A plan enables us to map alternate pathways, select the best path forward and prepare for and execute the journey. A plan should answer all the questions: what, who, why, where, how and how much. A plan is a guide for the translation of knowledge into action and a tonic for the uncertainty of change. Without a plan, goals are just wishes.

To be effective a plan must be simple, specific, realistic and complete. It should address the mission, vision and goals of the QMS. It should present an analysis of the strengths, weaknesses, opportunities and threats of the current situation and derived benefits of the new. It should document resources, schedules, strategies and operational tactics. Above all, a plan must be subject to change.

A plan must define the present, envision the future and describe a path through the intervening space. Not all change is beneficial. A plan will facilitate, guide and document directed, incremental change so that the change you want is the change you get.

Quality, people and a plan. Resources must be distributed equally between the three in order to change 'a chance' of a successful QMS implementation to a certainty. By cultivating uncertainty in the status quo natural human behaviors and reactions may be harnessed to affect change.

This 90 minute webinar reviews the roles these three key issues have in this transformative process. Subjects covered will include quality, systems and processes, the savannah principle, change management, Plan-Do-Check-Act cycle as well as benefits and barriers to a successful implementation and a general outline of the implementation process. Quality is constantly evolving. Consequently, we must continue to explore and develop new ways by which to define, measure and improve quality.

Why should you Attend: Managing GxP quality is critical and is a renewed point of focus by the FDA and pharma companies. Costly and competitive markets resulting from an increase in both regulations and numbers of existing drugs coming off patent and a decrease in new drugs to market inhibit pharma productivity and returns on investment.

Furthermore, recent studies have indicated that GxP compliance does not guarantee quality. The benefits of a clear and effective QMS are proven, documented and quantifiable. A QMS maximizes customer satisfaction, lowers costs and increases agility. It reinforces an organizations quality policy, quality objectives and core values at every level.

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 a minimum product quality but product and process excellence.

Implementing a QMS is a process that requires the competency, commitment and coordination of management, production staff and support staff. Understanding quality, developing people and developing and communicating a plan will increase the likelihood of an effective QMS development and deployment, compliance with quality drivers and increased customer satisfaction.

Areas Covered in the Session:

  • Quality
    • Case for Quality
    • Quality
    • Cost of Quality
    • Quality Management System (QMS)
    • Elements of a QMS
    • Quality Assessment
    • Process Mapping, Control and Optimization
    • Systems and processes
    • Compliance versus Quality
    • QMS Implementation Benefits and Barriers
  • People
    • Change Management
    • Evolutionary Psychology
    • The Savannah Principle
    • Changing Behavior
    • Culture
    • Ownership
  • Plan
    • Management Commitment
    • Elements of a Plan
    • Plan, Do, Check, Act Cycle

Who Will Benefit:
  • Senior Managers, Managers & Supervisors
  • Process Owners
  • Departmental Heads
  • QA,QC and Continuous Improvement Managers & Staff
  • Quality Consultants
  • Regulatory and Compliance Managers


Speaker Profile
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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