Implementing a GxP Quality Management System

This 90 minute webinar provides an introduction to the planning and implementation of a GxP QMS, Key factors influencing a successful QMS implementation such as communication, commitment, expectations, engagement, benefits, barriers, findings, failures and training will also be discussed.

William D Fox
Instructor:
William D Fox
Date:
Friday, July 26, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502655

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

Quality management systems are an integral part of a successful organization. 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 biotech pharmaceutical and medical device companies whose products are delivered directly to the human body. Managing quality in the biotech sector is critical and represents a point of focus by the FDA and biotech companies.

Markets are increasingly costly and competitive due to increasing regulations, fewer drugs coming off patent and fewer new drugs making it to market. Additionally, lower pharma productivity and smaller returns on investment all 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 successful 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 process improvement mechanism which facilitates alignment with FDA regulations and provides 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. Predicative and proactive measures including implementing a quality system with a continuous quality improvement methodology are being embraced in order 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, coordination and confidence 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. We are, however, hard wired 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 and motivating them accordingly.

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

Why should you Attend: Quality and quality management systems (QMS) are becoming a necessity for organizations as a result 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 GxP 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 effective GxP QMS development and deployment, compliance with quality drivers and increased customer satisfaction.

Areas Covered in the Session:

  • 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:
  • 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


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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