Quality QMS


Quality Management Workshops

Quality Management Workshops - Best Practice Skills Training for Quality Professionals

Keeping up-to-date with today's rapidly changing regulatory environment requires extraordinary effort. Fortunately, MasterControl's Quality and Compliance Consulting Team offers on-demand quality management best practice training that provides quality professionals with the skills needed to stay one step ahead of complex quality and regulatory trends and developments. Our instructors, who have trained investigators from the FDA, EMEA, and regulated organizations worldwide, present two-day on-demand workshops on five core quality processes: CAPA, audit management, risk management, supplier management, and document management. Workshops are delivered on-site at the customer's facility and can be customized to align with the specific regulatory requirements of the customer's industry sector. On-site quality consulting services are also available. To learn more, please download one of the free documents listed below.

6 Must-Haves for a Quality Management System (QMS)

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Quality Management Workshops - Education and Training in Five Core Competency Areas

Maintaining a compliant quality system requires having a well-trained team. MasterControl's quality management workshops were developed in accordance with industry best practices, and backed by our extensive experience implementing hundreds of quality management software solutions. To ensure adequate personalized attention, workshops are limited to 14 participants. Our current workshop offerings include:

  • Corrective and Preventive Action (CAPA) Management Workshop
  • An efficient CAPA system can increase an organization's compliance and profitability significantly. This workshop teaches participants the skills needed to become a superb CAPA investigator including how to:

    • Avoid "death by CAPA"
    • Identify and prioritize events based on risk
    • Implement processes that pass global regulatory standards (FDA, EMEA, etc.)
    • Develop a solid method for investigating problems
    • Verifying and validate corrective actions that work
  • Audit Management Workshop
  • Few organizations have the luxury of hiring well-seasoned professional auditors. This workshop teaches participants how to spearhead audit functions at their organizations including how to:

    • Understand audit standards and techniques
    • Interpret and read a variety of reports
    • Think objectively and judge with adherence to standards
    • Take outstanding notes and write well-documented findings
    • Remain calm and composed under pressure
  • Risk Management Workshop
  • It's imperative for an organization to integrate its quality system with a risk-based approach that manages hazards and harm in an auditable, effective manner. This workshop teaches participants how to:

    • Understand the basic concepts of risk management
    • Understand the process model approach
    • Employ the risk management process
    • Know the intent and application within ISO 14971
    • Understand the practical role of quality risk management and its use within a QMS
    • Implement risk actions smoothly and effectively
    • Be more proactive in their risk-based approach to quality
  • Supplier Management Workshop
  • An integrated supplier quality management approach can benefit any business operating in a regulated environment. This workshop teaches participants how to:

    • Understand the context of supplier control
    • Understand the risk-based approach
    • Employ best practice preventive controls through supplier evaluation
    • Know the intent and application of regulatory guidance and expectations
    • Understand the practical role of event management for suppliers
    • Implement monitoring and improvement actions effectively
    • Become proactive in the supply chain by utilizing resources effectively
  • Document Management Workshop
  • The most important aspect of any QMS is the way in which it is documented to manifest the system hierarchy. This workshop teaches participants how to:

    • Understand the basic concepts of quality planning
    • Understand process model concepts
    • Apply risk-based consideration for document system design
    • Know the intent and application within ISO standards and related compliance
    • Understand process flows and the merit of using them within a QMS
    • Implement risk actions, maintain structure, and eliminate ambiguity within process activities (e.g., disposition points)
    • Become more proactive in the design, application, and improvement of a documented system

Closed loop quality management system process flow using MasterControl's Enterprise Quality Management Software System (EQMS)

Quality Management Coaching and Consulting Services

To ensure success from the classroom to the field, on-site quality management workshops can be supplemented with coaching and consulting services, which also focus on five core processes: document management, CAPA management, audit management, supplier management, and risk management. Quality coaches are available to work on-site with an organization's quality team and to guide the team through all phases of the quality management process. A host of business assessment tools, including gap analysis, are also available.

For More Information on MasterControl Quality Management Workshops

For more information about our quality management workshops, contact the MasterControl Quality and Compliance Consulting Team or call 866.747.8767 today.

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