Regardless of sector, size, structure, or maturity, regulated organizations must establish an appropriate quality management system (QMS) to be successful. The most important aspect of any QMS is the way in which it is documented to manifest the system hierarchy. The two-day document workshop, delivered on-site at the customer's facility of choice, explores the process model approach for the creation and operation of an effectively documented QMS - one that complies with FDA, ISO, and other regulatory standards. The levels of complexity, integration, and application are examined to bring about a streamlined system that is effective, efficient, and not burdened by superfluous documentation.
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Poor or incomplete documentation accounts for more noncompliances during audits than virtually anything else. However, it is often difficult to know just how much documentation is enough. Although FDA regulations and international standards require regulated organizations to establish compliant documentation processes, few, if any, concrete guidelines are given on how to create and implement a compliant documentation system. In just two days, the document workshop will teach participants the good documentation practices they need to dramatically improve their organization's efficiency and effectiveness. Topics to be covered include:
The document workshop provides quality professionals with the skills and tools they need to eliminate the following common documentation problems:
The document workshop is taught using a blended approach of classroom and real-life application. This "how-to" approach significantly increases knowledge retention and allows participants to apply the skills as they learn in a dynamic setting. Click here to review the workshop agenda.
The document workshop is appropriate for individuals who are regularly involved in preparing plans, procedures, and instructions as part of a documented management system, especially those responsible for document maintenance and improvement.
The on-site document workshop is one of five quality management workshops offered by MasterControl to help quality professional gain the skills they need to stay current and compliant in the workplace. Additional workshops are offered in audit, risk, CAPA, and supplier management. All workshops are delivered on-site at the customer's facility and can be customized to address specific industry compliance requirements. Class size is limited to 14 participants. Click on the links below for details on the additional workshops:
For more information about the document workshop, or any of our quality management workshops, contact the MasterControl Quality and Compliance Consulting Team or call 866.747.8767 today.