The regulatory environment is changing - shifting to a more risk-based approach to quality management. Without a comprehensive, proactive quality risk management (QRM) program in place, an organization is exposing itself to a host of liabilities and possible enforcement action. The on-site risk management workshop will teach quality professionals how to properly identify, analyze, evaluate, and control risk throughout their organizations, as well as how to document and demonstrate an effective risk management program during inspections or audits. Upon completion of the course participants will possess the confidence and knowledge needed to develop and implement an effective global risk management strategy - and the ability to translate their company's compliance commitments into an effective risk-based approach.
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Quality risk management is more than having a good "feel" for assuring outcomes to processes; it is a multifaceted process that manages how issues are handled in order to avoid, reduce, or even eliminate hazards and harm in any complex operating environment. This comprehensive risk management workshop, which is delivered on-site at the time and location of your choice, will teach you the risk-based approach necessary to effectively evaluate risk and successfully identify the events that create potentially unsafe or harmful conditions. Topics to be covered include:
Are you prepared for your next FDA inspection or audit? How well do you know the intent and application within ISO 14971? The quality risk management workshop will provide you with the skills and tools you need to eliminate the following common QRM issues:
The 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 risk management workshop agenda.
The quality risk management workshop is appropriate for individuals who are regularly tasked with assessing and mitigating risk in a quality system. Examples include research and design engineers; quality assurance, manufacturing, and regulatory compliance professionals; customer service representatives, and other team members working in life science and/or regulatory environments.
The risk management workshop is one of five on-site 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, CAPA, document management, and supplier management. All workshops are delivered on-site at the time and location that's most convenient for your organization, and can be customized to align with the regulatory requirements of your industry sector Click on the links below for more information on the additional workshops:
For more information about the risk workshop, or any of our quality management workshops, contact the MasterControl Quality and Compliance Consulting Team or call 866.747.8767 today.