Risk Workshops

Learn to Document and Demonstrate an Effective Risk Management Program with the Help of MasterControl's Quality Risk Management Workshop

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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MasterControl's Quality Risk Management Workshop Course Overview

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:

  • Quality Event Evaluation for Risk - Participants will examine the feeder events to their QRM system, as well as learn to manage complaints, deviations, audit findings, and other quality events; these feeder events will also be clarified using key questioning patterns regarding QRM.
  • Issue Review Risk Analysis - Participants of the quality risk management workshop will learn to identify and prioritize events based on risk and set up risk gateways into electronic solutions.
  • Risk Evaluation (Solutions) - Participants will apply critical thinking skills, such as decision making, to implement preventive controls that best address risk.
  • Implementation and Effectiveness Checking - Participants will learn how to verify, validate, implement, monitor, and confirm the success of their organization's QRM strategy.
  • Post Production Improvement - Participants will develop a compliant, effective means to apply lessons learned from the in-service experience to improve or change their process or product.
  • Writing RMP Reports - Participants of the quality risk management workshop will learn the steps to writing and documenting a risk management plan clearly and concisely.

The MasterControl Quality Risk Management Workshop Will Help You Avoid These Common Risk Management Issues

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:

  • Ineffectively showing traceability of the risk-based approach
  • Poor selection of prioritized risks
  • Insufficient presentation of data analysis
  • An inadequate QRM approach that would not pass global FDA and EMEA standards
  • No uniform, thorough method for analyzing risk
  • No process for verifying and validating preventive actions for control and outcomes

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.

Who Should Attend the MasterControl Quality Risk Management Workshop?

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:

  • Supplier Workshop
  • Audit Workshop
  • CAPA Workshop
  • Document Workshop

For More Information on MasterControl's Risk 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.