Within a Quality System (QS), the ability to make sound decisions based on facts and good science is key to being compliant with the regulatory requirements as well as being economical to the business. Whether it is tracking customer complaints, identifying nonconforming material or products, managing audit findings, or implementing appropriate corrective and preventive actions (CAPA), having a well understood and integrated Risk Assessment process in place can improve product quality and regulatory or GxP compliance, and reduce legal liability.

This training workshop is designed to provide you with sufficient knowledge and skills to effectively participate in quality and compliance-related risk assessments.

It will provide you with a general understanding of quality management systems and processes, as well as an understanding of the Risk Assessment Process that provides the basis from which to conduct a structured risk evaluation.

The workshop will use examples and case studies drawn from the following real life scenarios to provide you with both worked examples and hands-on practice in the application of risk assessment tools for managing:

  • Customer complaints and recalls
  • Nonconforming materials and products
  • Negative internal and supplier audit findings
  • The CAPA process with Quality Risk Management (QRM)

Course content:

  • GxP and Quality System principles and key requirements for corrective action and continuous improvement
  • An overview of the Quality Risk Management QRM Process
  • The QRM Toolbox: what to use and when
  • Developing the Risk Registers
  • Building risk portfolios on processes and products
  • Putting the risk-based approach into practice

Who should attend:

If you are required to manage or perform retrospective risk assessments on manufacturing, quality and compliance problems then this course is for you.

It will also be beneficial if you are new to risk assessment, or as a ‘refresher’ if you are experienced QRM practitioner. It does, however, assume a good understanding of Quality Management Systems (QMS).

Format and Course Length: 

The 1-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.

Scheduled sessions run from 9am to 5pm unless otherwise specified.

Call us or click here to e-mail us and register your interest.

 

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