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Part 1: Risk Management for Quality System

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 is designed to provide you with relevant 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.

Content

  • The critical importance of quality assurance or Quality Management Systems (QMS)
  • The goal of risk management in managing compliance
  • The key systems – how they integrate and where risk assessment can be applied to appropriate sub-systems.
  • The use of risk assessment in
    • Document Control
    • Change Control
    • Training
    • Customer Complaints
    • Deviation Management
    • Internal Audits
    • CAPA
  • The central role of CAPA system in QMS

Part 2: Risk Management for Process

Quality Risk Management (QRM) was introduced to the GMPs in 2009 and should now be an integrated part of your daily pharmaceutical manufacturing operations…but is it? Do you know which QRM tool to use in different situations? Are you satisfied that the time and effort in conducting risk assessments is adding real value to your business? Are you confident that your risk evaluation has identified the appropriate level of manufacturing controls? This training can help you by providing you with relevant knowledge and skills to effectively participate in process risk assessments.  You will gain a general understanding of manufacturing processes and how they are controlled, as well as an understanding of the Risk Assessment Process to ensure you have a basis from which to conduct a structured risk evaluation.

Content

  • Manufacturing considerations: what can go wrong, complex processes and systems
  • GMP requirements for risk assessments
  • An overview of the Quality Risk Management Process
  • The Quality Risk Management Toolbox: what to use and when
  • Conducting Process Risk Assessments:
    • Preliminary Hazard Analysis (PHA)
    • Hazard Analysis and Critical Control Points (HACCP)
    • Failure Mode and Effects Analysis (FMEA)

Participants

This course is designed for both personnel new to risk assessment as well as more experienced QRM practitioners.  You will benefit from this course if you have a simple interest in or have any level of responsibility for risk assessments of manufacturing processes. It does, however, assume a good understanding of Quality Management Systems (QMS).

Format and Course Length

The 2-day course involves a lively mix of case studies / workshops and tutorial sessions. The delivery method is collaborative involving a small group and facilitator, which has been shown to enhance effective learning and critical thinking skills of participants. You will receive PDF copies of the training material and a Certificate of Attendance.

Possible Date

Singapore, July 2020.

Dates can be flexible and we encourage you to contact us with your needs so we can discuss how to help.

Refer to the Terms and Conditions