Part 1: Risk Management for Compliance

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.

  • 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
    • Auditing
    • Change Control
    • Product Complaints/ADEs
    • Deviation Investigation
    • CAPA
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.

  • 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)

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 course will be delivered as an online virtual-classroom training session.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training will be delivered as 2 full day sessions with breaks.

PDF Certificates will be provided to participants electronically.

Contact usto discuss your interest in a public or private delivery of this course on-site or in a virtual-classroom.

Refer to the Terms and Conditions