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?

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This training course can help you by providing you with sufficient 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

You will learn about:

  • Manufacturing considerations: what can go wrong, complex processes and systems
  • GMP requirements
  • An overview of the Quality Risk Management Process
  • The Quality Risk Management Toolbox: what to use and when
  • Conducting Process Risk Assessments

Case studies drawn from the following real life scenarios will be workshopped to provide you with both industry examples and hands-on practice in the use of three of the more complex process risk assessment tools (defined in ICH Q9) – PHA, FMEA, HACCP:

  • Bioburden risks in the manufacture of non-sterile liquids and creams
  • Sterility risks in the aseptic filling of injectables
  • Foreign particle contamination in injectables
  • Foreign particle contamination in the manufacture of APIs
  • Cross contamination in multiple product plants
  • Low / high potency in solid dose manufacturing
  • Misbranding of tablets / capsules

Participants

This course is designed for both personnel new to process 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.

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.

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

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