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 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.
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
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.