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Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions In addition they will be able to identify key QRM terminology and recognize the four (4) key components of Quality Risk Management Finally they will have a strong understanding of the key concepts associated with the risk management risk tools and their application


  • Identify key QRM terminology
  • Identify examples of QRM tools and their application
  • Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions


Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system It can provide a proactive approach to identifying, scientifically evaluating and Controlling potential risks to quality Iintegrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization
There is much confusion on how to define risk and individuals often think of quality risk management as just a tool like FMEA analysis verses an overall QRM approach This training will explain the important concepts associated with a QRM approach


  • Recognize the purpose and value of Quality Risk Management (QRM), as well as how it applies to your job
  • Recognize the four (4) key components of Quality Risk Management


  • Process owners
  • Quality auditors
  • Quality engineers
  • Quality professionals
  • Production engineers
  • Production supervisors
  • Senior quality managers
  • Regulatory professionals
  • Manufacturing engineers
  • Compliance professionals
  • Development professionals
  • Senior development managers


Steven Laurenz, Principal Consultant – BioPhia Consulting Inc., has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled in taking new products from early laboratory stage to successful manufacturing launch. He is an expert in integrating Quality by Design and risk management into product development. He has proven experience in establishing a Quality System for a R&D Quality Assurance organization. Steven has headed product development departments at Abbott Laboratories and AbbVie Inc. and held leadership positions in numerous technical consortium. Steven Laurenz holds an M.S. in Chemical Engineering from the Michigan State University.

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