Quality Risk Management Overview
Steven Laurenz– Chemical Engineering M.S.– Michigan State University
Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for an R&D Quality Assurance organization.
Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortium.
Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistics.
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. However, integrating 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 versus 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
- Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions
- Identify key QRM terminology
- Recognize the four (4) key components of Quality Risk Management
- Identify examples of QRM tools and their application
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.
Course Level- Beginning to advanced
Who Should Attend
This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. In addition, other related industries will benefit. Following personnel will benefit from the course:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Manufacturing engineers
- Production engineers
- Process owners
- Quality engineers
- Quality auditors
- Development professionals
- Senior development managers