After attending this course you will be able to:
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. This training will explain the important concepts associated with a QRM approach.
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 understand 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 tools and their application.
This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms. 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. Following personnel will benefit from the course:
Years of Experience: 15+ years
Areas of Expertise: Quality by Design, Risk Management, and Quality Assurance
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 UniversityView all trainings by this speaker