Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture
NIBRT is delighted to partner with the Quality Risk Management Institute to launch the “Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture” on the award winning NIBRT Online Academy.
Throughout the course of 6 modules you will have the opportunity to discover the core principles and key approaches necessary for the effective Quality Risk Management (QRM) across the biopharmaceutical product life cycle. The critical behaviours which can best protect patients are a key focus of the course as well as the critical role of leadership in establishing a proactive culture of risk prevention.
Preventing and reducing risk is everyone’s job in a regulated GMP environment and risk management cannot be the domain of a small number of QRM subject matter experts. This fundamentals course offers the opportunity to level set the practice of risk management right across your organisation and recalibrate the prevalent risk culture to focus on prevent and reduce rather than detect and correct.
Module 1: Patient Focused Risk Management
Module 2: Fundamentals of Risk Management
Module 3: Regulatory Requirements for Quality Risk Management in the Biopharmaceutical Industry
Module 4: Implementing Effective Risk Control Strategies
Module 5: Application of Quality Risk Management Every Day
Module 6: Your Role in Preventing and Reducing Product and Patient Risk
Assessment: This unique scenario-based assessment provides competency-based assessment and certification to test your comprehension of how to apply effective behaviour-based Quality Risk Management within the biopharmaceutical industry.
All personnel involved in the GxP function in Manufacturing Operations, Quality Assurance, Quality Control, Engineering, Logistics & Distribution, Technical Operations, Validation, Warehousing & Dispensing, Global support functions including Process technicians, QC Laboratory analysts, Production supervisors, Packaging line operations personnel, Manufacturing Ops Executives and Managers, Engineers and Technical Ops Executives, Maintenance and calibration technicians, QA executives and Managers and Warehouse personnel.
The Quality Risk Management Institute (QRMi)
The mission of the QRMi is to enhance patient safety in the pharma industry through the promotion of effective Quality Risk Management (QRM) and the professionalization of QRM across all roles. QRMi’s Knowing, Doing, Being learning framework gives you the opportunity to acquire knowledge, practice skills, become competent in the use of tools and techniques and focus on your values and behaviours that can support risk prevention and reduction in your role.
About the Author, Dr. Nuala Calnan
Dr. Nuala Calnan has over 20 years’ experience in the biopharmaceutical industry across operations, new product introduction and facility start-up and manufacturing. The focus of Nuala’s research, as well as her work with industry and leading regulatory agencies includes; advancing the maturity of QRM as practiced in the industry and demonstrating the role that Knowledge Excellence, Operational Excellence, & Cultural Excellence play in delivering enhanced quality outcomes for the patient.
Nuala is an Adjunct Research Fellow with the Pharmaceutical Regulatory Science Team at Technological University Dublin, Ireland, where she teaches and leads a number of patient-focused regulatory science research projects at Masters and PhD level.