Level: Advanced Workshop Based
ISPE CEUs: 2.0
Type: Classroom Training Course
Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulators expect that QRM is inherently built into the backbone of the Quality Management System (QMS) by using a lifecycle approach to implement both formal and informal risk tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks.
The application and the complexity of risk management tools need to be appropriate to the scope of the risk event, the level of risk, the desired output from the risk assessment, and the elements of the QMS under evaluation. In addition, the company’s overall approach to Risk Management should be defined in a formal Risk Management Plan (RMP). The facilitator of the Risk Assessment event is key to the successful outcome of the event through their involvement in preparation, tool selection, communication of outcomes, and compliance with the defined Risk Management program.
This highly interactive, advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments. This three-day program will allow attendees to evaluate their company’s QRM program against current industry and regulatory expectation (Day 1), develop enhanced risk assessment facilitation skills (Day 2), and implement what they have learned through the hands-on leadership of case studies (Day 3).
Day 1 will dive into specific strategies and discussions on the essential elements of a QRM program as defined in ICH Q9 and will utilize numerous breakout sessions to allow participants to consider improvements for their company’s QRM program and network with other participants to share best practices. Specific topics covered include:
Day 2 provides insight into strategies for effective risk assessment facilitation including warning signs in team dynamics that facilitators should monitor and eliminate. These discussions will include breakout sessions for deeper discussion and prepared case studies for facilitation preparation and practice. Specific topics covered include:
Day 3 provides time for participants to share their specific risk assessment challenges and facilitate successful risk assessment outcomes. Participants should come prepared to work in groups to discuss their own real-life challenges and devise workable and creative solutions to realistic problems and case study scenarios, facilitated by expert trainers. By working through selected participant case studies, participants will gain experience in facilitating and executing formal risk evaluation tools like FMEA and informal risk tools to facilitate brainstorming like Fishbone, 5-whys and FTA. Specific topics covered include:
While some case studies will be provided, participants are invited to bring examples (made generic or non-specific if necessary) where they have found application of risk tools challenging for the group discussion and engagement. Case studies may come from any area of the business where QRM is applied such as:
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
Review the early stages of QRM implementation within the Pharmaceutical Industry, company applications of QRM questions asked by Regulators and how QRM can focus on building quality into the product, process, and/or system in the early lifecycle stages.
NOTE: It is strongly recommended that participants be familiar with basic concepts of ICH Q8(R2), ICH Q9 and ICH Q10 and have a fundamental understanding of key quality systems prior to attending this course.