The inaugural 2019 PDA Quality Week, Dec. 9-13 at the Capital Hilton in Washington, DC, presents not only one conference, but two conferences and a workshop.
At the Workshop, Building a Foundation and Culture for Quality Risk Management Integration,
attendees will be able to actively participate in defining successful quality risk management applications that they can then implement in their workplace. They will engage with regulators to understand how they assess a company's Risk Culture and how organizations should go about developing and sustaining a risk culture to prevent quality and drug shortage issues.
Questions such as, How does Quality Risk fit into the overall risk assessment and prioritizing of resources?, How important is it to build and maintain a risk culture in which risk can be identified within a company and its suppliers to be properly assessed and prioritized for proper mitigation?, and What are the Cultural Attributes that are needed to build a risk culture and prevent major issues leading to disasters? will be discussed.
As the Workshop is intended to be interactive and offer participants an opportunity to strategize on how they might help their organizations implement a total risk management program, three Workshop breakout sessions are included as part of the program.
Workshop 1 will engage participants in identifying ways for breaking the barriers to a successful risk culture and finding approaches to managing specific risk culture challenges. Topics such as the value proposition for implementing a QRM program and senior leaders’ influencing of risk culture will be on the table for discussion.
Workshop 1 will also address how academia has influenced the QRM culture. Professor Anne Greene from TU Dublin will speak about how the Pharmaceutical Regulatory Science Team (PRST) responded to the drive for a paradigm shift in quality from the international regulatory community and how the work of PRST researchers is based on proactive engagement with global industry and regulators in order to explore and address the challenges and opportunities of implementing science- and risk-based manufacturing approaches.
In Workshop 2, Lori Richter will lead a session on managing risk communication within an organization. The working session will explore how risk-based decision making can be demanding for leaders as they weigh both the benefits and challenges of taking risks in a regulated environment, where the patient is at the forefront of every decision and the importance of communication in ensuring critical risk information is conveyed to the right people at the right time. In this session, participants will break out into teams and work together to unravel a case study where decisions must be made, and communication must be clear.
Workshop 3’s theme is Risk Register Infographics. In this workshop, the attendees will have the opportunity to build posters to covers topics such as End-to-End QRM Program to manage product risks, the sources of risks to consider for a fictional product risk register, the infrastructure and governance to sustain a risk register, and more.
To conclude the day, attendees will present their posters at the cocktail hour, while enjoying finger food and drinks.
Although the Workshop is designed to be a standalone mini-conference, attendees are encouraged to participate in the full week program, depending on where they are at in implementing QRM in their companies.