Topics that are new to PQLI will be introduced as the project expands to understand how the ICH Quality Vision can be implemented globally. Challenges that companies face introducing or adapting change management and knowledge management in a pharmaceutical quality system will be discussed from the viewpoint of both industry and regulators whether or not an 'enhanced,' quality by design approach is used. Regulators from FDA, EU and Japan will be invited to provide their findings reviewing applications and inspecting companies. Leading industry speakers will be asked to summarize their experiences. Opportunities will be given for participants to interact with regulators and industry colleagues.
At the conclusion of this session, participants will be able to: