This 3-hour workshop consists of 3 plenary presentations and two breakout sessions. ICH Q9 (R1) Topic Leader, Kevin O'Donnell from EMA will summarize the rationale for and changes to the recently issued ICH Q9, Quality Risk Management revision. There will be two industry presentations summarizing ISPE activity to support the ICH Q9 Implementation Working Group with provision of case studies covering the topics of formality, subjectivity, decision-making and product availability. These will be followed by two breakout discussion sessions, each session covering two of the above topics in parallel. A participant could, therefore, attend and contribute to two out of the four breakout topic discussions. The Workshop will conclude with feedback from the breakout groups, a Q&A and closing remarks.