Day One

• Establishing a phase-appropriate raw material strategy that supports both early development flexibility and late-stage regulatory expectations
• Navigating evolving regulatory expectations for raw materials
• Evaluating supplier strategies, including sole vs dual sourcing, to mitigate supply chain risk while maintaining product comparability and regulatory compliance

• Setting up a simple and structured raw material risk approach suitable for small and growing organizations
• Prioritizing testing and qualification effort when time, data, and resources are limited
• Assessing risk early to avoid downstream delays and rework

• Qualifying multiple materials to enable parallel testing during early development
• Aligning early-stage work with the requirements for transfer into stage two
• Balancing speed with quality to support a reliable and effective transition

• Exploring how companies prioritize raw materials using risk-based frameworks
• Comparing approaches to material qualification, sampling strategies, and CoA expectations
• Discussing regulatory experiences shaping raw material decisions across development stages

Private lunch hosted by Instant Systems, please inquire at info@hansonwade.com for more information

• Defining acceptance criteria based on process characterization rather than supplier specifications
• Understanding when variability can be absorbed and when it becomes a process risk
• Disqualifying lots with confidence using data instead of assumptions

This interactive session will create space for peer-to-peer exchange on how teams are managing raw material variability, qualification, and process risk in practice. Through structured discussions, attendees will share approaches, compare challenges, and explore how to make more confident, data led decisions across development stages.

• Exploring approaches to defining and managing acceptable material variability
• Comparing strategies for material qualification and release decisions
• Sharing practical insights on using data to improve confidence and reduce process risk

• Turning raw material failures into a catalyst – redefining supplier strategy through a centralized, data-driven MRC model
• Applying integrated risk scoring (beyond PRAM) to pinpoint and prioritize highest-risk suppliers
• Deployment of targeted technical due diligence visits to shift from reactive firefighting to proactive risk mitigation

This interactive working session brings together the key discussion points surfaced across the day’s presentations to explore where approaches align and where they differ. In small groups, you’ll examine shared challenges across raw material selection, qualification, and control, drawing on real-world experience from across functions including QC, MSAT, and supply chain. The session will close with group feedback to capture collective insights, helping you refine your approach and carry forward key learnings into day two.