Rui Almeida
Director Consultancy Services
Rui Almeida leads ValGenesis Product Lifecycle Management consultancy group, offering a range of services where science and engineering are coupled in areas such as process lifecycle management, quality risk management, and CMC strategy. Rui has a licentiate degree in biological engineering and a master’s degree in engineering management and nearly two decades of pharmaceutical industry experience, holding senior positions in technical services, quality assurance of IMP / commercial products, and project management in small and large pharmaceutical companies. Before joining ValGenesis, he served as PMO group leader in the services business segment of a CDMO.
DAY 1: OCTOBER 1st, 2024
SESSION: Implement a Risk and Data-Driven Approach to Achieve Right First Time Cleaning Validation
◆ Apply a lifecycle approach to cleaning validation, from process design (Phase I) to process qualification (Phase II) and continued process verification – CPV (Phase III).
◆ A methodology applied for each phase is presented with examples of what elements should be considered when building a CV strategy.
◆ Present a workflow for the creation of a risk-based cleaning CPV plan with key performance metrics to ensure process consistency and where process insights are used for continuous improvement throughout process life cycle.
◆ Benefits of going digital in end-to-end cleaning validation life-cycle management.
