New expectations are bringing about significant changes in Process Validation approaches. As a result, companies are struggling to understand how these expectations can be transformed into practical actions and business processes.
ISPE is offering this interactive, topic-specific Conference on how to implement these changes into your business, gain clarity and be compliant with the FDA Process Validation Guidance.
Subject Matter experts will offer insight around the Guide and suggest practical approaches to satisfying these requirements. A question and answer session will follow, offering an opportunity for you to gain clarity around the Guide.
Through small group exercises and discussion forums, you will be able to practice application of the lifecycle approach and discuss approaches from your colleagues. These exercises will focus on acceptance criteria, sampling plans, determining batches and the elements of a heightened monitoring plan. Larger group sessions will provide additional opportunity for benchmarking approaches.