Presented by: Pedro Ferreira, Head of Validation and Quality and Risk Management Services, ValGenesis®

The concept of Continued Process Verification (CPV) was born a decade ago when the FDA launched the guidance for process validation. CPV introduces enormous advantages when implemented effectively, but carries significant risk if non-integrated collection, analysis, and reporting tools are used. In fact, a non-integrated set of tools is not compatible in the practice of continually monitoring the process. Here, we’ll present a real industry case study of implementing a fully integrated, digitized CPV program, covering crucial aspects such as data mapping, systems integration, use of a risk-based approach to define and refine CPV plan, and project business value generation.

Topics covered in this session:
• Overview of current regulatory framework on CPV
• Imperatives for the implementation of a CPV program
• Benefits of implementing a CPV program
• Challenges of a “classical” CPV program versus digital approach
• Step-by-step approach for digital CPV plan implementation

Takeaways:
• Requirements for a digital CPV system
• Industrial case study example
• Practical ROI example