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
• Requirements for a digital CPV system
• Industrial case study example
• Practical ROI example
Head of Validation and Quality and Risk Management Services, ValGenesis®
Pedro is currently leading the Validation and Quality and Risk Management Consultancy Services at ValGenesis, delivering Validation, Quality, Risk and Knowledge management consultancy services to life-science industry from early drug development phase to commercial coupled with a portfolio of digital solutions to help companies to meet Industry 4.0 standards. His professional background has been in the pharmaceutical and chemical industries for over 10 years, with roles ranging from Quality Control and Quality Assurance of pharmaceutical products to the quality management of computerized systems and continuous improvement projects under the GMP scope. Pedro has a degree in Pharmacy and a master’s in Biotechnology.