12 Sep 2023
5.30-6.30pm SGT | Online
Continued Process Verification concept was launched a decade ago when FDA launched the Guidance for Industry on Process Validation. Its effective implementation brings enormous advantages but also significant risks if non-integrated tools are used (e.g. data is collected from multiple sources, analyzed in a separate software and then compiled into a report format). Furthermore, the need to continually monitor the process is not compatible with practical and efficient practices in case a non-integrated set of tools is used. A real industry case of implementation of a digital fully integrated CPV program is presented, covering aspects related to 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 implementation 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
Led by:
Pedro Ferreira, Director, Validation and Quality Risk Management, Valgenesis
Pedro Ferreira has over ten years of experience in the pharmaceutical and chemical industries. Over the course of his career, he has held positions ranging from quality control and assurance of pharmaceutical products to the quality management of computerized systems and continuous improvement projects under the GMP scope. Pedro is currently leading ValGenesis Consulting’s Quality Risk Management division. In this role, he is responsible for delivering world-class validation, quality, risk, and knowledge management consultancy services spanning all phases of drug development and commercialization. Pedro holds a licentiate degree in pharmacy from the Polytechnic Institute of Lisbon and a master’s degree in biotechnology from the NOVA University of Lisbon.