Next Generation Project Validation Processes for Pharmaceutical Development

Presented by

Gábor Papik - Gedeon Richter | Kalman Keresztesi - Controsys

About this talk

Gedeon Richter is a multinational pharmaceutical and biotechnology product developer. The company faced systems validation challenges of its new computerized manufacturing sites and projects. In cooperation with global pharma automation expert & system integrator ABB they realized a project to complete validation processes with reduced effort and within a shorter timeframe, ensuring full GAMP® 5 compliance. In this webinar, experts from Gedeon Richter and Controsys will discuss the lessons learned in applying codeBeamer ALM to achieve efficient, fast, and fully paperless systems validation. The discussion will cover questions of documentation, traceability, and maintaining historical data in a digital system. During the conversation, we’ll touch on the following topics as well as receiving audience questions: -What are the main challenges in the validation of pharmaceutical systems and what is the primary need driving the development of these systems? -At what stages of the project do major validation challenges arise? -How can pharmaceutical companies collaborate efficiently with system integrators in validation processes? -How does a pharmaceutical company benefit in the short to medium term by applying a software-based validation solution? -How have responsibilities and communication processes changed since the transition from paper-based systems?

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