Advanced processes in pharma

FEATURED TOPICS:

  • THE VISION IN PHARMA DIGITALIZATION: APPROACHES AND CHALLENGES

Digital transformation is affecting the whole product lifecycle, from R&D to product supply and patient care, bringing patients and their quality of life to the centre of the pharma business. This session will introduce the landscape of the digitalization inside the manufacturing processes of pharma companies and will discuss hands on experiences of that. By applying digital emerging technologies, pharma companies can put in place more robust and flexible manufacturing processes, speeding up the delivery of medicines to the market while ensuring a consistent performance on products. The pharma digitalization enables real time data management, data integrity compliance and possibility of real-time decision-making, improving the overall quality of the manufacturing process.
Case studies and keynote presentations followed by a final panel discussion with the involvement of participants.

  • THE CULTURE CHANGE TOWARDS THE DIGITALIZATION

The ICH Q8, Q9, Q10, Q11, Q12, outline an integrated systems approach for the implementation of quality, and represent the cultural foundation on which to build the architecture of a system that wants to embrace digitalization transformation. Quality by Design (QbD) and Process Analytical Technology (PAT) are the fundamental tools for implementing Continuous Manufacturing. The industry recognizes that QbD and PAT lead to robust, predictable processes that allow for a high product quality and better management of business goals (FDA, 2016). The application of these concepts to processes requires a high degree of effort and commitment by the senior management, but at the same time represents a key step to pave the way to the following digitalization, for which a deep process understanding is mandatory.
Case studies and keynote presentations followed by a final panel discussion with the involvement of participants.

  • THE ROADMAP TO DIGITALIZATION

Company managers are required to fully understand which are the main steps to be taken before driving the company to the digitalization phase. A cultural change and a subsequent design of the main processes need to be accurately projected and prepared, to ensure high chances to succeed in digitalization.
Experts will share their experience during keynote presentations and a final round table with the involvement of participants.

WHY ATTEND?

This conference provides a great opportunity to learn and to understand the current challenges in the digital transformation: which stage are the pharma companies now? Which is the direction? How to get to the goal in the most effective way? Learn it from international renowned experts and colleagues who are engaged in this process.

Advanced processes in pharma 4.0

WHO SHOULD ATTEND?

The conference is aimed specifically at Pharma, Biotech and Medical Device Companies, Regulatory bodies and Technology Suppliers interested or involved in the Digital transformation of their processes.

Advanced processes in pharma 4.0

Via Dei Pratoni, 16 - 50018 Scandicci (FI)
Tel. (+39) 055 0465181
E-mail: info@pharmaeducationcenter.it