Press Room

Guy Villax speaker at 2017 PDA/FDA Conference

Start
Monday, September 11, 2017 - 10:45
End
Monday, September 11, 2017 - 11:45
Location: Washington DC, United States

Presentation Title: Investing in Quality to Meet Business Objectives
10:45 a.m. – 11:15 a.m.

guy villax portrait photo Hovione

Guy Villax

Non-Executive Board Member

Degree in Accounting and Financial Management

Guy Villax has a degree in Management from the University College at Buckingham, UK.

Guy Villax was Hovione's Chief Executive from 1997 to 2022, having previously worked at Price Waterhouse in London and Hovione in Asia.

Guy holds leadership positions at industry associations and in Portuguese state organizations: Rx-360, Health Cluster Portugal, Portugal’s Business Roundtable; and the ANI (Portugal’s National Innovation Agency) and the CNCTI (National Council for Science, Technology and Innovation).

 

 

 

 

Session: Current Quality Challenges for Pharmaceutical Executives
As the biopharmaceutical industry continues to evolve, major challenges associated with globalization and complexity of the supply chain emerge. In addition, companies now face internal pressures related to the cost of medicines, dealing with various global regulatory frameworks and changing expectations in evolving healthcare systems. The challenges have led an industry drive to adopt new business and quality technologies and to pursue partnerships with global regulators to help companies understand and facilitate implementation of changing regulations. This session will focus on major challenges that quality professionals should be aware as they interact with executives at their firms, how ensuring quality can play a part in overcoming those challenges and the crucial role of the executive in driving quality within the company.
 

The 2017 PDA/FDA Joint Regulatory Conference is the premier pharmaceutical manufacturing event where you can engage directly with U.S. FDA representatives and industry experts! Over two and a half information-packed days, FDA regulators will provide updates on current efforts affecting the development of global regulatory strategies, and industry experts will present case studies illustrating how they use global strategies to improve the quality of medical products. Hear what the Conference Co-chairs and past attendees have to say about this exciting event!

 

Live from PDA/FDA: Culture of Quality 

Empowering employees with a strong sense of ownership can lead to improved outcomes and increased cost efficiency.

 

 

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

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