Agenda
In 2004, the Food and Drug Administration (FDA) issued a guidance with the goal of highlighting opportunities and developing regulatory processes that encourage innovation. This Process Analytical Technology (PAT) guidance encouraged companies to thoroughly understand their processes, as a high degree of process understanding reduces the risk of manufacturing a product of poor quality.
In PAT, a process is designed and its most critical parameters are monitored as it occurs. A control system, then uses these results with the goal of obtaining a product that will always have the expected quality. PAT reduces the number of samples sent to a remote quality control laboratory, since the product is evaluated as the process occurs. Thus, PAT implementation reduces production lead times.
PAT requires data systems to store the results of the tests conducted throughout the manufacturing process. PAT also requires a specialized workforce to develop more robust processes, and extract information from the process data. These requirements are opportunities in advanced pharmaceutical manufacturing.
The continuous advances in automation and information technology, availability of more economic data storage systems, improvements in electronic audit trail capabilities over paper records have compelled the industry to rethink GMP controls.
A great consequence of the above is a higher awareness of the need to establish and maintain effective dataintegrity controls at every stage of the manufacturing process.
In this year’s Transforma event, I will be sharing experiences and case-studies on how and why integrating Quality Risk Management principles to Data Integrity and Data Governance enable data controls commensurate to the level of impact to product quality of a piece of data (or data sets).
The concepts we’ll discuss have a high degree of alignment with documents published by regulators such as MHRA, PIC/S, WHO, OECD (guidance and advisory documents on GLP) and EMA.
Employing these practices help us achieve compliance with applicable laws, regulations, and directives for pharmaceutical products such as APIs, solid or oral dosage forms, sterile injectable, biologics and vaccines.
Digital transformation has a dramatic impact on the people, the culture and the human dynamics that enable business success. Understanding the connection between the human factors and how these affect the strategy, as well as the speed, effectiveness, and the sustainability of its implementation, is of up most importance in today’s competitive environment. Join us in an exploration of the human side of digital transformation and get valuable insights on:
- Connection between strategy, culture, and technology.
- The demands of a new leadership mindset for the digital age.
- Impact of engagement, inclusion, and diversity.
- How to transform the people that will make digital transformation happen.
Life Sciences companies are making digital transformation a top priority in the manufacturing processes. Implementation and integration of technology is needed to drive significant benefits to these organizations. Some of these benefits are:
- Improving product quality assurance and data integrity.
- Empowering employees by providing them the technology to make assertive decisions.
- Data access across the organization for agile decision making.
- Increasing efficiency, reducing cost and improving lead-times.
The path to Digital Transformation is long and has an impact on every business function.
Augmented Reality (AR) is transforming our day-to-day society. Enterprise companies are embracing this technology to transform the workforce into an intelligent workforce and increase productivity by integrating wearable and mobile software into their operational workflow.
Transforma 2022 allows you to learn about this breakthrough technology and applications to empower society, employees and the ecosystem of the Life Science Industry by removing knowledge boundaries through AR Technology.
Pharma 4.0™, will connect everything, creating new levels of transparency and adaptivity for a digitalized plant floor. This will enable faster decision-making and provide in-line and in-time control over business, operations, and quality. It will also require higher levels of security, since connected systems heighten vulnerability. (source ISPE) Learn more at Transforma 2022 Symposium
Learn how the local Life Science Industry ecosystem can support IPR's (Invest Puerto Rico) efforts to rebuild island's brand, attract new businesses and strengthen the relationships with existing companies.
