InTouch
On 19 October, the ISPE Foundation hosted its 2nd Annual Golf Tournament at Wildhorse Golf Course following this year’s Annual Meeting & Expo in Las Vegas.
January / February 2024
Features
Due to the growing digitalization of the industry, we are highly dependent on information technology (IT) systems and data. The basic ability to execute our pharmaceutical business and decision-making processes relies on the permanent availability of these IT systems and data to ensure compliance and efficiency of our business operations. But numerous factors—including criminal activities,...
Technical
Calibration plays a critical role in ensuring a measurement instrument’s accuracy—especially if the instrument has a direct impact on product quality and patient safety. However, the calibration process is a complex system, and the traditional analytical approach for planning this process is often not sufficient to improve service performance. Using a digital simulation model as a...
Features
Stakeholders across industries are becoming accustomed to using information technology (IT) systems, applications, and business solutions that feature artificial intelligence (AI) and machine learning (ML). Even though some of these uses show phenomenal performance, thorough risk management is required to ensure quality and regulatory compliance are met within the life sciences industry. By...
Insights
ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) outlines how to apply a risk-based approach to GxP computerized systems and is aligned with the FDA draft guidance “Computer...
Insights
An ISPE campaign in 2016 piqued my interest in the Women in Pharma committee because I’m an advocate for women in the workplace. When I became President of the ISPE Philippines Affiliate in 2017, I knew that Women in Pharma...
Technical
The biotechnology and pharmaceutical sectors have pledged to reduce greenhouse gas (GHG) emissions as the climate concerns of consumers, investors, and regulators continue to grow. In seeking to benefit from this demand for sustainability and the potential for cost-saving opportunities, life science product manufacturers have started to evaluate the climate impact of their own labs and...
Insights
Next year promises to be a busy one for ISPE. The year starts with the 2024 ISPE Facilities of the Future Conference in San Francisco and is quickly followed by the