Fantastic, isn’t it! Information technologies are evolving at such a pace that it seems there is something new to be excited about almost every week. This week’s headlines: MIT has announced artificial intelligence software that can see people through walls, virtual reality is being used for health and safety training, and a study claiming a chatbot has better diagnosis accuracy that human physician.
In our sector, just as with the chatbot diagnosis system, it is clear these new technologies also create new risks and new challenges. Like self-driving cars, which are forcing us to reconsider fundamental questions of accountability and safety decision making – we need to understand the risks and adapt our strategies for using and controlling these technologies around those risks.
GAMP5® is ten years old - older than many of the technologies that are finding their way into the regulated life sciences sector, and definitely older than our understanding of many of the risks we now have to deal with.
So – is it still relevant?
My answer is a resounding Yes! GAMP5® was written to be a flexible and adaptable framework for ensuring compliance of all types of computerized system, with risk management at its heart.
This year, the 2018 ISPE Annual Meeting & Expo track on Information Systems will focus on new technologies and new risks. We will build on the themes of previous years and explore the opportunities new technologies are offering and how the principles of GAMP guidance can be applied.
Our theme for the Information Systems track is “Realizing Transformational Technologies in Our Regulated World” and we are very excited to have sessions covering the following topics:
I look forward to meeting you in Philadelphia this November at the 2018 ISPE Annual Meeting & Expo – come and join us as we explore what the future holds.
As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...
At the 2024 ISPE Europe Annual Conference, held in Lisbon, Portugal, 16-18 April, Richard L. Friedman, MS, Deputy Director of the US Food and Drug Administration’s (US FDA) Office of Manufacturing Quality, in...
Insight from Austria’s Regulatory Authority Representative
At the 2024 ISPE Aseptic Conference, held March 12-13 in Vienna, Austria, Christina Meissner, a European Union Good Manufacturing Practice (GMP) inspector at the Austrian Agency for Health and Food Safety since 2013, and Chair of the PIC/S Drafting Group on Annex 2A and 2B, published in May 2021, offered a presentation titled...