The use of digital information in clinical trials has evolved and expanded rapidly in recent years, raising concerns about data integrity, patient safety, and patient privacy, while also prompting new requirements by regulatory bodies. In response, ISPE has released the

The 2024 ISPE Annual Meeting & Expo, taking place 13 – 16 October in Orlando, Florida, USA, and virtually, stands out as a key event in the pharmaceutical industry. Known for its rich educational offerings, the annual event serves as a dynamic platform where professionals gather...

The proliferation of digital tools available in the pharmaceutical industry, including artificial intelligence (AI) and machine learning (ML), is revolutionizing drug discovery and manufacturing processes.

Think of implementing a digital validation tool (DVT) as being similar to building a new house. There are decisions that need to be made before starting to build a house:

The pharmaceutical industry is on the verge of a profound transformation, driven by the digital advancements of Pharma 4.0™. This shift is set to redefine the design and construction of interconnected facilities, streamlining operations and optimizing production like never before. At this year's

This blog post will discuss the relationship between large systems that manage records at the multi-batch, multi-site level of operation and the data integrity of those records. There are several aspects to consider and they are specific to this type of environment. <

Takeda Austria GmbH has been recognized as the 2024 ISPE Facility of the Year Awards (FOYA) Category Winner for Operations.

In the ever-evolving landscape of the pharmaceutical industry, staying ahead of the curve is not just an advantage—it's a necessity. With rapid advancements in technology, regulatory shifts, and emerging global challenges, professionals need a platform to learn, network, and innovate. This year's

Supply resiliency for pharmaceutical manufacturing has been a topic of increasing interest to global stakeholders (Figure 1), resulting in widespread attention and many perspectives on how to improve drug shortages and associated vulnerabilities in the drug supply chain. At its core, supply resiliency is the ability for a manufacturer to have the agility, capacity, quality maturity, and risk...

Building on last year’s successful collaboration, AstraZeneca is once again stepping up to support ISPE’s Women in Pharma^® by sponsoring Women in Pharma® Monday Night Networking Event at the

In the rapidly evolving pharmaceutical landscape, artificial intelligence (AI) has been hailed as having the potential to revolutionize everything from drug discovery to pharmaceutical manufacturing. As the industry seeks to further explore and invest in potential opportunities for improvement and growth with AI, pursuing a thoughtful and informed approach to AI strategy planning becomes...

Any validation or quality professional working in life sciences or other highly regulated industries must possess a thorough understanding of data integrity, its regulatory requirements, and the acronym commonly associated with it: ALCOA. Even those who consider themselves well-versed in the subject may be surprised to encounter an emerging concept: ALCOA++. This expanded framework (denoted by...

At the 2024 ISPE Biotechnology Conference, which took place on 17 - 18 June in Boston, Massachusetts, USA, ISPE Women in Pharma^® hosted a compelling panel discussion titled "Beyond Boundaries: AI-Driven Efficiency in Modern Workspaces." The session -- designed and led...

The 2024 ISPE Annual Meeting & Expo, taking place 13 – 16 October in Orlando, Florida, USA and virtually is set to be a landmark gathering for pharmaceutical engineering professionals. This year’s meeting is packed with workshops designed to equip industry...

ISPE Women in Pharma^®’s dedication to diversity, equity, and Inclusion isn't just about aspirations: it’s about action. Mentor ISPE, launched in 2023 by members for members, is a testament to this commitment. Over the past two years, more than 700 professionals from around the world have joined ISPE on this journey, and as Mentor ISPE approaches its third year, the team invites ISPE...

The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the latest trends, technologies, and best practices shaping the future of pharmaceutical engineering. This year, 13-16 October in Orlando, Florida, USA, ISPE has curated a diverse...

Miriam Kremer-van der Kamp is the Business Developer at VILS Switzerland GmbH and an active ISPE member with the ISPE Germany/Austria/Switzerland (DACH) Affiliate, ISPE Women in Pharma, and ISPE Emerging Leaders. In this interview, conducted by Edyna Miguez, Membership Growth Manager at ISPE, Kremer-van der Kamp weighs in on why she joined ISPE, the benefits she’s experienced thus far, and...

What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to do with each other?