When most people hear “Facility of the Future,” they immediately think about robots, automation, virtual reality, or logging in with a Facebook account, security issues aside. However, when I hear “Facility of the Future,” I think of lean manufacturing and flexibility. The majority of my career has been on the design side, where I focused on building facilities. Historically, the projects I...
Knowledge Management (KM) is a discipline (akin to Quality Risk Management (QRM) or Lean Six Sigma) that focuses on how organizations create, manage, use, and share knowledge. The publication of ICH Q10 in 2008 saw the formal designation of KM as a key enabler for an effective Pharmaceutical Quality System (PQS), along with QRM. Since then, the industry has acknowledged the...
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
A thought-provoking session held during the 2021 ISPE Annual Meeting & Expo provided insight into how the Overall Quality Summary can provide an ideal opportunity to provide a...
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are some great reading selections for the holidays! This year’s holiday topic: biopharma, cell and gene therapies, and ATMPs. That topic is the theme for the November-December 2021 issue , and here are some earlier articles on these important and timely topics.
