Data integrity has been and continues to be an inherent aspect of global GMP regulations governing electronic and paper-based records in pharmaceutical manufacturing.
Cover: Data integrity has been and continues to be an inherent aspect of global GMP regulations governing electronic and paper-based records in pharmaceutical manufacturing.
Feature: As key developments unfold in its health care system, South Africa’s pharmaceutical workforce needs a plan for agile skills development and retention strategies.
Feature: Lean innovations in medical technology can help provide more information, personalized tools, and better methods for promoting wellness in African countries.
Pharmaceutical Engineering magazine’s March–April 2016 Special Report1 highlighted the increasing...
Over 2,000 attendees from more than 28 countries gathered in Philadelphia for the 2018 ISPE Annual Meeting & Expo on 4–7 November. Highlights below show the many ways that presenters captured the conference theme of...
Happy 2019! The last time I saw many of you was at the ISPE 2018 Annual Meeting & Expo in Philadelphia, where I started my tenure as the ISPE International Young Professionals Chair.
Maritime discipline took the Boston Area Chapter President from a trawler to the boardroom. - It might seem odd to connect commercial fishing to the study of chemical engineering— and perhaps even more unlikely to connect commercial fishing to a career in the biopharmaceutical industry. But for Kevin Chronley, Vice President...
Across industries, the trend is toward speed to market. - Whether it’s meeting consumer expectations for instant service or being the first to bring an innovation to shelves, companies have plenty of incentives to make products and services available faster.
The 2018 ISPE Quality Manufacturing Conference, held 4–6 June 2018 in Arlington, Virginia, included a well-attended session entitled “Data Integrity—Beyond the Lab,” which reaffirmed continued focus...
Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity requirements. Regulators and health agencies are strongly enforcing data integrity related...
The Fourth Industrial Revolution could completely transform health care.
Record-setting 1,000 participants from 25 countries
This article discusses how blockchain technology may disrupt the way we collect and manage data within regulated processes. The first section is a nontechnical summary of blockchain’s features, including a description of what it is (and what it is not). This sets the context for the next section, in which we discuss several blockchain use cases currently being piloted by life sciences...
This article presents an adaptation of clinical trial management to ICH E6 (R2). A case study assesses quality risks in a clinical data management system.
