Read, Learn, Innovate: Top Blog Posts from August 2019
Featured in this edition of ISpeak Reading Roundup, are the top blog posts from August 2019. Discover key insights for data integrity, manufacturing excellence, innovative validation practices, and more for what the pharmaceutical industry was reading last month.
Industry tools for risk management and data-based decision making have become more progressive with the use of visual process mapping and multidimensional datasets. Learn more about how to leverage these tools in the presentation of quality data for pharmaceutical and medical devices in today’s facilities.
Hear from Charlie C. Wakeham on professionally reviewed instruction featured in the ISPE GAMP® Data Integrity for Manufacturing Records guide. The guide focuses on data Integrity and the importance of critical thinking for protection of laboratory data and records at every stage of the product lifecycle.
See the industry excel with Moderna, Inc. and their application of modern technologies, innovative solutions, and progressive facility concepts. Their new facility in Norwood, MA will help eliminate supply chain risks and solidify their commitment to patients in providing life-saving medicines.
Risk for contamination and regulatory violations decrease with an analysis of common mistakes and redesigned maintenance procedures. Read about the necessary planning, pre-requisites, and challenges that interfere with approved cleaning validation practices.
Explore a plan for continued process verification and the crucial parameters and attributes necessary for successful GMP bioprocess. This plan at its core evaluates close attention to statistical accuracy and managing process vulnerabilities.
A committee under the auspices of the National Academies of Sciences, Engineering, and Medicine (NASEM) is conducting a study with the aim of producing a consensus report that identifies emerging and upcoming technologies that have the potential to...
In response to the COVID-19 pandemic, several governments are considering legislation or regulatory actions that would require some or all parts of a drug product’s supply chain, e.g., Active Pharmaceutical Ingredients (APIs) and biotherapeutic drug...
As we sat down to write the this blog for iSPEAK to promote the 2020 ISPE Annual Meeting & Expo we wanted to look back over what has happened in the world in the first half of 2020 and to say it has been one for the history books is an understatement, it...