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.
Since starting with ISPE, Edyna Miguez, has had the incredible opportunity to connect with women across the globe working within the pharmaceutical industry, as part of the ISPE Women in Pharma® program. The tenure of these rising female leaders varies, as do their cultural backgrounds. However, one fact remains consistent: they are looking to make the industry a more equitable and...
The ISPE GAMP® 5 Guide (Second Edition) was published on 29 July 2022. It was presented and discussed at the 2023 ISPE Europe Annual Conference, the 2023 ISPE Annual Meeting & Expo, and at several local...
The importance of the 2024 ISPE Europe Annual Conference is evident with the continuous challenges the pharmaceutical industry is facing in terms of drug shortages, regulatory requirements, digitalization, automation, and big data management.