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.
RIP Spreadsheets and Fishbones: Their Time Has Come and Gone
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.
Data Integrity for Manufacturing Records
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.
Meet Moderna, Inc. - 2019 Facility of the Future Category Winner
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.
Common Pitfalls During Implementation of a Cleaning Validation Program
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.
Continued Process Verification, 3rd Stage of FDA Process Validation Guidelines
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.
