Newsletter | September 15, 2021

09.15.21 -- Applying Effective Quality Risk Management To Filter Integrity Testing

Data Integrity And Data Access Control For Filter Integrity Test Instruments

Assuring the integrity of critical records when generating and maintaining them is essential to the development and production of high-quality, safe, and effective drugs. This technical paper reviews the evolving regulatory requirements and standards for data integrity and how they can be applied to filter integrity test instruments.

Addressing The Training Gap For Single-Use Technologies

Gaps in employee and contractor training remain one of the top reasons that drug manufacturers fail cGMP compliance inspections by regulatory authorities. As the adoption of single-use technology (SUT) grows, effective training can achieve rapid SUT knowledge transfer to ensure successful and reliable operation in a cGMP-compliant process. This article reviews how a blended training approach of face-to-face, e-learning, virtual classrooms, and virtual and mixed reality training is the best way to achieve training goals.

13 Points To Consider When Selecting A Filter Integrity Test Instrument

Choosing the right filter integrity test device, tailored to your needs, can be a difficult task. Process needs for filter integrity test instruments have changed over the years as regulations, technologies, and best practices have evolved to improve patient safety. This infographic gives 13 points to consider before you choose your next instrument focusing on design, function, automation, and compliance.