Risk‑Based Monitoring (RBM) represents a proactive and systematic approach to clinical trial oversight, shifting away from ...
Data integrity is a hot topic for regulators and auditors, making it important to understand data integrity criteria for the laboratory – and apply the principles correctly. A free on-demand webinar ...
The FDA’s 21CFR part 11 guidance on the use of electronic records for data retention or submission is clear. With manually implemented Standard Operating Procedures for Quality Control testing and ...
DUBLIN--(BUSINESS WIRE)--The "6-Hour Virtual Seminar on A Risk Based Approach To Data Integrity" webinar has been added to ResearchAndMarkets.com's offering. This course will provide the attendees ...
FALLS CHURCH, Va., March 18, 2019 /PRNewswire-PRWeb/ -- Pharmaceutical Data Integrity 5 Steps to Build a Quality Culture **An FDAnews Webinar** Tuesday, April 2, 2019 ...
FALLS CHURCH, Va., May 31, 2019 /PRNewswire-PRWeb/ -- Spreadsheet Validation Tools and Techniques for Data Integrity **An FDAnews Webinar** Thursday, June 13, 2019 ...
The rapid increase in CRISPR-mediated cell and gene therapies in clinical trials over the past few years is a testimony to the promising future of next-generation medicine. In this third and final ...
Data integrity with its "ALCOA+" is the new buzz-word. But what is it, really? And how do we get there? The presentation will first clarify what data integrity is, with the explanation of ALCOA+ ...
Cell-based chimeric antigen receptor (CAR) T cell therapies have rapidly advanced in recent years, with a variety of targets in clinical research and several FDA approved products already on the ...