By David W. Vincent B.Sc., MPH, Ph.D. Introduction The pharmaceutical and biotechnology industries are highly regulated sectors that require strict adherence to cleaning and sanitization protocols to ensure product quality, safety, and compliance with regulatory requirements. Routine monitoring of cleaning processes is essential to verify the effectiveness of cleaning procedures and prevent contamination that could … Read more

Fred Ohsiek and David W. Vincent , B.Sc., MPH, Ph.D How to Perform Cleaning Validation Optimization Introduction There are three stages in the process validation lifecycle (process design, process qualification, and continued process verification) [1]. The first stage, process design, is challenging for pharmaceutical and biopharmaceutical firms to plan and execute on time. In particular, … Read more

  The implementation and validation of AI (Artificial Intelligence) technology into Robotic Process Automation (RPA) machines for fabrication, assembly, inspection, and release of medical device products. The following is a case study of VTI Life Sciences capabilities and experience in supporting our client from taking a Manual Medical Device assembly and inspection process and transforming … Read more