Complimentary Learning Level: Intermediate/Advanced Session Length: 1.5 hours Process validation stage 1, also known as process characterization (PCS), is the main step of generating process knowledge that is reported in...
Lifecycle Process Validation guidance has been published by FDA in 2011 and by PIC/S and EMA in 2015. This guidance reflects ICH guidance on enhanced development and product quality monitoring practices using approaches...
Online Live Overview Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should I make? Are we taking enough samples? Do we...
ISPE training instructor, Maurice Parlane, B Tech MIT, New Wayz Consulting Ltd., CBE Pty Ltd., shares the top three takeaways you will gain by attending ISPE process validation training. Register Now For even more on...
Guide contributor (co-lead) Robert Beall, PMP, ProPharma Group, shares why process validation is an essential part of the pharma industry and how you’ll benefit from the ISPE Good Practice Guide: Practical Implementation...
Continuous manufacturing (CM) technologies have recently been implemented in the pharmaceutical industry for process development, clinical trials, and commercial supply. This article is a high-level summary of a recently published
ISPE announced the release of their latest guide, ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation . This guide provides professional insights for fundamental principles, process lifecycle approaches...
