This webinar will discuss the fundamentals of effective and US Food and Drug Administration-compliant process validation. The background to FDA's Process Validation: General Principles and Practices will be discussed, and the requirements will be analyzed.

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At IVT's Validation Week EU, Cliff Campbell explained the nature of identifying variables in the process validation lifecycle. As Campbell explained and demonstrated, providing visual representations of data and processes can be extremely helpful when pinpointing the different variables that continually appear in validation processes.

The Winter and Spring Issues of the Journal of GXP Compliance featured papers on technical/quality agreements, devoloping test cases, academic GLP and GCLP programs, change control, and validating the SaaS application. The following questions are adapted from papers published in the Journal of GXP Compliance and are designed to test your knowledge of the best practices for global compliance.

Questions:6
Attempts allowed:Unlimited
Available:Always
Pass rate:75 %
Backwards navigation:Forbidden
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At IVT's Validation Week EU, Dawn Tavalsky described the various global regulations that recommend variation control. Analyzing requirements for pharmaceuticals and medical devices, Tavalsky highlighted variation control from the GHTF Medical Device Process Validation Guidance, the Code of Federal Regulations, and the US Food and Drug Administration's Process Validation Guidance.

While most professionals know there are three stages of the process validation lifecycle, many are unaware of the activities dictated by each stage. As part of IVT's pre-Validation Week webinar, Paul Pluta, Ph.D., explained the prescribed endeavors of Stage 1, Stage 2, and Stage 3 of process validation as recommended by the US Food and Drug Administration.

Self-correcting organizations are companies in the GXP regulated industry that do not shy away from defects and defect discovery. As Joseph Zec explains in the following interview and recording, there are common, key characteristics of a self-correcting organization that, once adopted and implemented, will lead to global regulatory compliance.


Self-Correcting Organizations: Q&A with Joseph Zec

During a webinar led by Paul Pluta, Ph.D., the regulatory history of process validation was discussed. From the original 1987 Process Validation Guidance to the 2012 European Medicines Agency Guidance, Dr. Pluta explained every document that furthers the practice of process validation in regulated environments.

See more of Paul Pluta at IVT's Validation Week.