GlobalCompliancePanel Seminar “Applied Statistics for FDA Process Validation” successfully done in Philadelphia, PA at May 17th & 18th, 2018.

GlobalCompliancePanel have been successfully organized the 2 days seminar in Philadelphia, PA from May 17th & 18th, 2018 by NetZealous LLC.

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The Food and Drug Administration (FDA) provided a guidance for industry in 2011 that has established a framework for process validation in the pharmaceutical industry. This guidance, titled “Process Validation: General Principles and Practices” consists of a three-stage process. The three stages are 1) Process Design, 2) Process Qualification, and 3) Continued Process Verification.

This Seminar focuses on how to establish a systematic approach to implementing statistical methodologies into a process development and validation program consistent with the FDA guidance. This course teaches the application of statistics for setting specifications, assessing measurement systems (assays), using design of experiments (DOE), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

The seminars organized In Guidance for Industry Process Validation: General Principle and Practices and On the First day of the seminars which was 17th of May 2018, GlobalCompliancePanel had covered Introduction to Statistics for Process Validation, Primer on Statistical Analysis (cont.) with Mr. Heath Rushing is cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery.

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On the second day of the GlobalCompliancePanel Seminar which was 18th of May 2018, was covered Foundational Requirements for Process Validation, Stage 1 – Process Design, Stage 2 – Process Qualification and Stage 3 – Continued Process Verification with Mr. Heath Rushing is cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery.

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