Date: May 16, 2017
Time: 12:00-1:00 PM Eastern
Instructor: W. Heath Rushing, Adsurgo
Registration: Sign up at below and Adobe Connect link will be provided
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. Although established for the pharmaceutical industry, it also provides a useful framework for other industries. This course 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. Analyses in this course use the point-and-click interface of JMP software.
- • Stage 1 – Process Design
- • utilize risk management tools to identify and prioritize potential critical process parameters
- • define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE).
- • develop a control plan as part of a risk management strategy
- • Stage 2 – Process Qualification
- • assess scale effects while incorporating large (pilot) scale data
- • develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies
- • Stage 3 – Continued Process Verification
- • collect and analyze product and process data
- • ensure your process is in (statistical) control and capable.
- • Guidance on the need for statistical methods in process validation for pharmaceuticals.
- • Statistical Methods in Stage 1 – Process Design.
- • Statistical Methods in Stage 2 – Process Qualification
- • Statistical Methods in Stage 3 – Continued Process Verification