- TypeSeminar
- Location Philadelphia, Pennsylvania, United States
- Date 05-11-2019 - 06-11-2019
Education/Teaching/Training/Development
Medical/Healthcare/Hospital
In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle:
Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
Why you should attend:
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 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.
Although established for the pharmaceutical industry, it also provides a useful framework for other industries.
Analyses in this course use the point-and-click interface of JMP software by SAS.
Areas Covered in the Session:
Who Will Benefit:
This seminar is designed for pharmaceutical and biopharmaceutical professionals who are involved with product and/or process design, validation, or manufacturing/control.
Netzealous LLC DBA - Globalcompliancepanel 39658 Mission Boulevard, Fremont, CA 94539, USA Phone: +1-800-447-9407 Email: [email protected]
18004479407