Welcome to UpcomingEvents.com!! We hope to see you at an event SOON!
Search

Select Region

Featured Regions

Philadelphia, PA Baltimore, MD Atlantic City, NJ

Not what you're looking for? See All Cities

Or

Search by Zip

Applied Statistics for FDA Process Validation


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.

The first stage of process validation is process design. The Process Validation guidance document states, 'A successful validation program depends on information and knowledge from product and process development.

Read More

View Less

Top