Applied Statistics for FDA Process Validation 2017

  • 1295.00 Dollar US$
  • Published date: July 14, 2017
    • Baltimore, MD, Baltimore, MD, United States


Course "Applied Statistics for FDA Process Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

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. This knowledge and understanding is the basis for establishing an approach to control of a manufacturing process that results in products with desired quality attributes:




Location: Baltimore, MD Date: September 18th & 19th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090
Price:

Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
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