The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: May 17, 2018 at 9am to May 18, 2018 at 6pm
Location: DoubleTree by Hilton Philadelphia Airport
Street: 4509 Island Avenue, Philadelphia, PA 19153
Website or Map: http://www.globalcompliancepa…
Event Type: seminar
Organized By: John Robinson
Latest Activity: Apr 12
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: Philadelphia, PA Date: May 17th & 18th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153
Price: $1,295.00 (Seminar Fee for One Delegate)
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Until April 10, Early Bird Price: $1,295.00 From April 11 to May 15, Regular Price: $1,495.00
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