The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: April 20, 2017 at 9am to April 21, 2017 at 6pm
Location: San Diego, CA
Street: Four Points By Sheraton San Diego Downtown 1617 1st Avenue - San Diego, California, 92101 - United States
City/Town: San Diego, CA
Website or Map: http://www.globalcompliancepa…
Event Type: applied, statistics, for, fda, process, validation, 2017
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Mar 2
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.
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: San Diego, CA Date: April 20th & 21st, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Four Points by Sheraton San Diego Downtown
Address: 1617 1st Avenue - San Diego, California, 92101 - United States
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until March 15, Early Bird Price: $1,295.00 From March 16 to April 18, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00
$6,475.00 You Save: $2,590.00 (40%)*
NetZealous DBA as GlobalCompliancePanel
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