The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: April 6, 2017 at 9am to April 7, 2017 at 6pm
Location: Baltimore, MD
Street: The DoubleTree Baltimore-BWI Airport
City/Town: Baltimore, MD
Website or Map: http://www.globalcompliancepa…
Event Type: quality, by, design, using, of, experiments, (qbd), 2017
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Mar 2, 2017
Course "Quality by Design using Design of Experiments (QbD)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion
This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.
Using a QbD approach for pharmaceutical development studies should include a systematic understanding of the process and using this understanding to establish a control strategy as part of a comprehensive quality risk management program.
This systematic understanding should include both identification of significant process parameters and determination of a functional relationship (mathematical model) linking these significant process parameters to the critical quality attributes (CQAs). The original guidance document on pharmaceutical development provides general guidance on how these are identified: gaining knowledge about which variation in factors explains variation in product quality characteristics of drug product. It also provides a means to achieving this knowledge: through the use of formal experimental designs. The use of DOE methodology provides a means to identify those factors that impact product quality characteristics of drug product (or significant process parameters) and determine the functional relationship that links the process parameters to the CQAs.
Location: Baltimore, MD Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: The DoubleTree Baltimore-BWI Airport
Address: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until February 28, Early Bird Price: $1,295.00 from March 01 to April 04, 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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