Quality by Design using Design of Experiments (QbD)

Quality by Design using Design of Experiments (QbD) in Tukwila on 02 February 2017
Quality by Design using Design of Experiments (QbD) in Tukwila on 02 February 2017
02 February 2017 -- 03 February 2017, 0900 - 1800
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.
Although the seminar focuses on the use of DOE for QbD, multiple aspects of QbD are integrated into the course. After learning the relevant applied statistics, participants will understand how statistics can be used to help set specifications and analyze measurement systems, two foundational requirements of QbD. Next participants will learn tools to help them

On Thursday February 2, 2017 at 9:00 am (ends Friday February 3, 2017 at 6:00 pm)

Category: Exhibitions - Engineering & Technology - Computer & IT

Price:

One Delegate Without Stay: USD 1295.00
Five Delegates Without Stay: USD 3885.00

Venue: Courtyard Seattle Sea-Tac Area, 16038 West Valley Highway, Tukwila, 98188

Links:

Tickets: https://go.evvnt.com/80883-0
Starting Price Per Person
$ 1295.00 USD
Other Information
Where
Courtyard Seattle Sea-Tac Area
16038 West Valley Highway
Tukwila 98188
United States

                 
Event Organizer Contact
Marilyn Turner
marilyn.turner@nyeventslist.com
+1 929 900 1853
More Events
Event ID: 83232

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