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.. [email protected] 5 20-23 2012
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. . . . . (Quality by Design).
. . : .
. . ( )
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http://www.smh.com.au/national/tribunals-judge-morals-over-errors-as-negligent-doctors-escape-bans-20120725-22qxv.html
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1999.
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W.A SHEWART : 1931. Economic Control of Quality of Manufactured
Product (1931). .
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, .
Quality has to be the fabric of the organization, not part of
the fabricQuality has to be caused,not controlled ... , .
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Quality is everyone's responsibilityIf you can't describe what
you are doing as a process, you don't know what you're doingYou can
not inspect quality into the product; it is already thereDoes
experience help? NO! Not if we are doing the wrong thingsWe should
work on our process, not the outcome of our processesRational
behavior requires theoryLack of knowledge . . . that is the
problemLearning is not compulsory... neither is survival ---
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() () . . . . .
A system is an entity which maintains its existence through the
mutual interaction of its parts.Ludwig von Bertalanffy
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THE DRIP SYNDROME DATA RICHIFORMATION POOR
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Know WhyKnow How
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http://www.psychometric-success.com/emotional-intelligence/emotional-intelligence-in-business.htm
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.
.,2005Montgomery,1998http://notalwaysworking.com/if-you-are-unhappy-for-any-reason/25538
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ALL WORK IS A PROCESSPROCESSES ARE VARIABLEANALYSE PROCESS
VARIATIONDEVELOP PROCESSKNOWELEDGEIMPROVED QUALITYREDUCE COMMON
CAUSE VARIATION REDUCE SPECIAL CAUSE VARIATIONCHANGE PROCESSCONTROL
PROCESSSPC DOESnee,1990
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If you can't describe what you are doing as a process, you don't
know what you're doing. W.E.Deming A Process is a system of
Causes
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:H QUALITY BY DESIGNQUALITY BY TESTINGY= f (X1,X2)
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http://www.oaklandconsulting.com
http://www.pharmpro.com/articles/2012/04/-QbD-and-the-New-Process-Validation-Guidance/
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http://www.pharmpro.com/articles/2012/04/-QbD-and-the-New-Process-Validation-Guidance/
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The aim of pharmaceutical development is to design a quality
product and its manufacturing process to consistently deliver the
intended performance of the product.
The information and knowledge gained from pharmaceutical
development studies and manufacturing experience provide scientific
understanding to support the establishment of the design space ,
specifications, and manufacturing controls.
Information from pharmaceutical development studies can be a
basis for quality risk management.
It is important to recognize that quality cannot be tested into
products; i.e., quality should be built in by design.
...the applicant should demonstrate an enhanced knowledge of
product performance over a range of material attributes,
manufacturing process options and process parameters.
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf
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QualityQuality by Design (QbD)Control StrategyCritical Process
Parameter (CPP)Critical Quality Attribute (CQA)Design SpaceProven
Acceptable Range (PAR)Quality Target Product Profile (QTPP)Design
Space:The multidimensional combination and interaction of input
variables (e.g., material attributes) and process parameters that
have been demonstrated to provide assurance of
quality.http://blog.drmalpani.com/2010/08/how-medical-software-can-help-to.htmlhttp://www.leedspft.nhs.uk/news/archive_news/1/186http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002872.pdf
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DOE DOING MORE WITH LESSPROCESS KNOWLEDGE
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SPC: IS YOUR PROCESS STABLE?There is no process, no capability
and no meaningful specs, except in statistical control (Deming)
http://www.minitab.com/en-GR/default.aspx
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Quality by Design: ?
Seely L. Clinical Trial Quality-By-Design Case Study A Small
Company Experience , Workshops on Quality by Design Clinical Trials
Transformation Initiative (CTTI), February 2012
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Contact: [email protected] get free accessQUALITY BY
DESIGN: TOOLS
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PROCESS VALIDATION Contact: [email protected] get free
access
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IR Example from GPhA:
http://www.gphaonline.org/sites/default/files/ExampleQbDforIRTabletApril%2026-revised.pdf
MR Example from GPhA:
http://www.gphaonline.org/sites/default/files/DraftExampleQbDforMRTablet%20April%2026.pdf
