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UID:2856512:Event:6465
DTSTAMP:20120529T221608Z
SUMMARY:Live Online Training: FDA's New Process Validation Guidance
DESCRIPTION:Primer on Actions You Need to Begin Taking NOW    \nLiv
 e Online Training Content:\nBackground on FDA's New Guidance on Proces
 s Validation\n\nWhy did FDA upgrade the Guidance on process validation
  now?\nAlignment with ICH Q8, Q9, and Q10\nDefinition and goal of proc
 ess validation\nFormer approach compared to FDA's new approach\nStage 
 1 - Process design\nStage 2 - Process qualification\nStage 3 - Continu
 ed process verification\nNew Keys to a successful validation program\n
 Understand the sources of variation\nDetect the presence and degree of
  variation\nUnderstand the impact of variation on the process and prod
 uct\nControl the variation commensurate with risk\nGeneral considerati
 ons for process validation\nStage 1 - Process Design: Key points and p
 ractical applications for:\nBuilding and capturing process knowledge a
 nd understanding\nEstablishing a strategy for process control\n\n\nSta
 ge 2 - Process Qualification: Key points and practical applications fo
 r: \nDesign of a facility and qualification of utilities and equipmen
 t\nProcess performance qualification (PPQ)\nPPQ protocol\nPPQ protocol
  execution and report\n\n\nStage 3 - Continued Process Verification: K
 ey points and practical applications for:\nConcurrent Release of PPQ B
 atches\nDocumentation\nAnalytical Methodology\n\n\nWhat is FDA trying 
 to accomplish and what benefits can be expected from this approach to 
 process validation?\nWhat specific actions do we need to take now?\nSu
 mmary, conclusions, and final recommendations\n\nComplete Training Det
 ails - Click Here \nREGISTER TODAY in the enKap store - click here\nÂ
  \n \n\nFor more information visit http://www.enkap.com/events/live-o
 nline-training-fdas-new
DTSTART:20110224T154500Z
DTEND:20110224T170000Z
CATEGORIES:live, online, training
LOCATION:Your Computer
WEBSITE:http://enkap.com/page/live-online-training-fdas-new
URL:http://enkap.com/page/live-online-training-fdas-new
CONTACT:561-308-3093
ORGANIZER;CN=enKap:http://www.enkap.com/profile/jamessleeman
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ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=enKap:htt
 p://www.enkap.com/profile/jamessleeman
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