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DTSTART:19700308T020000
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UID:2140535:Event:66029
DTSTAMP:20260522T101949Z
SUMMARY:Webinar On Method Validation: Utilizing Quality by Design (QbD
 ) and Risk in Implementation
DESCRIPTION:Description :\nPharmaceutical industry is experiencing a g
 rowing need to improve performance driven by global competition and th
 e increasing impact of information technology. FDA’s Process Validat
 ion Guidance calls for continued process verification which applies to
  both manufacturing and measurement processes. How to go about this im
 provement in a systematic, focused and sustainable manner is the quest
 ion. Fortunately a world-class body of improvement technology exists k
 nown as Quality by Design (QbD); a science and data-based approach tha
 t builds quality into products and processes during development, valid
 ation and operations.\nA characteristic of good science is good data. 
 Quality data are arguably more important today than ever before. Using
  a series of case studies and examples it will be shown how QbD can be
  integrated into a holistic approach that can be used to effectively d
 esign and improve laboratory processes enabling prompt, successful met
 hod validation. Methods discussed in this session include assessment o
 f method design, repeatability and reproducibility, improving method r
 obustness and measurement process control. Methods for assessing that 
 amount of product variation that can be attributed to the manufacturin
 g process, sampling procedures and test method are also presented. The
  concepts and methods involved will be introduced and illustrated with
  pharmaceutical and biotech case studies and examples.\nAreas Covered 
 in the Session :\nParticipants in the webinar will learn how to improv
 e test method performance by:\nRapid design and development of test me
 thods using statistical design of experiments\nImproving measurement q
 uality using Gage Repeatability and Reproducibility studies\nDevelopin
 g measurement systems that are robust to variations in method use\nCon
 trolling measurement variation by using control samples and statistica
 l process control techniques\nIdentifying how much of the total variat
 ion is due to the manufacturing process, the sampling procedure and th
 e test method\nWho Will Benefit:\nExecutives and Managers engaged in P
 harmaceutical and Biotech Research and Development\nQuality Assurance 
 Personnel\nRegulatory Affairs Professionals\nTest Method Development a
 nd Validation Personnel\nQuality Engineers\nProcess and Manufacturing 
 Engineers\nResearch and Development Scientists\nOperations Excellence 
 Professionals\nBiologists and Microbiologists\nChemists and Chemical E
 ngineers\nAnyone with a desire to learn the fundamentals of methodical
  performance improvement\nPrice tags:\nLive\nSingle Live : For One Par
 ticipant\n$ 249\nCorporate Live : For Max. 10 Participants\n$ 899\nRec
 ording\nSingle REC : For One Participant - Unlimited Access for 6 Mont
 hs\n$ 299\nFor more information and enquiries contact us at\nComplianc
 e Trainings\n5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  
 Customer Support : #416-915-4458  Email : support@compliancetraining
 s.com\nFor more information about this event please visit\nhttps://com
 pliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1431\nLik
 e Us On Facebook:\nhttps://www.facebook.com/events/798196543567032/\n\
 nFor more information visit https://medtechiq.ning.com/events/webinar-
 on-method-validation-utilizing-quality-by-design-qbd-and
DTSTART;TZID=America/New_York:20150429T130000
DTEND;TZID=America/New_York:20150429T140000
CATEGORIES:webinar
LOCATION:Canada
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1431
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1431
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011745?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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