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UID:2140535:Event:65704
DTSTAMP:20260523T170745Z
SUMMARY:2-day In-person Seminar on Using Statistical Methods for ICH G
 uidelines at Sydney, Australia
DESCRIPTION:Overview:\nThis hands-on course will provide attendees wit
 h an understanding of how to apply statistical methods to the ICH Q se
 ries guidelines. The course will deliver tools, templates and insight 
 that will allow participants to immediately begin implementation withi
 n their organization/firm.  This 2 day hands-on workshop explores the
  unique challenges facing all facts of a pharmaceutical or biotechnolo
 gy company. \nAreas Covered in the Session:\n\nIntroduction to ICH Q 
 Series\nIntroduction/Fundamentals - Statistics\nIntegrating Statistics
  into protocols\nDeveloping a risk strategy\nQuality Managers\nAssay D
 evelopment Scientists\nQuality Analysts\nResearch Scientists\nRisk Man
 agers\nQuality Managers\n\nAgenda\nDay One:\nLecture 1: Introduction/F
 undamentals - Statistics\n\nSummary Statistics\nGraphical Techniques\n
 Hypothesis Testing\nConfidence Intervals and Tolerance Intervals\nInte
 ractive Discussion/Questions\n\nLecture 2: ICH \"Q\" Series\n\nQ1 Stab
 ility Testing\nQ2 Validation of Analytical Procedures\nQ3 Impurities i
 n New Drug Substances\nQ5 Viral Safety Evaluation of Biotechnology Pro
 ducts Derived from Cell Lines of Human of Animal Origin\nQ6 Specificat
 ions\nQ7 GMP for API\nQ8 Pharmaceutical Development\nQ9 Quality Risk M
 anagement\nQ10 Pharmaceutical Quality System\n\nDay Two:\nLecture 3: I
 ntegrating Statistics\n\nRegression - Q1\nDesign of Experiments and AN
 OVA - Q8\nSample Size - Q6\nProbability - Q9\nInteractive Discussion/Q
 uestions\n\nLecture 4: Statistical Tools in Action\n\nDeveloping a Ris
 k Management Plan\nAssay Validation\n\nLecture 5: Setting Specificatio
 ns\n \nInstructor Profile:\nMr. Walfish is a Principal Statistician 
 at BD in Franklin Lakes, NJ. He is responsible for supporting continuo
 us improvement efforts and process development for worldwide operation
 s. Prior to BD he was a statistician at GE Healthcare in Waukesha, WI.
  Previously, Steven was President of Statistical Outsourcing Services,
  a consulting company that provides statistical analysis and training 
 to the FDA regulated industries.\nLocation: Sydney, Australia     
    Date: June 11th & 12th, 2015        Time: 9 AM to 6 PM 
  Venue: WILL BE ANNOUNCED SOON – Zip Code: 17200\n \nPrice: $1,595
 .00\n(Seminar for One Delegate)\nRegister now and save $200. (Early Bi
 rd)\nUntil April 30, Early Bird Price: $1,595.00\nFrom May 01 to June 
 09, Regular Price: $1,795.00\nRegistration Details:\nNetZealous LLC,\n
 DBA GlobalCompliancePanel\n161 Mission Falls Lane,\nSuite 216, Fremont
 , CA 94539, USA         \nUSA Phone: 1-800-447-9407\nFax: 302
 -288-6884\nsupport@globalcompliancepanel.com          \nhttp
 ://www.globalcompliancepanel.com\nEvent Link - http://bit.ly/Seminar-o
 n-Using-Statistical-Methods-for-ICH-Guidelines-at-Sydney-Australia\n\n
 For more information visit https://medtechiq.ning.com/events/2-day-in-
 person-seminar-on-using-statistical-methods-for-ich-1
DTSTART;TZID=America/New_York:20150611T090000
DTEND;TZID=America/New_York:20150612T180000
CATEGORIES:food, fda, medical, device, defence, and, navy, aerospace, 
 mining
LOCATION:Sydney, Australia
WEBSITE:https://www.globalcompliancepanel.com
URL:https://www.globalcompliancepanel.com
CONTACT:18004479407
ORGANIZER:GlobalCompliancePanel
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011438?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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