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DTSTAMP:20260519T195355Z
SUMMARY:2-day In-person Seminar on Using Statistical Methods for ICH G
 uidelines at Barcelona, Spain
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. Practical implementation solutions as well as best practic
 e descriptions that will allow management to effectively assess manage
  and mitigate risk of poorly designed studies. \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 Development Scientists\nQuality Anal
 ysts\nResearch Scientists\nRisk Managers\nQuality Managers\n\nAgenda\n
 Day One:\nLecture 1: Introduction/Fundamentals - Statistics\n\nSummary
  Statistics\nGraphical Techniques\nHypothesis Testing\nConfidence Inte
 rvals and Tolerance Intervals\nInteractive Discussion/Questions\n\nLec
 ture 2: ICH \"Q\" Series\n\nQ1 Stability Testing\nQ2 Validation of Ana
 lytical Procedures\nQ3 Impurities in New Drug Substances\nQ5 Viral Saf
 ety Evaluation of Biotechnology Products Derived from Cell Lines of Hu
 man of Animal Origin\nQ6 Specifications\nQ7 GMP for API\nQ8 Pharmaceut
 ical Development\nQ9 Quality Risk Management\nQ10 Pharmaceutical Quali
 ty System\n\nDay Two:\nLecture 3: Integrating Statistics\n\nRegression
  - Q1\nDesign of Experiments and ANOVA - Q8\nSample Size - Q6\nProbabi
 lity - Q9\nInteractive Discussion/Questions\n\nLecture 4: Statistical 
 Tools in Action\n\nDeveloping a Risk Management Plan\nAssay Validation
 \n\nLecture 5: Setting Specifications\n \nInstructor Profile:\n\n Mr.
  Walfish is a Principal Statistician at BD in Franklin Lakes, NJ. He 
 is responsible for supporting continuous improvement efforts and proce
 ss development for worldwide operations. Prior to BD he was a statisti
 cian at GE Healthcare in Waukesha, WI. Previously, Steven was Presiden
 t of Statistical Outsourcing Services, a consulting company that provi
 des statistical analysis and training to the FDA regulated industries.
  \nLocation: Barcelona, Spain        Date: June 8th & 9th, 20
 15        Time: 9 AM to 6 PM  Venue: Hilton Barcelona Hotel\n
 Venue Address: Avinguda Diagonal, 589-591, 08014 Barcelona, Spain\n \
 nPrice: $2,095.00\n\nRegistration Details:\nNetZealous LLC,\nDBA Globa
 lCompliancePanel\n161 Mission Falls Lane,\nSuite 216, Fremont, CA 9453
 9, USA         \nUSA Phone: 1-800-447-9407\nFax: 302-288-6884
 \nsupport@globalcompliancepanel.com          \nhttp://www.gl
 obalcompliancepanel.com\nEvent Link - http://bit.ly/Using-Statistical-
 Methods-for-ICH-Guidelines-at-Barcelona-Spain\n\nFor more information 
 visit https://medtechiq.ning.com/events/2-day-in-person-seminar-on-usi
 ng-statistical-methods-for-ich
DTSTART;TZID=America/New_York:20150608T090000
DTEND;TZID=America/New_York:20150609T180000
CATEGORIES:food, fda, medical, device, defence, and, navy, aerospace, 
 mining
LOCATION:Hilton Barcelona Hotel
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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