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DESCRIPTION:This 2-day seminar explores the unique challenges facing quali
 ty functions of pharmaceutical and biotechnology companies. Attendees wil
 l learn practical implementation solutions as well as best practice descr
 iptions that will allow management to effectively assess\, manage and mit
 igate risk of poorly designed studies. Participants will learn statistica
 l methods related to ICH guidelines and will discover how regulatory agen
 cies\, such as the FDA expect organizations to meet these guidelines.\n\n
 This seminar will provide attendees with an understanding of the fourteen
  ICH Quality guidelines as relates to statistical guidance and analysis. 
 The course will provide tools\, techniques and insight that will allow pa
 rticipants to immediately begin implementation of the information learned
  within their organization/firm\n\nLearning objectives:\nUpon completion 
 of the course\, you will be able to:\n\n\nCompare FDA requirements to ICH
  guidelines.\nPerform comparative analyses and regression analysis.\nKnow
  the difference between confidence and tolerance intervals.\nCalculate th
 e appropriate sample size.\nCalculate the probability of risk.\nDesign an
 d perform statistical tests for comparisons\, stability\, validation\, im
 purities\n\nAreas covered:\nDay 1: ICH review and Statistics Fundamentals
 \n\n\nReview ICH Quality Guidelines (Q Series)\n\nQ1 Stability Testing\nQ
 2 Analytical Validation\nQ3A-3E Impurities\nQ4 Pharmacopoeias\nQ5A-5E Qua
 lity of Biotechnological Products\nQ6A-6B Specifications\nQ7 Good Manufac
 turing Practice\nQ8 Pharmaceutical Development\nQ9 Quality Risk Managemen
 t\nQ10 Pharmaceutical Quality System\nQ11 Development and Manufacture of 
 Drug Substances\nQ12 Lifecycle Management\nQ13 Continuous Manufacturing o
 f Drug Substances and Drub Products\nQ14 Analytical Procedure Development
 \nDeveloping a Quality Risk Management Plan\n\nFundamentals of Statistics
 \n\nNormal Distribution\nDescriptive and Summary Statistics\nGraphical Te
 chniques\nNull Hypothesis Statistical Testing\nConfidence and Tolerance I
 ntervals\nStatistical vs. Meaningful Significance\n\n\nDay 2: Statistical
  Tests and Applications to Industry\n\n\nStatistical Analyses\n\nComparat
 ive Statistics\nRegression Analysis\nSample Size (Power Analysis)\nDiscus
 sion/Questions\n\nApplication to Industry\n\nDesign of Experiments (DOE)\
 nSetting Specifications/Thresholds/Acceptance Criteria\nStability/Shelf-L
 ife Testing\nAssay Validation\nImpurities\nDiscussion/Questions\n\n\nWho 
 will Benefit:\n\nQuality Managers\nAnalytical Validation scientists and p
 ersonnel\nAssay Development Scientists\nQuality Control Personnel\nQualit
 y Analysts\nResearch Scientists\nRisk Managers\n\n&nbsp\;\n
DTEND:20251204T140000
DTSTAMP:20260514T150018Z
DTSTART:20251203T090000
LOCATION:\,
SEQUENCE:0
SUMMARY:This 2-day seminar explores the unique challenges facing quality f
 unctions of pharmaceutical and biotechnology companies. Attendees will le
 arn prac...
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