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Novatek Medical Data Systems
EVENT DETAILS
Fundamental Tools in Statistics for GMP Compliance A Two-Day Case Studies & Workshops for Life Sciences Professionals February 2-3, 2010 - Greater New York city Area, USA

These two-day comprehensive hands on program will cover the following topics

  • Introduction and basic overview of Common Statistical Tools
  • Fundamental Tools in Statistics
  • Statistical Process Control - Pareto chart
    • Control Charts o Trending analysis
    • Control chart diagnostics
    • Design a statistically sound sampling Plan
  • Outliers
  • Applying statistics to specification Setting
  • T-test (one-sample, two-sample and paired)
  • Tolerance intervals and confidence intervals
  • Capability analysis - Cp, Cpk, Pp and Ppk
  • Implementing Design of Experiments (DOE)
  • Regression analysis
  • Interpreting a normal probability plot
  • Comparing confidence interval of parameters to p-value
  • Method Validation – ICH Q2R1 – Accuracy, Linearity, and Precision
  • Variance components
  • Statistics for Annual Product Review (APR) and how to present data
    Link: http://www.ipacanada.com/viewcourse.php?id=statstool0210nyc

NEWS:

February 2012
Abbott Vascular and Novatek
Novatek Successfully passed Abbott Vascular on site Regulatory Audit
February 2012
West-Ward Pharmaceuticals, a subsidiary of Hikma PLC – Portugal, Germany & USA
West-Ward Pharmaceuticals, a subsidiary of Hikma PLC has chosen Novatek’s microbiology environmental monitoring software program
January 2012
Novartis Animal Health Canada Inc.
Novartis Animal Health Canada Inc., an affiliate of Novartis AG has chosen Novatek’s microbiology environmental monitoring software program

EVENTS:

Pittcon Conference & Expo - Booth 1884
March 12-15, 2012 - Orlando, FL
2012 PDA Annual Meeting - Booth 512
April 16-18, 2012 - Phoenix, AZ
PDA/FDA Joint Regulatory Conference - Booth 21
September 10-12 - Baltimore, MD
PDA’s 7th Annual Global Conference on Pharmaceutical Microbiology - Booth 19
October 22-24, 2012 - Bethesda, MD
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