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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
Novatek International News Updates - 1 CFR Part 11 Compliant - Out-of-the-box LIMS software solutions

August, 2010
Northrop Grumman, VA, USA and Novatek
Northrop Grumman goes live with Novatek International CPM ...

July, 2010

Endo Pharmaceuticals, PA, USA
Endo Pharmaceuticals Goes Live with Novatek's Environmental Monitoring Software...

June, 2010
Mission Pharmacal, Texas, USA
Mission Pharmacal has chosen Novatek’s Stability LIMS software solution...

Novatek International Events Updates - 1 CFR Part 11 Compliant - Out-of-the-box LIMS software solutions
Prepare for "FDA Inspection" Review Recent Warning Letters- Aseptic Processes
June 28-29, Philadelphia, PA
Principles of "Cleaning Validation" A "How To" for a cGMP Compliant Cleaning Program
June 28-29, Philadelphia, PA
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