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quot; to establish both in-process and final specifications. The guidance documents necessitate the application of statistical methods for development and validation of measurement systems, process understanding using Quality by Design (QbD) principles, process validation, as well as ensuring the manufacturing process is in control and is capable. This course provides instruction statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries. Areas Covered in the Session: Objectives: describe and analyze the distribution of data develop summary statistics generate and analyze statistical intervals and hypothesis tests to make data-driven decisions describe the relationship between and among two or more factors or responses understand issues related to sampling and calculate appropriate sample sizes use statistical intervals to setting specifications/develop acceptance criteria use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility ensure your process is in (statistical) control and capable Who Will Benefit: This seminar is designed for pharmaceutical, biopharmaceutical, and medical device professionals who are involved with product and/or process design: Process Scientist/Engineer Design Engineer Product Development Engineer Regulatory/Compliance Professional Design Controls Engineer Six Sigma Green Belt Six Sigma Black Belt Continuous Improvement Manager Day 1 Schedule Lecture 1: Basic Statistics sample versus population descriptive statistics describing a distribution of values Lecture 2: Intervals confidence intervals prediction intervals tolerance intervals Lecture 3: Hypothesis Testing introducing hypothesis testing performing means tests performing normality tests and making non-normal data normal Lecture 4: ANOVA defining analysis of variance and other terminology discussing assumptions and interpretation inte
  • Start:December 07, 2017 Time: 9:00 AM
  • End:December 07, 2017 Time: 11:59 PM
  • Recurring
  • Where:Embassy Suites by Hilton Boston at Logan Airport, 207 Porter Street, Boston, Massachusetts, United States, 02128
  • Phone:N/A
  • Event Type: Business
  • Ticket Price:N/A
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