Statistics
Statistical tools are crucial in the management of process data and in their translation into information useful to the decision-making process. Understanding and knowing how to use these tools is therefore of fundamental importance within the development, industrialization, scale-up and technology transfer phases, as well as all the steps of the pharmaceutical production process: from incoming control to release, from API preparation to finished product packaging, from validation criteria to maintenance and continuous improvement plans. Among the objectives of the PTM courses in the statistical area is to form a critical sense of the use of the most common tools through dedicated workshops and application examples.
For more information about our training write to academy@ptm-consulting.it.
Courses Available ON DEMAND:
Duration: 4 hours
Contents:
• Brief introduction to 6-sigma
• Concepts of mean, fashion, median, variance and standard deviation
• Distributions
• Graphs (histograms, box plots, etc.)
• Confidence intervals
• Hypothesis test
Duration: 4 hours
Contents:
• Introduction to uni variate linear regression
• Output and model indicators
• Confidence intervals and prediction
• Introduction to multiple linear regression and nonlinear regression
• One and Two Way Variance Analysis (ANOVA)
Duration: 4 hours / 8 hours
Contents:
• Advantages of the factor approach
• Steps to follow for proper design of an experiment
• Complete and fractional design, resolution, aliasing, replication, randomization and blocks
• Tools for analysing an experiment: Pareto diagram, main effects diagram, interaction diagram, p-value and other regression model adequacy indicators
• Case study/Workshop
Duration: 4 hours
Contents:
• Central Composote Designs
• Box-Behnken Designs
• Computer-Generated Designs
• Analysis of a Response Surface Design
• Case study/Workshop
Duration: 4 hours
Contents:
• Introduction to Mixture Designs
• Test plan for mixture components only
• Test plan with process parameters
• Test plan with constraints
• Analysis of results: canonical form
• Model analysis: ANOVA, PRESS, Residues
• Analysis of the response surface
• Case study/Workshop
Duration: 4 hours
Contents:
• Analytical Quality by Design (AQbD)
• Regulatory landscapes
• Analytical Target Profile (ATP)
• DoE and AQbD
• Measurement System Analysis (MSA)
• Case study/Workshop
Duration: 4 hours
Contents:
• Terminology and definition
• Separate approach to accuracy and accuracy validation
• Combined approach to accuracy and accuracy validation
• Approach to LOD and LOQ validation
• Case study/Workshop
Duration: 4 hours
Contents:
• Introduction to control cards: what they are, why do it, what they evaluate
• The main types of control cards: for Variables and for Attributes
• CUSUM control cards
• Interpretation and evaluation of control cards
• Process capability: theory and application
• Case study/Workshop
Duration: 8 hours
Contents:
• Statistics for sampling plans
• ISO 2859 - Sampling plans for attributes
Duration: 4 hours
Contents:
• Introduction to Multivariate Statistics
• Factorial Analysis
• Principal Component Analysis
• Partial Least Squares
• Cluster Analysis
• Discriminant Analysis
• Logistic regression