Statistical Tools for Pharmaceutical Quality Control

09:00 – 13:00 SESSION COURSE DAY 1
09:00 – 13:00 SESSION COURSE DAY 2

INTRODUCTION

• Descriptive Statistics vs. Inferential Statistics

STATISTICAL METHODOLOGIES

• Notions of Probability and probability function
• Main discrete (Binomial and Poisson) and continuous (Normal or Gaussian and Student’s t-distribution) probability functions with practical application examples
• The Normal distribution
• Concept of confidence interval and how it is calculated
• Hints at Prediction and Tolerance intervals
• Outliers: statistical tests to detect their presence (e.g., Grubbs, Dixon) and possible operational approaches (e.g., Winsorization, Trimming)
• Normality tests (Anderson-Darling, Kolmogorov-Smirnov, Shapiro-Wilk) and data transformation techniques

COMPARISON OF MULTIPLE SETS OF MEASUREMENTS

• Null and alternative assumptions: errors of species I and II
• Significance of difference between means: Student’s t-test (one-sided and two-sided test; dependent or independent samples); ANOVA test (fully randomized model: one-way, two-way)
• Significance of difference between variances: F-test, Bartlett’s test, Cochran’s test
• The alternative to significance tests: equivalence tests
• Components of variance for precision estimates

LINEAR REGRESSION

• Method of least squares
• Linearity tests (lack-of-fit, Mandel’s test)
• Analysis of residuals and influence of data (Bias and Leverage)
• Interpretation of ANOVA test on linear model
• t-test for intercept and slope
• Linear regression and comparison of calibration models (traditional tests vs. Akaike Information Criterion (AICc), TOST for bias)

Personnel involved in the pharmaceutical sector:

• Analytical Development
• Quality check
• Conformity and Quality Assurance
• Research and development
• Production
• Regulatory Affairs

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.