You need not be a professional statistician to correctly utilize statistics for routine pharmaceutical and medical device problems and activities in management, quality, manufacturing, stability and technical support departments.
Science graduates with the aid of explanatory statistics and sampling software can design experiments and interpret data. They can perform their jobs more effectively and reliably with confidence. Explanatory statistics software reports the applicable assumptions for each test and whether the data satisfy the assumptions.
Explanatory statistics software is organized and utilized by what the operating objective or problem is, for example, compare two groups of data, describe numeric data, or determine the process capability. The burden of deciding what statistical test should be performed is vastly diminished. When the problem is chosen from the menus, the software selects and performs the right combination of appropriate tests and plots. It reports the results and conclusions in readily understandable language with presentation quality graphics that facilitate understanding. Calculations and plots are automatically performed. No need to struggle with statistical calculations and analysis any longer!
The test results and explanatory text plus graphics output support qualification and validation studies, problem solving, deviation and investigational studies, sampling, trending, SPC/SQC and many other statistics based problems.
Learning Objectives:Understand the statistics methodologies associated with risk-based qualification of instruments and equipment, and validation of test methods and manufacturing processes.
Design studies and collect data in support of pharmaceutical laboratory and manufacturing operations.
Assess test methods, processes and materials for adequacy and conformance to requirements.
Establish acceptance criteria and sample sizes for validation and qualification studies.
Set raw material and finished product specifications.
Establish appropriate test method and manufacturing process characteristics.
Calculate, interpret and utilize confidence and tolerance intervals
Perform equality, equivalence, and inferiority and superiority studies.
Design sampling plans for experimental studies and incoming raw materials (acceptance sampling).
Design drug stability studies and establish drug expiration periods conforming to USP and FDA requirements.
Make valid comparisons and correct, risk based conformance decisions.
Assess linearity, accuracy, analytical and manufacturing process capability.
Prepare and interpret process behavior charts (SPC/SQC).
Identify controlled processes and predict future performance.
Identify normal and non-normal data – and work with each.
Communicate statistical analysis results, conclusions and claims.
DAY 01(8:30 AM - 4:30 PM)Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Introduction and review of basic concepts in statistics and the use of explanatory software
Problem and solution: how to characterize and understand sample data. Is there an outlier in the sample?
Problem and solution: how to compare groups of data
Problem and solution: how to assess linearity for calibration
Problem and solution: how to simultaneously determine linearity and accuracy of a system
Problem and solution: how to determine sample size for studies
DAY 02(8:30 AM - 4:30 PM)Problem and solution: how to determine sampling plans for accepting raw materials from a stream of incoming lots.
Problem and solution: how to determine sample size for a sample taken from an isolated collection or population.
Problem and solution: how to set a drug expiration date by USP and FDA criteria
Problem and solution: Is the process in control? Predictable? Produce a homogeneous product stream?
Problem and solution: Is this process/product capable of meeting its requirement?
Problem and solution: how to set a standard deviation target for a new method or process.
Problem and solution: how to set risk-based conformance decisions based on probable error. Does this product conform to its specification?
Problem and solution: how to set risk-based acceptance criteria based on probable error
Problem and solution: What is equivalence testing and when to use it? Demonstrate setting equivalence sample size and perform an equivalence test?
Demonstrate process simulation and its benefits