Introduction to Statistical Analysis of Laboratory Data
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Course Fee
$2150.00 Regular Registration
$1950.00 Early Bird Pricing (Register 30 Days in Advance)
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Course Description
Basic Methods: This section of the course will detail the basic and intermediate statistical concepts that are essential for professionals in the field. The first day emphasizes the principles of descriptive and inferential statistical applications and focuses on actual study examples, problem solving and interpretation of results. Throughout the course the participants are encouraged to ask questions and discuss examples relevant to their own work. Topic areas to be discussed include, but are not limited to:
- Basic statistical terminology including simple statistics as well as geometric ( e.g. means, standard deviations) transformations needed to effectively communicate and understand your data results
- The statistical testing (one sided, two sided, non parametric, sample size, and power considerations) essentials required to initiate a research investigation (i.e., research questions in statistical terms)
- Concepts of accuracy and precision in measurement analysis to ensure appropriate conclusions in experimental results including between and within laboratory variation results
- Discussion of statistical techniques to compare experimental approaches with respect to specificity, sensitivity and linearity
- The instructor gives a detailed description of topics discussed in the his latest publication, "Introduction to Statistical Analysis of Laboratory Data" by Alfred A. Bartolucci, Karan Singh and Sejong Bae (2015).
Advanced Topics: This section of the course will go beyond the basics and cover more complex issues in laboratory investigations with examples. Topics will include:
- Association studies including correlation and regression analysis with laboratory applications
- Analysis of robustness and ruggedness
- Method comparison using more accurate alternatives to correlate analysis and other pair-wise comparisons
- Outliers, limit of detection and limit of quantitation
Who Should Attend
This 15 hour course is designed as an introduction to the statistical principles of laboratory data analysis and quality control that form the basis for the design and analysis of laboratory investigations. The course curriculum will benefit R&D managers, analytical laboratory supervisors and staff, manufacturing and production professionals, scientists, technicians and others who wish to comprehend and interpret methods of data analysis relevant to laboratory experimentation. Where applicable, topics are presented with relevant regulatory requirements.
This training will concentrate on the philosophy and understanding of the statistical principles required in conducting sound scientific investigations of laboratory processes and validation, including design and sample size issues. It will not simply present statistical formulae and the lectures are oriented toward professionals having minimal formal training in statistics or mathematics beyond basic algebra. However, for those with more formal training in statistics wishing to actually apply the techniques, appropriate time and references will be given for the procedures involved.
Certification Tracks
- (BDCP) Biopharmaceutical Development Certified Professional™
- (CCCP) Clinical Compliance Certified Professional™
- (CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional™
- (CMDCP) Certified Medical Device Compliance Professional™
- (CMWP) Certified Medical Writing Professional™
- (CPVP) Certified Process Validation Professional™
- (GLPCP) Good Laboratory Practices (GLP) Certified Compliance Professional™
- (GRACP) Global Regulatory Affairs Compliance Professional™
- (PDCP) Pharmaceutical Development Certified Professional™
- (QSRCP) Quality System Regulation (QSR) Certified Compliance Professional™
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.