Expertise & Capabilities
Adsurgo is a professional services company solving problems through direct engagement consulting services and training workshops focused on the use of analytics.
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ASCEND WITH ANALYTICS
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ANALYTICS COURSES
Now Registering
Event | Date | Description | |
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Medtronic #3 |
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Applied Statistics for Scientists (2.0 days) |
| Applied Statistics for Scientists (2.0 days): This course provides instruction on how to apply scientific approaches to data analysis by focusing on appropriate methods for analysis: descriptive statistics, hypothesis testing, analysis of variance and model building. Applied Statistics for Scientists Objectives:
Outline: 1. Descriptive Statistics 2. Intervals 3. Hypothesis Testing 4. ANOVA 5. Simple Linear Regression 6. Model Building 7. Model Diagnostics |
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Quality by Design (QbD) using DOE (3.0 days) |
| Quality by Design (QbD) using DOE (3.0 days): This course focuses on This course focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance Quality by Design (QbD) using DOE Objectives:
Outline 1. Introduction to Quality by Design (QbD) 2. Primer on Statistical Analysis 3. Foundational Requirements for QbD Studies 4. Introduction to Design of Experiments (DOE) 5. Screening Designs – Identifying Critical Process Parameters 6. Response Surface Designs – Develop Functional Relationships and Establish Design Space 7. Specialized Designs 8. Utilizing Systematic Understanding from QbD Studies 9. Advanced DOE Methodologies (Self Study) |
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Reliability Engineering and Survival Analysis (1.0 days) |
| Statistical Methods for Reliability Engineering and Survival Analyses: This course covers the graphical and quantitative methods used reliability and survival analysis using JMP software. We will explore statistical methods to characterize and predict reliability and probability of survival. Topics include censoring, probability distributions—particularly Weibull and Lognormal, sample size determination, degradation/stability analysis, reliability with covariates/predictor variables, survival analysis, and fitting parametric survival models. Statistical Methods for Reliability Engineering and Survival Analyses Objectives:
1. Introduction to Reliability Methods 2. Reliability and Survivability Models 3. Advanced Approaches |
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Statistics for FDA Process Validation (3.0 days): |
| Statistics for FDA Process Validation (3.0 days): This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process development and validation program consistent with the FDA guidance. This course teaches the application of statistics for setting specifications and assessing measurement systems (assays), using design of experiments (DOE) for process design, establishing a strategy for process qualification, and ensuring process control/capability. All concepts are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents. Statistics for FDA Process Validation Objectives:
Stage 1 – Process Design Stage 2 – Process Qualification Stage 3 – Continued Process Verification Outline: 2. Primer on Statistical Analysis 3. Foundational Requirements for Process Validation 4. Stage 1 – Process Design 5. Stage 2 – Process Qualification 6. Stage 3 – Continued Process Verification 7. Advanced Methodologies (Optional) Appendix A – Capstone Exercise |
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Design of Experiments (DOE) using JMP (1.0 days) |
| DOE using JMP (1.0 days): This course focuses on how to establish a systematic approach to pharmaceutical development using design of experiments (DOE). All concepts are taught within the product quality system framework. Design of Experiments (DOE) using JMP:
Outline:
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Advanced Design of Experiments (1.0) Days |
| JMP Advanced DOE (1.0 days): This course builds on the DOE Using JMP material by providing more insight into the metrics of good designs such as prediction variance, power analysis, design optimality, and correlation between factors. We build on custom designs with constrained design regions/disallowed combinations and augmenting existing designs with new runs. We introduce new classes of designs useful in many practical applications: split plot designs (hard-to-change factors), space filling designs, mixture designs, and supersaturated (more factors than runs) designs. JMP Advanced DOE Objectives:
Outline:
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Statistical Tools for Process Control and Capability Analysis (0.5 days) |
| Statistical Tools for Process Control and Capability Analysis (0.5 days):
This course provides instruction on how to apply statistical tools to ensure your process operates in a state of (statistical) control. Although multiple tools are demonstrated, the course focuses on specific tools associated with SPC and process capability. All concepts are taught within the quality system framework. Statistical Tools for Process Control and Capability Analysis Objectives:
Outline: 1. Primer on Statistical Analysis for Process Control and Capability 2. Statistical Process Control and Capability |
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Adsurgo LLC
San Antonio, TX 78232