Statistical
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4-Hour Virtual Seminar on Design and Conduct of Clinical Trials – Design Requirements, Statistical Issues, and Clinical Protocols
Clinical trials play a pivotal role in evidence-based medicine. This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical research. Topics will include basic principles and current methodologies used in the design, implementation, and... -
4-Hour Virtual Seminar on Statistical Process Control
Statistical process control (SPC) is a form of feedback process control that does for discrete products what automatic process control does for the chemical process industry. Its purpose is to distinguish special or assignable causes from random or common... -
5S Workplaces – When Lean and Safety Meet
5S, which refers to the five Japanese words for clearing up, arrangement, neatness, discipline, and ongoing improvement, is a workplace organization system that also supports safety; the sixth S. It achieved proven results at the Ford Motor Company during... -
6-Hour Virtual Seminar on Adaptive Design for Clinical Trials
Duration: 6 Hours
Presenter: Elaine Eisenbeisz -
6-Hour Virtual Seminar on Biostatistics for the Non-Statistician
Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand... -
6-Hour Virtual Seminar on Statistics for Process Control
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical process control: obtaining monitoring... -
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
The seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and... -
CAPA and AIAG’s CQI-20 – Effective Problem Solving
Corrective and Preventive Action (CAPA) plays a central role in quality management systems. Its customer and supplier processes include far more than just control of nonconformances; they also include customer feedback, audit findings, the management review, and even more.... -
Design of Experiments for Non-Statisticians
The solution of many Pharma and Biotech problems include the collection, analysis, interpretation and presentation of data. The use of design of experiments in the form of two-level factorial and fractional-factorial designs increases the probability of finding an acceptable... -
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Improving Process Stability and Capability – Tips, Traps and Guidance
FDA’s Process Validation Guidance Stage 3 calls for “ongoing assurance is gained through routine production that the process remains in a state of control.” Two critical considerations in assessing process behavior are process stability and capability. Tools commonly used... -
Integrating Lean and Project Management
Whether you work on projects or improvement initiatives, you will benefit from this session that integrates the commonalities of Lean and Project Management. Both methodologies are focused on leading some type of change in your organization, from departmental to... -
Introduction to Design of Experiments
Design of Experiments (DOE) is an important technique for root cause analysis (RCA) and process improvement. As an example, when potential trouble sources are identified from a cause and effect diagram, DOE can be used to determine which of... -
Measurement Systems Analysis
Calibration (accuracy) has been traditionally required by ISO 9001, but measurement systems analysis (precision) has not – although it has been an element of the automotive standard IATF 16949 ever since the latter was QS 9000. Accuracy and precision... -
Measurement Uncertainty in Microbiology
This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples. Laboratories are often confused about... -
Method Validation – Utilizing Quality by Design (QbD) and Risk in Implementation
Pharmaceutical industry is experiencing a growing need to improve performance driven by global competition and the increasing impact of information technology. FDA’s Process Validation Guidance calls for continued process verification which applies to both manufacturing and measurement processes. How... -
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Metrology: Statistical Analysis of Measurement Uncertainty
The seminar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and “uncertainty ratios”. Several of the standard methods for analyzing measurement variation are then described and explained, as derived...