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PDA Training and Research Institute (TRI)
Courses in Israel
The Israel Chapter of PDA is proud to offer
a unique opportunity of a two-day tailored course
Applied Statistics in Process Validation
and Ongoing Product /
Process Performance Monitoring
by Mr. Jason Orloff
Location: Kfar Hamaccabiah, Ramat Gan
SKU: 11711P
- Rare events and coincidences examined
- Definitions and rules of probability
- Statistical thinking and variability reduction
- Extreme values vs. outliers
- Histograms, dot plots and stem and leaf plots
- Process mapping and flowcharts
- Distribution analysis
- Trending and trend analysis (Create and Use Control Charts)
- Engineering control vs. statistical control
- Pareto charts
- Process Capability Analysis, Cpk
- Statistical Tolerance Limits for setting specification criteria
- Recognize good data collection
- Use graphical tools for analysis of data
- Calculate summary statistics
- Understand what “Six Sigma” is in statistical terms
- Understand confidence intervals and tolerance intervals
The workshop will include multi-media presentations and hands-on exercises
About the lecturer:
The lecturer, Mr Jason J. Orloff, is a consultant and trainer specializing in the application of statistics to quality, regulatory science and engineering for FDA regulated industry. In addition to on-site training at manufacturing plants, Mr. Orloff has also been invited to train at the PDA annual meeting and speak at the FDA. Mr. Orloff brings strong statistical, written, verbal, and project management skills and is a Chemical Engineer with real-life expertise at applying statistics in a regulated environment. As a partner with Lynn Torbeck at PharmStat, they share over forty years of experience in the application of statistics to Pharmaceutical Manufacture and Compliance.
Target Audience:
The class is intended to fulfill the training requirements of basic statistics for the 2011 Process Validation Guidance. Recommended participants would come from: Research and Development, Production Supervisors and Managers, anyone involved in Process Validation or Ongoing Product Performance Monitoring, anyone involved in developing analytical methods, QC supervisors, team leaders and second signatures as well as managers and directors, Preparers of Product Annual Review and of course Quality Assurance, Quality Systems Managers and Quality Assurance Personnel. Also personnel who will be required to analyze data applying statistical concepts or prepare or interpret control charts for online Statistical Process Control.
Please note: We already have "pre-bookings" for this course and attendance is limited. Since we anticipate a large demand please register early to reserve a place and avoid disappointment
 Participation Fee:
PDA member: 3200 NIS
Non-member: 4200 NIS
(includes PDA membership for one year)
For registration form please click here
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