Seminar Schedule 2008-2009
Statistical Methods to Determine Sample Size
Cost $Free
San Jose
August 11, 2008
Instructor:
Steven Walfish, Founder and President of Statistical
Outsourcing Services a consulting company that provides statistical
analysis and training to variety of industries.
Mr. Walfish brings over 20 years of industrial expertise in the development
and application of statistical methods for solving complex business
issues including data collection, analysis and reporting. Mr. Walfish
has held positions with Johnson & Johnson and Chiron Diagnostics
where he worked with large data sets for monitoring process data.
Mr. Walfish holds a Bachelors of Arts in Statistics from the University
of Buffalo, Masters of Science in Statistics from Rutgers University
and an Executive MBA from Boston University.
Mr. Walfish has taught public courses on basic statistics, design
of experiments and regression analysis.
Agenda:
Introduction and Basic Overview of Statistics
- Types of data (discrete versus continuous)
- Summary statistics (mean, median, variance, CV)
- Basics of hypothesis testing (t-test and z-test)
Trending Analysis
- Plotting data over time
- Statistical limits for trending
- Control chart diagnostics
- Control limits versus confidence levels
Outlier Analysis
- Labeling outliers
- Box plots and other graphical techniques
- Trimmed Means
- Dixon and ESD
- Retest procedures
Sample Size Calculations
- Types of sampling plans
- Measurement error
- Power of a sample
- Sampling error
- Continuous sampling size calculation
- Attribute sampling
Overview:
The course will provide a one day overview
of basic statistical methods and sampling strategies. From basic statistics
to more advanced topics such as sampling and trending will be covered.
Networking with other professionals is an important part of any conference
and is encouraged at WESTPAK gatherings.
Medical Package Testing & Validation (One Day) MPT 165 Cost $495
San Diego
August 20, 2008
Who should attend?
QA Managers, Project Mangers and Assembly Technicians.
This course will focus on the development of a successful package
testing protocol based on the requirements for package testing outlined
in ANSI/AAMI/ISO 11607 with focus on Part 2 of this document. This
course is for professionals in established companies as well as start-ups.
The course will focus primarily on Protocol Development and laboratory
time will be dedicated to Sterile Integrity testing. At the completion
of this course you will have a better understanding of the packaging
requirements for sterile devices.
Instructor:
Mark Escobedo, Westpak, Inc.
Areas Covered:
Review of terminology
Dynamics overview
Distribution environment quantification
Temperature & humidity levels
Performance Tests ASTM D 4169, ISTA tests
Effect of Altitude
ANSI/AAMI/ISO 11607 Parts 1 and 2
TIR 22 Guidance Document
Determination of product vibration and shock sensitivity
Shock and Vibration
Heat-seal validation
Sterile Barrier Testing (Bubble ASTM F2096, Peel ASTM F88, Burst test
ASTM F1140)
Shelf-life Study (Real-time and Accelerated aging ASTM F1980)
Internal Company Protocol Development
Define parameters
Test documentation
Overview:
This seminar will focus on the development and execution of a test
validation plan. The seminar includes time for lab demonstrations
of the covered tests and Q&A. Networking with other professionals
is an important part of any conference and is encouraged at WESTPAK
gatherings.
Package Drop Testing
October 8, 2008
Who should attend?
Package Designers, Distributors, Project Managers,
Product Developers
This course is designed for those who possess a basic or introductory
knowledge in the area of drop testing and want to increase their understanding
of drop testing.
Instructor:
Mark Escobedo, WESTPAK, Inc.
Areas Covered:
Review of cushion dynamic testing
Specifications and procedures
Proper instrumentation
Drop height determination
Number and orientation of impacts
Use of the data collected
Waveform analysis
Drop test setup
Temperature & humidity effects
Overview:
Considerable time will be devoted to actually running the test procedures,
collecting data, and analyzing the results. This is a "hands-on"
seminar to help each attendee master the techniques of collecting
and analyzing drop test data. Networking with other professionals
is an important part of any conference and is encouraged at WESTPAK
seminars.
Package Vibration Testing (One Day) VPT 120 Cost $495
San Jose
Date: November 19, 2008
Who should attend?
Package Designers, Distributors, Project Managers,
Product Developers
This course is designed for those who possess a basic or introductory
knowledge in the area of vibration testing and want to increase their
understanding of vibration testing.
Instructor:
Mark Escobedo, WESTPAK, Inc.
Areas Covered:
Terminology Overview
SDOF Spring/Mass Modeling
The Concept of Resonance
Fatigue or Dwell Tests
Damping
Measuring the Distribution Environment
Vibration Sensitivity Using Sine
Vibration Sensitivity Using Random
Measuring Cushion Vibration Performance
Common Materials for Vibration Package Design
Package Testing and Design Modification Mechanical "Bounce"
Test
Specifications
Case Histories
Overview:
This seminar is a basic seminar covering the concepts of vibration
testing in detail. The seminar will focus on applications in a manner
that increases comprehension and reduces confusion. Lab demonstrations
and reference materials are included. Networking with other professionals
is an important part of any conference and is encouraged at WESTPAK
seminars
ISTA vs ASTM
Pitfalls and procedures
Overview :
This seminar will cover myths and mysteries of the ISTA 2 series, 3 series, and ASTM D4169 test protocols. This seminar is for people who are familiar with testing or are required to understand the package testing protocol. The seminar will cover similarities and differences between the two protocols and how to use them