Learn about different statistical sampling strategies and the risk management strategies while auditing.

1. The Odds are Against Auditing: Statistical Sampling in Audit
December 14, Tuesday 10:00 AM PST | 01:00 PM EST
Why Should You Attend:
Sampling plans are paradoxical by their nature:
• If a system is out of control, a small sample will identify it.
• If a system is in control, even a large sample might not lead to any findings.
• Ineffective sampling plans can masks the ability to determine the correct state of the system being audited.
The purpose of auditing is to identify failures in the system or gross negligence. The real question, “how bad does the
system need to be for auditing to work?” This talk will look at statistical distribution for rare events to show that the
sample size needs to larger when the systems are better. This is a paradox for most auditors who when a problem is
discovered increase their sample size.
Most auditing sampling plans are based on either the binomial or normal distribution, though rare events usually follow
the Poisson distribution. This talk will show how the Poisson relates to the binomial and normal distributions. Special
attention will be given to risk management strategies. A review and comparison of different sampling strategies will be
presented.
Date: December 14, Tuesday 2010
Time: 10:00 AM PST | 01:00 PM EST
Duration: 90 Min
Instructor: Steven Walfish
Location: Your office or conference room (no need to travel!) Steven Walfish
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Areas Covered in the Seminar:
• Common sampling strategies.
• Risk based selection of sample size.
• Binomial distribution.
• Poisson distribution.
• Confidence intervals around estimates.
• How to justify a sampling plan.
• When is auditing not necessary.

2. Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including
companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit
include:
• QA managers and personnel
• Consultants
• Quality system auditors
Instructor Profile:
Steven Walfish, is the President of Statistical Outsourcing Services, a consulting company that provides
statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services,
Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD.
Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the
pharmaceutical industry. Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics.
Registration Information:
* Register Online. Use your American Express, Visa or MasterCard.
* For more than one attendee get 20% off on the price of additional attendee.
* Get your group to attend the webinar at a discounted price call +1- 650-620-3937.
* Call +1 - 650-620-3937 or Fax your PO: 650-963-2556.
* Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303.
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