ComplianceOnline

The Odds are Against Auditing: Statistical Sampling in Audit

Instructor: Steven Walfish
Product ID: 701540
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jan-2012

Training CD

$499.00
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(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This webinar will cover different statistical sampling strategies and the risk management strategies while auditing.

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 60-minute training 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 presentation 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.

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.

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.

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.

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Validation, Verification and Transfer of Analytical Methods
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews Write review

Very informative and useful. Information I can actually use here at work, Thank You Mr. Walfish!
- Anonymous

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