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.
