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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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October 25, 2010 |
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GlobalCompliancePanel, USA
2010-11-16
Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.
Areas Covered in the Session: - How to collect a sample
- What are the two types of error (Type I and Type II)
- How to calculate sample sizes for variables data
- How to calculate sample sizes for attribute data
- Using confidence intervals on Cpk to calculate a sample size
- Using binomial confidence intervals
Who Will Benefit: - Management
- Research and Development
- Regulatory Affairs personnel
- Quality assurance/quality control personnel
- Auditors and inspectors
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Steven Walfish: - Mr. 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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Deadline for Abstracts:
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2010-12-09
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Registration:
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Tuesday, November 16, 2010
10:00 AM PDT | 01:00 PM EDT | | | Live live online training only for one participant | | |
| | | | | | Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) | | |
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E-mail:
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webinars@GlobalCompliancePanel.com
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