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Monday, November 05, 2018
10:00 AM - 11:30 AM
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Overview: Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation
How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates
Why should you Attend:
In the medical device industry acceptance sampling plans are required for Validation/Verification/Effectiveness studies that must:
Be based on a written procedure
Aligns the plans to risk
Provides a valid statistical rationale
Areas Covered in the Session:
Claims that can be made when passing a sampling plan
How to select a sampling plan to make a specific claim
Different types of sampling plans including single, double and variables
How to reduce the number of units tested
Who Will Benefit:
Process Engineers and Management
Design Engineer and Management
Regulatory and CAPA Personnel
Statisticians
Speaker Profile:
Wayne Taylor is a leading expert on the application of Statistics to the Medical Device and other FDA regulated industries. His new book Statistical Procedure for the Medical Device Industry sets the standard for applying statistics in compliance with Section §820.250, Statistical Techniques of the Code of Federal Regulations.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates
Why should you Attend:
In the medical device industry acceptance sampling plans are required for Validation/Verification/Effectiveness studies that must:
Be based on a written procedure
Aligns the plans to risk
Provides a valid statistical rationale
Areas Covered in the Session:
Claims that can be made when passing a sampling plan
How to select a sampling plan to make a specific claim
Different types of sampling plans including single, double and variables
How to reduce the number of units tested
Who Will Benefit:
Process Engineers and Management
Design Engineer and Management
Regulatory and CAPA Personnel
Statisticians
Speaker Profile:
Wayne Taylor is a leading expert on the application of Statistics to the Medical Device and other FDA regulated industries. His new book Statistical Procedure for the Medical Device Industry sets the standard for applying statistics in compliance with Section §820.250, Statistical Techniques of the Code of Federal Regulations.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]