Validation Sampling Plans for Process Validation [Latest]

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Category Statistical Methods, Medical Devices, Sampling Plans 2018, importance of statistics, statistics example, scope of statistics, Warning letters, Process Engineers and Management, Destruction Test Methods

Deadline: November 04, 2018 | Date: November 05, 2018

Venue/Country: Online, U.S.A

Updated: 2018-09-07 15:27:19 (GMT+9)

Call For Papers - CFP

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

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Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

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