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What's New?

Guide to Acceptance Sampling - First Edition Available Electronically -  (Added 6/3/11)

The second edition is delayed until the end of the year.  In the interim, electronic copies of the first edition may be purchased.  A second edition is planned for Mid 2012.

32-bit versions of the programs can now be downloaded that run on both 32-bit and 64-bits versions of the Windows operating systems.

New FDA Guidance Document - Process Validation of Drug-  (Added 2/6/11)

Issued January 2011 - Food & Drug Administration (FDA): “Process Validation: General Principles and Practices,” January 2011.  Covered in the course Process Validation Principles.  

Process Validation Principles - New Course  -  (Added 2/16/08)

Primarily focused on medical devices, covers the FDA regulations and the Global Harmonization Task Force guidelines.

Pharmaceutical and Medical Device Validation by Experimental Design - New Book -  (Added 1/3/08) Dr. Taylor authored the chapter "The Role of Designed Experiments in Developing and Validating Control Plans" in the above book.

Distribution Analyzer Version 1.2 Released -  (Added 12/25/07)

Version 1.2 of Distribution Analyzer is now available for downloading.  This is a new package to aid in validation, verification and qualification studies.  It aids in the application of normal tolerance intervals and variables sampling plans by testing for normality, transforming the data if necessary and then calculating the confidence statements.  You can download the software and use it free of charge for 30-days.  Version 1.2 updates the help system to operate under Windows Vista and fixes several bugs causing error error messages to occur when clicking the Find Best Distribution button.

New Course Validation Sampling Plans -  (Added 4/5/06)

This course covers determining sample sizes and acceptance criteria for validation and other 1-time studies.  It can be offered at your location.

New Course Normality and Transformations -  (Added 4/5/06)

This course covers how to test for normality and handle nonnormal data including fitting other distributions and transforming data.  It can be offered at your location.

Book Optimization & Variation Reduction in Quality -  (Added 7/16/05)

The book Optimization & Variation Reduction in Quality is back in print, this time as soft cover book.