The Consulting Service will provide a complete, individualized Validation Outline that includes testing protocols, acceptance criteria, reference materials, general discussion of technical issues, and hints and tips gleaned from our experience reviewing hundreds of validation studies. The consultants strive to clearly define the performance claims that Sponsors seek to validate. This service eliminates the guesswork and allows you to quickly organize your study and collect exactly the data needed to validate you method(s).

Validation Outlines can be created for any of the three AOAC Method Validation Programs.

Each Validation Outline consists of:
(1) Overview of validation requirements specific to each analytical test kit.
(2) Specific validation protocols.
(3) Discussion of testing procedures and acceptance criteria for all validation parameters.
(4) Discussion of areas for potential difficulties.
(5) Reference documentation, such as, Reference Methods.
(6) Recommended factors for Ruggedness testing.
(7) Proposed independent testing by AOAC Research Institute.

Validation Outlines requires approximately 2 weeks to develop and the cost includes a one-on-one meeting with the AOAC- RI Staff to examine the outline. Travel expenses are waived if the meeting is held at the AOAC- RI Headquarters or within a 300 mile travel perimeter of Gaithersburg, Maryland, U.S.A.

Sponsors must submit an application and sign a service agreement. The agreement specifies the product to be delivered, delivery time, etc. AOAC- RI staff will sign a confidentiality agreement if requested.

Consulting application cost: $3,000 per kit for Non-Contributing Members; $2,000 per kit for Contributing Members. A $500 discount will be applied to the PTM application when consulting services are requested.

I highly recommend the Consulting Program – we have had many companies tell us that it saved them a half a year in time and thousands of dollars using this process.

For more information regarding our services, about Contributing Membership benefits, or if I can be of further assistance for other matters regarding the AOAC Research Institute, please contact us at www.aoac.org.

Best regards,