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Software Validation April 27 - 29

SOFTWARE VALIDATION REQUIREMENTS

This course outlines the general principles on software validation. This includes guidelines on medical device software and software used to develop and manufacture products regulated by the Food and Drug Administration (FDA).

This course is designed for Software Quality, QA/QC, Engineering, Manufacturing, and other personnel as desired. Training to be covered by industry leaders.

Emphasis on the following:


 Scope of FDA regulation on software

 Software Validation Requirements

 Verification Vs Validation

 Software Quality Planning

 Quality Review

 IQ/OQ/PQ Overview

 Design Changes and Revalidation

 Electronic Records and Signatures


Date: April 27 - 29, 2009; Time: 8 am to 4:30 pm daily. Full agenda and packets available on arrival.

Registration ends April 17th. For registration after April 17, please call 847-677-0021 to verify seat availability.

Refund Policy: 100% credit towards future registration if cancelled by April 10th, 2009; or you may substitute co-employee by April 17th, 2009.

Location: Global PharmaDevice Solutions, Main Auditorium, Illinois Science and Technology Park, 8045 Lamon Ave. Skokie, IL 60077

Registration Fees: $1010; 5% discount for two or more registrants from same company, or 10% discount for IL Science and Technology Park employees (A registrant cannot use both discounts).

Meal: Continental breakfast, and lunch will be provided on both days.

Hotel Information
Holiday Inn - To obtain discount for your accommodation during this training, refer to code #200901 during your reservation. Shuttle bus is provided at no additional cost. Distance to the training center is 1.8 miles.

Doubletree Hotel - To obtain discount for your accommodation during this training, refer to code #200901 during your reservation. Shuttle bus is provided at no additional cost. Distance to the training center is 1.6 miles.

Certificate: Upon successful completion of the test given at the end of training, a certificate of understanding of Software Validation Requirements will be issued.