Software Validation

(Short-term career training: 80 lecture hours + 120 lab hours by arrangement)

This course is represented as preparing students to work as Software Validation Specialists (or equivalent job titles). The specialists in this field are responsible for validating changes in computer software used by companies compliant with FDA regulations.

The course covers numerous issues related to FDA regulations, GMP, and how to stay compliant with them. Major topics include the following:

An understanding of the regulatory requirements and expectations for validation of computer systems used in pharmaceutical / biotech manufacturing
History of FDA
Computer System Validation methodology
How to apply these concepts to systems within your own organization
The regulatory inspection process and how to be prepared

CURRENT SCHEDULE OF CHARGES

(Short-term career training: 80 lecture hours + 120 lab hours by arrangement) Registration fee: $75.00 (Mandatory, non-refundable)
Tuition: $1,925.00 (Mandatory, refundable. See Refund Policy)
Manuals, handouts, lab time and equipment: at no charge to students
Total: $2,000.00

The total amount for all fees, charges and services the student is obligated to pay for the course is $2,000.00 (two thousand dollars).

CANCELLATION AND WITHDRAWAL POLICIES

Refund Policy

Rules of Operation

Student Services