Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report.

When there is a need to make some change to an environment and/or resolve a problem, we must think about a project that could implement the necessary change and address the problem. But we can’t just run our project without proper justification. Justifying the project is a great mechanism to confirm that our project really addresses the need and paves the way for improvement. It helps us assure interested parties or stakeholders that the project implements a particular solution to the problem and explains why this solution is best, as compared to other alternative solutions.

This 90-minute accredited course will help you understand and develop appropriate justification for implementing changes.

THIS TRAINING IS PART OF OUR FDA READINESS PROFESSIONAL CERTIFICATION

• To enroll into the complete FDA Readiness Professional Certification Program CLICK HERE. This program includes 10 specific online courses for $2050.
• To learn more about our certification programs, visit our website at Certifications

To register for this individual course ONLY, click the Register Now button below.