Special Edition

Change Control Implementation

Change Control can be one of the most stressful and complicated procedures. This special edition seeks to shed light on the many different facets and applications of change control, including validation, training, management, medical devices, process validation, computer and software validation, regulations, and design.

Validation and Change Control
Gamal Amer, Ph.D.

The Training Side of Change Control
David E. Jones, M.S., R.Ph.

Considerations in Effectively Managing Change Control Issues
David M. Stephon

Characterizing Design Changes Throughout the Product Lifecycle
Rebecca Fuller Hyde

The Management of Change Control or Some Facsimile Thereof
John Stromp

Change Control FD-483 Citations – What Went Wrong?
Julie A. Thomas

Change Control: Seven Pharmaceutical Manufacturers Share Their Experiences
Nellie Waterland, Matthew Shapiro, Charles Douty, ArDen Grice-DuBose, Sophia McKinley, Gerri Thrasher and Marissa Ulmer

Implementing a Medical Device Change Control Program for Computer Validation Documentation
George Brower

Designing the Perfect Change Control System
David M. Stephon

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