Close Up Radio Spotlights Validation Consultant Connie Curts

Lee’s Summit, MO – Connie Curts is a validation consultant. She specializes in developing validation documentation for FDA-regulated equipment dedicated to pharmaceutical research.

“Everything that goes into a study to develop pharmaceuticals needs to be accurate, so all procedures must be followed specifically without deviation,” says Connie. “What I do is create the documents to define the intended usage for clients. There are user requirements against which you'd test the system to determine its accuracy. I create those test protocols, somebody else executes those protocols, and yet another person is reviewing the results to make sure the system demonstrates its performance.”

An IT professional by trade with a background in engineering, Connie develops the documentation for completeness and clarity, so clients know what they need to do to remain in compliance and everything is handled consistently and tracked through chain of custody.

“It's a tremendously complicated process, which is partly why drugs, especially new drugs, are so expensive,” says Connie. “With validation, you  have to be very careful because in the long run, as with everything in health care, a patient's life could be at stake.”

“I prefer to tinker with things, make them work, debug them,” says Connie. “I also love teaching and giving back to the next generation, everything I could about my experiences and best practices for good laboratory procedure.”

She was one of 95 international collaborators on the book entitled Computerized Systems Used in Nonclinical Safety Assessment:  Current Concepts in Validation and Compliance.