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CAPA programs for clinical research not required by FDA rules, but essential to correct problems.(Corrective/preventive action)
WASHINGTON -- Although corrective and preventive action (CAPA) programs for clinical research are not required by agency regulations, FDA refers to them in guidance and does expect you to correct problems that occur in your research, an Omnicare Clinical Research senior official said here. Also, because CAPA is only a guideline in clinical research, in litigation the court cannot say the lack of such a program caused a deficiency. However, if you have a good CAPA program, "it provides defense for your firm that indicates you are trying to solve problems."
Speaking at the recent DIA meeting, Bruce Wagman, vice president, U.S. regulatory affairs and global quality …
