If you are involved in the development or manufacturing of a medical product, sooner or later, you will face a regulatory inspection. The individual regulatory agencies publish many of their inspection procedures online, and these documents are valuable references for inspection readiness. The FDA has a manual for investigation operations and reference guides covering a variety of specific topics for drugs and devices. The EMA has a Joint Audit Program for GMP inspections and publishes a Compliance website describing their procedures at different phases. The agencies of other countries (Health Canada, for example) publish guidance and procedures as well. Use these references in your inspection preparation, self-audit, and quality enhancement activities to improve the quality of your products and work towards better patient outcomes.
Reach out to me if you want to know more or discuss your medical product development challenges.
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