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Good Documentation Practices (GDP) For FDA Regulated Industries

Susan Marshall, P.E., MBA

This course provides information on Good Documentation Practices (GDP), which is a specific way of managing and correcting documents. Many documentation and library practices are used throughout the world; however, GDPs are different and much more comprehensive than any library or law office archives. GDPs go much further than organization or filing. GDPs require documents, both paper and electronic are always clear regarding who, what, when, and where the data/information was obtained.

Data retrieval and protection are critical aspects of GDPs. The information must be readily available in an unaltered state and protected from intentional and unintentional deletion and overwriting. Originals must be kept for specific amounts of time, in some cases for decades.

GDPs are important and required by the FDA because the documentation for regulated industries provides evidence the products/data were made/generated in accordance with regulatory requirements and internal specifications. Patient safety is the top priority and following GDPs is one of the foundations of proving the proper procedures and practices were followed at every step. Quality of products and data must be assured in order to protect patients.

Good Documentation Practices can benefit every industry and profession, especially engineering, where public safety is a #1 priority.

This course includes a multiple-choice quiz at the end, which is designed to enhance the understanding of the course materials.

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NY PE & PLS: You must choose courses that are technical in nature or related to matters of laws and ethics contributing to the health and welfare of the public. NY Board does not accept courses related to office management, risk management, leadership, marketing, accounting, financial planning, real estate, and basic CAD. Specific course topics that are on the borderline and are not acceptable by the NY Board have been noted under the course description on our website.