Price
Number
Learning Units (Hours)
Course
Quiz
William N. Weaver , P.E.
This two-hour course provides a basic understanding of the validation process as required by the Food and Drug Administration of the United States for drugs manufactured in the United States and all imported drugs. A few applicable definitions are included as are descriptions of the process and documents required in the validation of a facility. The process of validation is explained along with the intent of the validation effort. Relationships between types of protocols and other documents which occur at the same time during the construction and startup of a pharmaceutical facility are explored. The final results of the validation process are described and how the effort is prepared for an FDA inspection is touched on.
This course includes a multiple-choice quiz at the end, which is designed to enhance the understanding of the course materials.
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.