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K111
Creating a Pharmaceutical Installation Qualification

William N. Weaver , P.E.

This course consists of the information needed to create an Installation Qualification in compliance with FDA and GMP guidelines. In addition the student will find information on the relationship between the major Protocols (Qualifications) used in pharmaceutical validation.

The Installation Qualification is generally the first of a series of protocols required to validate a pharmaceutical machine or system. Creation of this protocol develops the foundation for the validation efforts to follow.

Information is included on equipment components, documentation, instruments and utilities and how each is to be validated during the execution of the protocol. The student is also provided with guidance for the execution of protocols.

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.

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