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A Practical Approach to Pharmaceutical Commissioning and Qualification

Timothy D. Blackburn, MBA, PE

An initial response to the recommendation to do Pharmaceutical Commissioning is that it is just an additional step – another roadblock to engineering success and something repeated during Qualification. However, effective Commissioning supports engineering and Qualification success. This course addresses efficient Commissioning techniques and synergizing with Qualification. Examples presented are not all definitive, and documentation may exceed or not include certain elements – Commissioning (and Qualification) must be structured for the project. This course contains much of the material basic Commissioning course, but focuses on the Pharmaceutical industry and recent initiatives at Commissioning. The Author has been a leader in the Pharmaceutical industry in the application of documented Commissioning to minimize the regulated paperwork required for Validation/Qualification. He shares his learned experiences in this course in the practical application of commissioning as it specifically relates to Pharmaceutical projects. (Note: See the course entitled “Commissioning Fundamentals and a Practical Approach” for a cost efficient method to apply Commissioning also.)

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.