With Julie Barnhill, Ph.D. October 1 - 2 in our Live Streamed Classroom - Register Now!
Next Course Date
October 1 -2, 2024 Live Streamed Classroom |
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| Julie Barnhill, Ph.D. is a Consultant with Meridian BioGroup LLC and provides QA Compliance expertise to Biopharma/Pharmaceutical companies with products in preclinical, clinical and commercial stages of drug development with the primary objective of helping clients advance their drugs through pipelines and regulatory processes. |
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Course runs 7:00 to 12:00 ET / 13:00 to 18:00 CET This course will provide an in-depth understanding of how to meet FDA expectations regarding equipment validation and qualification in the analytical laboratory. Requirement from several sources (USP, PhEur, and JP) will be referenced and the similarities and differences will discussed. It also will discuss in detail the necessary time, applicability, and activities associated with analytical instrument qualification through the whole system lifecycle – from design, installation, operation and performance qualifications to PM and removal from service. |
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Upon completion of this course you will have a thorough knowledge and understanding of FDA expectations regarding the validation and qualification of laboratory equipment and the know-how necessary to plan and execute effective and compliant lab equipment qualification (EQ) programs. You will also understand why laboratory equipment validation and qualification are significant as a foundational step for overall system sustainability, and why EQ is the necessary first step when initiating validation of analytical methods. |
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