Join Kay Monroe February 27 - 29 in our Live Streamed Classroom - Register Now!
All training until further notice will be offered by via live stream only. You will receive further information and instructions once you have registered. The Online Training will be delivered by way of Live interactive seminars. |
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| Next Course Date
February 27 - February 29, 2024 Live Streamed Classroom |
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| Kay Monroe is an industry consultant working for her own firm, Cayman Scientific Consulting, LLC, now based in Connecticut. She has extensive experience in R&D across multiple therapeutic areas and specializes in Project Management roles. |
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Course runs 12:00 - 5:00 ET / 9:00 - 2:00 PT This 15 hour course presents a comprehensive overview of process writing that the binding regulations require. There's a tenet among regulatory bodies: "If you didn't write it down, it didn't happen," and while the regulations tell companies what they need to do and document, they don't tell them how. Determining how systems work and how processes occur and documenting them is up to companies to assess. |
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Upon completion of this course, participants will be able to understand and describe the following: Understand the mandates for clearly delineated processes set forth by the Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Occupational Safety and Health Administration (OSHA), the International Organization for Standardization (ISO), and other governing bodies Have increased understanding of the role of written procedures in maintaining effective and compliant business activities Understand the importance of document integrity and established controls |
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