With Deborah A. Miller - Live Streamed Classroom - Register Now!
Next Course Date
October 28 - 31, 2024 Live Stream Classroom
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| Deborah A. Miller, MS, is a Principal Consultant for Windshire. She holds a Master of Science, Laboratory Medicine from the University of Washington. Her background includes extensive experience in GMP, CLIA, ISO, Deviations/CAPA, Interdisciplinary Communications, Complaints, Quality Management System Development, Change Control, Quality Assurance Management, and Compliance Auditing. Prior to joining Windshire Group, Ms. Miller was Director of Quality Assurance & Compliance, Diagnostic Manufacturing Division, American Red Cross and Special Assistant to the US Army Surgeon General Deputy Corps Chief for Laboratory Medicine. |
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Course runs 7:00 to 12:00 ET / 12:00 to 17:00 CET This course will provide participants with a comprehensive understanding of the terminology, regulations and mandated practices for conducting a study in compliance with GLP regulations. Those attending will get a thorough briefing of the relevance of accurate documentation, calibration and maintenance of instruments, and validation of relevant methodologies. |
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By the end of this three-day course, attendees will have a strong understanding of the fundamental compliance requirements for Good Laboratory Practices. While the focus of this course is the US FDA GLP regulation, Title 21, Code of Federal Regulations Part 58, other standards such as the US EPA GLPs, OECD GLP principles, and other international regulations will also be presented as a comparison. All participants will gain a fundamental understanding of the basis of the regulations and the necessity of rigorous implementation. Special attention will be given to incorporating proactive thinking and a robust compliance regimen in all scientific matters. The consequences of non-compliance will be examined, including a thorough review of examples of previous FDA inspectional findings. |
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