Pacific Rim Consulting, Inc. - NEWSLETTER
Volume 11 Issue 1 - Winter 2008
All courses are designed to be very interactive and present practical approaches to implementing the GLPs. Attendees are highly encouraged to participate in discussions and workshops. Problem solving and “what if” workshops are provided to promote discussion. Courses are structured around effective compliance implementation, stressing the use of GLPs to substantiate and increase data quality and integrity.
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Course Descriptions |
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GLPs for Study Directors and Monitors |
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GLPs 101 |
This one-day seminar will provide a brief overview of the Good Laboratory Practice Regulations, with emphasis on the most critical aspects, including study conduct, documentation, SOPs, equipment logs, test material and test system requirements, and personnel responsibilities. Specifically designed for anyone who wants a better understanding of the GLPs, this course would also benefit most attendees of the “GLPs for Study Directors and Monitors” course. It could also serve as excellent exposure to GLP principles for companies, individuals, or Universities contemplating entering the field of regulatory research. A training manual with essential background
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GLPs in the Real World |
Many companies (and people) go through the motions of trying to implement Good Laboratory Practices without really understanding their importance in generating high quality, reproducible studies and data. This two-day seminar will combine an overview of the Good Laboratory Practice Regulations with techniques for implementation of the most critical aspects of GLPs. Topics include study conduct, documentation, SOPs, equipment logs, test material and test system requirements, and personnel responsibilities. Specifically designed for anyone who wants a better understanding of the GLPs, or is implementing GLP systems within their facility, this course focuses not only on what GLPs require, but the underlying reasons for the various requirements of the regulations. It could also serve as excellent exposure to GLP principles for Companies, Individuals, or Universities contemplating entering the field of regulatory research and scientists and technical staff currently involved in GLPs. A training manual with essential background reading and reference material is provided.
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GLPs in the Bioanalytical Laboratory |
Applying GLP principles to the Bioanalytical portion of Clinical studies can result in high quality data when approached correctly. Many times companies require “GLP Compliance” for the bioanalytical analysis of a clinical study without fully understanding GLPs. In addition, many laboratories that provide bioanalytical services for both GLP and GCP studies struggle with interpreting the differences in the various regulations and guidance documents. This course explores a practical application of GLP principles to bioanalytical analyses (whether in support of clinical or GLP studies), including technical as well as regulatory compliance requirements. It is a valuable training for all scientists working in the FDA Bioanalytical environment. QA personnel could also benefit from attendance.Please note - this class will also investigate and evaluate different approaches for validation, partial validation, handling repeats and other technical issues that are faced in the regulatory bioanalytical environment. In order to explore and address the more technical and regulatory requirements of bioanalytical assays, an expert in this field will be co-instructing.
Dr. Chris Tudan, a regulatory Bioanalytical expert, will provide insight regarding technical requirements and industry standards for data quality. Chris has worked in a variety of Bioanalytical labs, developing and validating both ligand-binding and LC-MS/MS assays in the role of both sponsor and CRO. He is President of BioAccurate Enterprises, Inc., a consulting firm that provides technical and regulatory expertise to the regulatory community. Chris, trained as a drug discovery biochemist, has been involved in the development of many assays for discovery and characterization of both small and macromolecules (including peptide memetics), resulting in numerous patents, publications and clinical submissions. He has utilized LC and LC-MS/MS throughout his career, developing and validating bioanalytical methods, including GLP-compliant DDI methods, in GLP labs. Dr. Tudan has been called upon to stream-line sample preparation processes as a managing scientist and consultant for greater sample analysis efficiency and is well versed in strategies for successful development and validation of methods as measured by robustness, speed and compliance. Chris offers a unique ability to merge the regulations associated with BA in a GLP environment with the technical and specific method-related details.