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RoseTECH Consulting, Inc. |
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Professionals Who Understand the Science Behind the Quality Assurance |
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Workshop Agenda & Location Details Click here to register |
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Workshops begin at 8:15 a.m. and end ~4:00 p.m. GLP Training Workshop - Tuesday March 18, 2008 This one-day workshop is designed to provide a thorough understanding of the FDA, EPA and OECD GLP requirements and responsibilities involved in the conduct of GLP studies. The GLP Regulations (21CFR Part 58, 40 CFR Part 140 and 792) as well as OECD GLP Principles will be covered. Participants will become familiar with the GLP regulations and principles to better understand why GLP requirements are so important and as well as to know “where it is written”. “Real-life” examples and scenarios will be used to convey key points. The workshop will stress study compliance and the importance of record-keeping, good documentation practices, and study reconstructability. This course would benefit persons new to the GLP environment as well as in in-depth refresher for those experienced in the conduct of GLP studies. · GLP Overviews and Highlights This session provides an in-depth overview of the GLP regulations FDA 21 CFR Part 58, · GLP Roles and Responsibilities This session details the responsibilities of study personnel; individuals involved in the conduct of GLP studies. Roles and responsibilities of Study Director, Test Facility Management, Test Site Management, QA, as well as support activities such as Archivist are also briefly covered. Emphasis is on responsibilities for the day-to-day conduct of studies. · Record-keeping and Documentation Practices Accurate, complete record-keeping and good documentation practices are critical to the integrity of a GLP study. This session covers all recordkeeping requirements stipulated by the GLPs as well as best practices for good documentation. “Real-Life” examples poor documentation practices are presented to reinforce the importance of good documentation practices and to help the participant apply the information to daily operations. The reasons why good documentation practices are important are also conveyed. · Study Reconstructibility Integrity of a GLP study depends on study reconstructibility. Study reconstructibility from protocol to final report including all documentation in between (raw data, deviations, etc) is presented . Practices which contribute to the reconstructibility of a study are demonstrated. Location of workshop: Corporate College East 4400 Richmond Rd, Warrensville Heights Ohio 44128. CCE is located approximately 26 min from Cleveland Hopkins Airport. Nearby Accommodations Marriott Hotel (0.5 mi from Workshop location) 26300 Harvard Rd Warrensville Hts, Oh 44128 Phone: 216-378-9191 Residence Inn & Suites 3628 Park East Drive Beachwood, Oh 44122 Courtyard by Marriott For information on ground transportation, |
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