|
R |
|
RoseTECH Consulting, Inc. |
|
Professionals Who Understand the Science Behind the Quality Assurance |
|
Workshop Agenda & Location Details Click here to register |
|
Workshops begin at 8:15 a.m. and end ~4:00 p.m. Study Director Training Workshop - Wednesday March 19, 2008 This one-day workshop is designed to provide the participant with a thorough understanding of the GLP requirements and responsibilities of the Study Director role, as well as soft skills and writing skills which are key for effective quality study conduct. As the “single point of study control”, the Study Director role is a critical role in the conduct of GLP studies. The session will cover study compliance and the importance of good documentation, effective writing, and study reconstructability. This workshop will benefit persons currently serving in the role as Study Director and those who may advance to role of Study Director. This course also in beneficial to Managers and QA professionals who would like to get a better understanding and appreciation of the role and responsibilities of the Study Director. This session has been presented several times by Celeste Rose at the Society of Quality Assurance annual conference training workshops. Attendees have found this workshop to be extremely beneficial. · GLP Overviews and Highlights - FDA, EPA, OECD This session provides an in-depth overview of the GLP regulations FDA 21 CFR Part 58, · GLP Roles and Responsibilities of Study Directors This session keys in on the regulatory role and responsibilities of the Study Director and is not limited to those described in 21 CFR Part 58.33, 40 CFR Part 160.33 or 792.33. It covers all aspects of the study director role as required through the entire GLP regulations. · Building Effective Study Director Skills In addition to technical and regulatory qualifications, several other skills are important for effective study direction. This session will cover skills such as organization, leadership, delegation, effective communication, etc which are key to the success and quality of a GLP study. · Quality Documentation and Study Reconstructibility Reconstructible documentation is imperative to the quality and compliance of a GLP study. This section will cover quality documentation including protocols, amendments, deviations, raw data and study documentation, and final reports. Clear, concise writing is a key to study reconstructibility. This section will cover effective documentation, report writing, with a focus on writing for the “reader”. This will include technical writing helpful hints and report organization skills to produce well-written documents. 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, |
|
R |