Pacific Rim Consulting, Inc. - NEWSLETTER
Volume 13 Issue 2 - Page 2 - Fall/Summer 2010
Course Descriptions |
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.
GLPs for
Study Directors and Monitors |
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 as well as scientists and technical staff currently involved in GLPs. A training manual with essential background reading and reference material is provided.
GLPs 101 – an Introduction |
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 reading and reference material is provided.
GLP TRIPLE PLAY - NEW!!!!! |
This is a three day intense training opportunity covering the hottest topics in regulatory research. Day 1 will focus on Current GLP issues, Day 2 on Validation and Part 11, and Day 3 on Bioanalytical Issues. Debi Garvin, MS RQAPGLP will facilitate Day 1, while Monica Cahilly MS RQAP-GLP will instruct Day 2 and Dr. Chris Tudan will provide his technical and regulatory expertise for Day 3. Attendees can sign up for 1,2, or 3 days. All three instructors provide a practical approach to dealing with compliance issues while keeping the session interactive and informative. Of critical importance on days 2 and 3 will be compliance issues with electronic data and agency expectations. With the agency renewed inspection focus on Part 11 and regulatory compliance directives to audit the electronic version of raw data, it is critical that scientists, supervisors and QA understand what to look for and where issues may occur. Monica Cahilly is a well-regarded expert in the field of validation and electronic data capture issues. Perhaps the fastest moving target in regulatory compliance is in the bioanalytical arena. There is a huge move towards globalization of bioanalytical requirements, with increased attention being paid to biomarkers and ligand binding assays in addition to traditional small molecule assays. Dr. Chris Tudan is a well-known regulatory expert on bioanalytical issues and is leading the SQA efforts (through BASS) on the globalization process. He will also be presenting excerpts from the Bioanalytical meeting held last April in Montreal.