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Pacific Rim Consulting, Inc. - NEWSLETTER

Volume 14 Issue 1 - Page 2 - Winter/Spring 2012

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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
This two day seminar focuses on criteria and responsibilities when serving as a Study Director or Study Monitor conducting/monitoring studies under FDA/EPA and/or OECD GLPs. The course is also valuable for Facility Management and many Principal Investigators. Key elements of the course include Study Director/Monitor responsibilities; use and content of SOPs; monitoring in-house, contract, and multi-site studies; and interactions with QA, Investigators, and other study personnel. Additional focus is on the actual conduct and monitoring of studies including protocol development, use of SSPs, pre-study planning, study conduct, technical review of data, writing final reports, and archiving. Who should attend – new study directors, study directors needing refresher or additional training, sponsor monitors, managers, and quality assurance personnel who routinely interact with study directors. NOTE: This course has been modified and reduced to two days. It no longer includes basic GLP requirements. For any study director who has not had at least 3 years GLP experience, GLPs 101 is essential.

GLPs – Black, White and Grey (new!)

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. Although there are several “black and white” areas of the GLPs, most provisions of the regulations fall into the “grey areas” and associated industry standards (e.g. what is adequate calibration/verification). 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, along with current industry standards. 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 CD with essential background reading and reference material is provided.

West Coast Quality Training Institute

2009 Training Schedule

Hood River, OR

More Information

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.

Quality Assurance Audits and Inspections

Quality Assurance is mandated by the Good Laboratory Practice Regulations (GLPs) to help assure the quality and integrity of studies submitted to regulatory agencies. Personnel involved with providing Quality Assurance oversight of GLP regulated studies must understand their roles and responsibilities, which go beyond traditional quality control and quality assurance functions. This two-day seminar focuses on the practical applications of GLPs based on interpretive documents, industry standards, sound scientific principles, common sense and current regulations. Due to the “one size fits all” approach of the GLPs, “special considerations” sessions involving field sites, analytical laboratories and toxicology have been developed which stress critical issues in each of these arenas. This course is also recommended for facility and study managers wanting to assess the effectiveness of their QA.

GLP TRIPLE PLAY - PENDING

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 RQAP-GLP 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 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.