COURSE ID 2136

GLP Study Director

How to deal with GLP, Sponsors, QA, and multi-site challenges

AVAILABLE ON-DEMAND
Duration: 8 Hours
Course Instructor

David Long

Price
$ 2052
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Benjamin Franklin famously said: “Tell me and I forget, teach me and I may remember, involve me and I learn.”

This intensive accredited course has been entirely redesigned with Franklin’s cogent observation in mind so that each person can get involved in problem-solving and thus learn about how to run regulatory studies that must be performed in compliance with Good Laboratory Practice (GLP) Regulations.

Overall, the main intent is to review the roles and responsibilities of the STUDY DIRECTOR who is in overall control when running GLP studies. The learning initiative is achieved through short lectures, illustrative answers to FAQs, and by collective problem-solving workshops. The aim is to ensure that each participant is personally faced with real-life situations for which a study director has to find GLP-compliant solutions.

To understand GLP study direction you must understand how studies are planned, performed, and reported. The course also includes workshops on protocols (study plans), the implementation of procedures, and the importance of the study report within the context of the GLP safety studies.

At every research laboratory, GLP study directors inevitably have problems of GLP implementation. The participants will be challenged to give their own reactions to real-life situations and to solve the issues arising in a way compliant with the regulations.

Involving the participants in GLP decision-making processes means that they will learn and understand rather than just receiving information as they would from a standard course.

This accredited training will concentrate on existing OECD and FDA Good Laboratory Practices and their application to the workplace including recent developments such as multi-site studies.

Upon completion of this course, you will be able to:

  • Evaluate risks to study integrity, and develop strategies for dealing with these issues.
  • Perform preclinical studies to full GLP compliance.
  • Respond appropriately to Quality Assurance and Monitoring inspectors.
  • Build adequate communication channels with the aim of successfully dealing with the multi‐site situation.
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The course is designed for people who are considering a career opportunity in GLP study direction or those who are already GLP study directors and wish to refresh or perfect their knowledge about running studies in compliance with GLP.

The course will benefit the following individuals:

  • Existing Study Directors who wish to upgrade their competence in a multi-site situation
  • The newly appointed Study Director
  • Study Supervisors who wish to become Study Directors
  • Study Monitors
  • Principal Investigators in the field of Preclinical Regulatory R&D
  • Coordinators of multi-site projects

Course Instructor

David Long

Long and Associates International Consulting Ltd.

David Long’s Courses

Accreditation

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

Learn more

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