Course Description

GLP Study Director

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Course ID 2136

In-Person Course

Who Should Attend?
This course is designed for those who already have some experience in managing GLP studies; those who wish to extend their role to study direction and their competence in study management, particularly in the complex multi-site environment. 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 Description
The current regulatory environment imposes far reaching responsibilities on Study Directors and Principal Investigators in preclinical regulatory R&D. This course takes as reference the GLP regulations of the FDA and OECD and the associated OECD interpretive monographs particularly on study direction, sponsor responsibilities and multi-site studies.

Dealing with the increased range of duties and responsibilities of study managers is the core issue of this course.

The course goes further than presenting the theoretical roles of study managers in the difficult arena of multi-site studies. The workshop based activities address the practical aspects of study direction and investigate possible solutions to ensure full compliance.

A strong feature of this course is the high level of interactive, dynamic problem solving situations that the participants are asked to resolve appropriately and speedily. The strategies available for managing compliant studies are given topmost priority.

The presenter recognizes that many courses can provide information, but information can only be turned into knowledge through the depth of understanding that comes from sharing experience and exchanging ideas. This is why a workshop approach is so valuable.

Maximize Your Learning!
Attend this course and its Companion Courses:
Good Laboratory Practices (GLP)
September 26-28, 2018 • New Brunswick, NJ • Course ID #545

GLP and Quality Assurance: Developing a GLP Compliant QA Program
October 1-2, 2018 • New Brunswick, NJ • Course ID #2564

Course Director
Philip Withers, GLP training and compliance consultant

Philip Withers was Director of Quality Assurance at MDS Pharma Services in France and has been involved in preclinical QA for over 35 years. For 25 years he worked in non-clinical contract laboratories in England and France where he set up the quality assurance programme worldwide. Mr. Withers is a member of the organising committee of SoFAQ (the French national QA society), past chairman of the multi-site working party and senior editor of the Quality Assurance Journal. He has presented many papers at international QA meetings and has been involved for several years in developing a variety of training programmes nationally and internationally including OECD training workshops.

Fourteen years ago he created his own GLP training and compliance consultancy.

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