GLP Training for Study Directors – October , 2009



RoseTECH Consulting, Inc.

GLP Training for Study Directors

One-Day Workshop

Instructor – Celeste Rose, RQAP-GLP

October 29, 2009 Cleveland, Ohio

Attendance will be limited.

This workshop is a small group interactive training event designed to provide attendees with a sound understanding of GLPs. It goes beyond a reiteration of the regulations and delves into the fundamental principles and practices of Good Laboratory Practices. Examples are incorporated throughout the workshop to demonstrate how the GLP standards and principles are put into action dealing with real-life trials and tribulations which are encountered in non-clinical lab studies.

Participants will gain 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.

This session will cover study compliance and the importance of good documentation, effective writing, and most importantly study reconstructibility. 

Agenda (full description on next page)

• GLP Roles and Responsibilities of Study Directors

• Study Conduct – Embracing the GLP Mindset

• Good Documentation and Study Reconstructibility

• Effective Writing of Protocols, Amendments, Deviations, and Study Reports

• Workshop Exercises and Q&A

Who Should Attend:

• Study Directors and Principal Investigators

• Study Personnel who may become Study Directors or Principal investigators

• Managers/QA professionals, who wish to gain an increased understanding of Study Director role & GLP responsibilities

Course Objectives:

• Gain a greater understanding of GLP regulations that apply to GLP roles and responsibilities

• Locate citations pertaining to specific GLP requirements

• Learn how to effectively and compliantly execute quality GLP studies

• Generate quality, compliant study protocols, study file documentation, reports

• Apply newly learned skills and knowledge to problem-solving, mitigation, and prevention

RoseTECH Consulting, Inc.

GLP Training for Study Directors One-Day Workshop

Instructor – Celeste Rose, RQAP-GLP

October 29, 2009 Cleveland, Ohio

Attendance will be limited.

Workshop Content

GLP Roles and Responsibilities of Study Directors

Overview of FDA/EPA/ and OECD Good Laboratory Practice Standards with a focus on the regulatory requirements and responsibilities of a GLP Study Director & Principal Investigator. In addition to technical and regulatory qualifications, several other skills important for effective study direction will be covered.

Study Conduct – Embracing the GLP Mindset

This session takes a different approach to learning and understanding the GLPs. There are basically six fundamental principles of GLP – Control/Accountability; Clear Study Design/Objectives; Prevention of Contamination, Mix-up or Deterioration; Data Quality & Integrity; Accurate Results/Conclusions; and ultimately RECONSTRUCTIBILITY. Acknowledgement of the premises of GLPs fundamental principles lays the foundation to allow us to incorporate GLPs instinctively into our everyday functions.

Good 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.

Effective Writing of Protocols, Amendments, Deviations, and Study Reports

Clear, concise writing is a key to study reconstructibility. This section will cover protocol, protocol amendment, and report writing and effective documentation of deviations and unexpected circumstances, with a focus on writing for the “reader”. This will include technical writing helpful hints and report organization skills to produce well-written documents.

Workshop Exercises and Q&A

Workshop exercises will be presented to challenge the participant to apply newly learned knowledge of the principles of GLP. FDA Warning Letter and 483 Findings will be presented throughout the workshop.

RoseTECH Consulting, Inc.

GLP Training for Study Directors One-Day Workshop

Instructor – Celeste Rose, RQAP-GLP

October 29, 2009 Cleveland, Ohio

8:00 – 4:00 p.m.

$500/attendee - includes continental breakfast, lunch, breaks, and workshop materials.

Print this form and send by mail, e-mail (pdf), or fax with payment.

Participant’s Name:     

Title:     

Company:     

Adress:     

City/State/Zip:     

Phone:       Email:     

Study Director

New Study Director ( ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download