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GLP and Quality Assurance: Developing a GLP Compliant QA Program

 
  July 07, 2017  
     
 
CfPA-The Center for Professional Advancement, New Brunswick, NJ
October 26-27, 2017


Who Should Attend?
The participants in this course will already know the basics of GLP. The course is designed for those who wish to master how to implement and maintain a GLP QA function. The course explores quality issues within preclinical GLP and provides an opportunity for experienced personnel to update their competencies. Participants may come from:

  • Life-Science Industries
  • Academia
  • Government
  • Contract Testing Facilities

RAPS - Regulatory Affairs Professional Society 
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion. 

Course Description
This 2-day intensive course will explore the activities of a Quality Assurance department when auditing or inspecting studies and facilities for GLP compliance. All aspects of QA work will be discussed including; the preparation of planning documents, review of protocols and SOPs, inspection of facilities and processes, performance of inspections of on-going phases and the audit of final reports. The presenter will particularly consider the rationale to apply when developing and implementing a QA audit & inspection program. Consideration will be given to the role of QA vis-à-vis computerized systems. The reference materials will be the FDA and OECD Good Laboratory Practice Regulations and the series of monographs of the OECD relating to the interpretation of these GLP principles. Time will also be given to the setting up of quantitative techniques for the measurement of Quality, enabling participants to follow the compliance level within laboratories. Presentations will be supplemented with many interactive case studies, problem solving experiences and workshops. Emphasis will be placed on the various options available for meeting regulatory requirements.

Maximize Your Learning!
Attend this course and its Companion Course:
Good Laboratory Practices
October 23-25 2017 • New Jersey • Course ID #545
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   David Long; Long and Associates International Consulting Ltd.

David Long worked for Rhône Poulenc Health Division (now Sanofi-Aventis) in Quality Assurance (QA) for over twenty years where he gained considerable experience in all three Good Practice disciplines, GLP, GCP and GMP. When he left Rhône-Poulenc he was Senior Director R&D worldwide for Quality and for Process Improvement. Mr. Long has since worked for CHIMEX, a manufacturing subsidiary of the L’Oreal group and now runs his own consultancy company.

David Long has always shown a keen interest in promoting professional QA activities. He was a founding member and President of the French QA Society and a founding member and President of the European QA Federation. He was also the founder and Chief Editor of the Quality Assurance Journal, an international scientific journal specifically addressing subjects of interest to R&D and QA personnel.

He has lectured and trained widely and has been an active participant in developing training in Good Practices and QA, working with a number of international groups including the OECD and the WHO. His latest contribution through the WHO has been in the co-authoring of a set of guidelines for research performed upstream of the regulatory scene, called “Quality Practices in Basic Biomedical Research”.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
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