Who Should Attend
This advanced course is designed for Quality Assurance personnel, or managers wishing to know more about how best to implement and audit GLP in their facilities. As the course explores issues innovative to the GLP arena, it provides an opportunity for experienced personnel to update their competencies. Participants may come from:
• Industry
• Academia
• Government
• Contract Testing Facilities
Description
This course will explore the activities of a Quality Assurance department when auditing studies 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 in-life phases and the audit of final reports. The presenters will consider how an effective rationale can be developed to provide a solid basis for the implementation of a QA audit & inspection program. Consideration will be given to the auditing of suppliers and subcontractors and the role of QA vis-à-vis computer 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 the GLP text. 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.
Lectures will be supplemented with many interactive case studies, problem solving experiences and workshops. Emphasis will be on the options available for meeting regulatory requirements.
