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.
