GLP Training

QAI trainers have conducted several hundred GLP training seminars in numerous settings.  These included:

  • Training in EPA GLP of one University Professor and four Researchers in his research laboratory to allow the conduct of three studies over a three-year period with the Professor as Study Director.  This multi-site study included other test sites, three of which did not typically operate in a GLP environment.  Each site was trained in the GLP before performing the specific phase of the study that it conducted.  University personnel, as well as personnel at sites that participated in the study for more than one calendar year, were given refresher training at an appropriate time.  All participants successfully applied this training during the conduct of the studies, which were accepted by EPA.
  • Training in FDA GLP of over 100 sponsor laboratory personnel of this pharmaceutical company.  The training was so successfully received that the trainer was requested to return a few years later to repeat this performance.
  • Training in FDA GLP of contract analytical laboratory personnel.  Training included discussions of the differences between FDA GLP, EPA GLP, and OECD GLP, of the Mutual Acceptance of Data, of applicable requirements of the Good Clinical Practice and of HIPAA.
  • Yearly FDA GLP training of students of the Pharmacology Department in this University that performs safety studies on animals.  The training allows these students to perform all necessary technical procedures in the studies that are subsequently submitted to FDA in individual INDs.  The GLP training, and the support in the implementation of the GLP in this Department, were so successful that the Department of Cardiology of the same University has QAI train their staff in the FDA GLP as well.
  • Presented and discussed the OECD GLP Consensus documents on Study Director and Multi-Site studies, as they related to a research unit of a multinational pharmaceutical drug company.  The compatibility of FDA GLPs with other countries GLP regulations, such as Japan’s, were addressed in the context of performing these multi-site studies across international boundaries.
  • Conducted the first EPA GLP training of all scientific personnel in this small venture-capital laboratory.   The training continued with specific training of personnel who were designated as study director for specific studies, discussing the OECD GLP Consensus document on Study Director and its implications in the leadership of these studies.  Upper management of the company were then trained in the specific expectations of Sponsors of GLP studies, discussing the OECD GLP Consensus documents on Sponsors.  The laboratory personnel subsequently conducted a series of GLP studies documenting the efficacy of this antimicrobial pesticide used as a sterilant. These studies were then submitted to EPA in the support of the registration of this sterilant.
  • Training in EPA GLP of the personnel in an analytical contract laboratory focused the discussions more extensively on the qualification (IQ, OQ, and PQ), maintenance, and calibration of the analytical equipment.  Discussions included the use of characterized analytical standards to assure the traceability of the measurements.
  • Training in FDA GLP of the personnel in a bioanalytical contract laboratory  outlined the general GLP requirements applicable to the work performed at this site.  This training was followed by a gap analysis of the work performed at the laboratory, identifying areas requiring corrective actions, and relating these to the GLP requirements discussed in the training.