2nd Good Laboratory Practice Compliance Monitoring Summit from January 26-27, 2017
Good Laboratory Practice (GLP) is a data quality system in place to ensure the uniformity, consistency, reliability and reproducibility of preclinical studies in laboratories and organizations conducting research. Prior to clinical trials (where laboratories and pharmaceutical companies are subject to Good Clinical Practice (GCP)), non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported according to GLP regulations. While there is no specific certification or accreditation issued by a regulatory body in the United States, laboratories are subject to an FDA audit if a study looks to not be compliant with GLP.
GLP regulations were created in response to a lack of consistency and quality in the conduct of studies performed to assess the safety of chemicals that humans might be exposed to, as well as the safety of drugs prior to initiation of first-in-human studies. During the 1970s, severe deficiencies in the conduct of nonclinical toxicological studies were uncovered in many labs — the most notable and egregious example being the Industrial Bio-Test Laboratories scandal. In this case, 71 percent of studies audited by the FDA were invalidated for falsified or incorrectly gathered data. In particular, evidence of toxicity results were covered up by changing results. To ensure that this type of laboratory misconduct would not occur again, GLP regulations were adopted by the FDA and made law on June 20, 1979.
Laboratories need to uphold Good Laboratory Practice (GLP) that state that operating procedures — from materials handling to sample testing and documentation — are upheld to the standards dictated by regulatory authorities. This can be a very costly and time-consuming effort; one in which meticulous attention to detail and metrics are required in order to guarantee a successful inspection. Having a guide through the GLP-overhaul to edit procedures, retrain staff and update infrastructure is vital to passing an audit.
Top Five Reasons to Attend
- Learn how to prepare your laboratory for an FDA GLP audit
- Understand the differences between the FDA and EPA’s interpretation and execution of Good Laboratory Practice
- Network with leading regulatory, quality and laboratory professionals
- Discuss industry, operational and technical challenges facing Good Laboratory Practice
- Learn about maintaining quality standards for employees, infrastructure and testing
Who Should Attend
This conference is designed for representatives from pharmaceutical, medical device and biotechnology companies, as well as laboratories with responsibilities in the following areas:
This conference is also of interest to: