It seems that every year our profession is presented, by our EPA and FDA compliance inspectors, with data which informs us about 1) the number and types of facilities inspected, and 2) what kinds of compliance issues were observed during these inspections. More often than not the issues observed are the same each year. Examples include lack of a QAU, lack of proper protocol objectives, raw data not accurately recorded as per GLPS, and Study Director and Management not grasping the depth and detail of the GLP Standard requirements. My presentation will include the following: GLP Compliance Issues, Two Stories to Ponder, Achieving compliance, Conclusions/Discussions.

Failure to comply: How does this happen?

2019 Fall National Meeting

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.