QACV Consulting Senior Compliance Consultant (GLP) Angela Haan presented “From From non-GLP to GLP, Lessons Learned” for MWSQA in June.
Title: From non-GLP to GLP, Lessons Learned
University and non-GLP research laboratories expanding to conduct GLP studies have the groundwork for sound research, but organizational and procedural changes are needed to ensure full regulatory compliance. Adequate study oversight and finding a GLP resource are critical to the foundation needed to execute a successful GLP program. GLP compliance of preclinical research is important to ensure that a study is accepted by the FDA and the continuation of the drug development program. This presentation will focus on case studies and compliance “lessons learned” from the first GLP study/ies conducted at two small preclinical laboratories over the past 1-2 years. Topics related to document control, equipment management, and good documentation practice are discussed. As well as the relevance and importance to GLP compliance and beyond compliance such as auditing and soft skills.