Faculty: John E. Lincoln
This webinar is intended to provide guidance regarding Good Laboratory Practices (GLP) for use in pharmaceutical manufacturing and clinical trials, and for use by contract laboratories that support the regulated medical products industries.
The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products. The regulations do not pertain to studies utilizing human subjects or clinical studies for which the current Good Clinical Practice (cGCP) standards would apply, although they support the GCPs. While the GLPs do not specifically pertain to basic exploratory studies carried out to determine whether a test article has any potential utility or, for FDA studies only, to determine physical or chemical characteristics of a test article, adherence to their principles will further ensure the accuracy of any results achieved.
Areas Covered in the Session :
This webinar will define what are the US FDA’s expectation for proper laboratory practices, systems, equipment usage, and documentation / record-keeping. It will evaluate the requirements for how basic Quality Management System (QMS) expectations / requirements are addressed in the lab environment. The webinar with evaluate pharma GMPs and 21 CFR 58 and associated regulations to see how the GLP’s can be implemented in the real world to achieve FDA requirements and ensure the accuracy and repeatability / reproducibility of lab results. There will be a detailed analysis of the applicable regulations for industry. Subject areas considered are:
Who Should Attend: