Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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 Good Clinical Practices regulations pertain to studies utilizing human subjects or clinical studies. While the GLPs do not specificall 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 articl, adherence to their principles will further ensure the accuracy of any results achieved. And the GMPs pertain to the manufacture of product to be used in trials and then in release to the field / public.
This webinar will define what are the US FDA's expectation for proper laboratory / clinical / manufacturing 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 these 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 repeatibility / reproducibility of lab results. There will be a detailed analysis of the applicalbe regulations for industry. Subject areas considered are: