PTI - international

Course Description

As the FDA continues to revise and finalize draft guidances regarding Labeling and Packaging, it is now more important then ever to be up to date on the regulations and the newest techniques to comply with them.  This course will provide participants with the skills and knowledge necessary to comply with the FDA's regulatory requirements and avoid enforcement actions.  By examining GMP and USP requirements, and readying your site for an FDA inspection, those attending will return to work with a comprehensive knowledge of labeling and packaging processes.  Throughout the course, participants will be able to examine actual products to see how the entire process comes together. Day one will begin with an overview of key issues and a description of who is responsible for what in the development of labeling and packaging, as well as learning how to write SOPs for labeling and packaging processes. On Day two, topics include: reducing medical errors; legibility and understandability of labeling; legal issues related to repackaging and relabeling; and the FDA's new bar code requirements.  By the end of the training course, participants will be armed with numerous strategies to avoid recalls, prevent drug product counterfeiting and tampering, and improve patient safety.