PTI - international

Course Description

A critical part of keeping pace with modern manufacturing practices is ensuring the quality of your finished product, and thereby limiting the amount of recalls, returns, and defects.  But how is the best accomplished while maintaing GMP compliance? FDA recently issued a guidance intended to facilitate the implementation of a modern quality systems and risk managment approach to pharmaceutical manufactuing in order to maintain GMP regulatory compliance.  Manufacturers implementing a quality systems approach can benefit from fewer FDA inspections so proper training is curical.  This course will cover each component of a Quality System, including managment responsibilities, resources, manufacturing, and evaluation activities.  Additionally, each of the five manufacturing systems will be reviewed and participants will learn best practices for ensuring that they create an interconnected and compliant quality system through exercises and case studies.  Strategies for effective documentation practices, proper change control activities, validation protocols, and corrective actions will be addressed.  Participants will also learn methods for conducting internal audits to evaluate quality and examine lessions learned by the medical device industry's QSIT inspection.  This course will also provide specific details on how Process Analytical Technology (PAT) is being applied as a way to implement the quality systems approach.