PTI - international

Course Description

Good Manufacturing Practices (GMPs) are regulations that describe the methods, equipment, facilities, and controls required for producing safe and effective pharmaceutical and biotech products. Non-compliance with GMPs can be expensive, time-consuming and can result in FDA regulatory action levied against your firm. This introductory-level training course presents an overview of the framework and principles of GMPs. The program begins by reviewing the background and history of GMPs and defining roles and responsibilities of those affected by the requirements. Learn how to design a GMP-compliant system and evaluate proven strategies for implementing GMPs to prepare for an FDA inspection of your facility. The course addresses how best to comply with requirements governing component control, warehousing, storage and distribution operations. By the end of day two, participants will be able to implement proven validation solutions and identify current regulatory enforcement trends. An emphasis is placed on achieving behavioral change of participants through the use of hands-on learning tools and exercises. Don't miss the most interactive and thorough GMP training course!