Good Manufacturing Practice (GMP) Training

Overview
This course is based on the official GMP guidelines and is a complete training solution for all individuals that need to acquire Good Manufacturing Practice knowledge for medicinal products for human use. This course provides an introduction to GMP for pharmaceuticals and the current U.S. FDA regulations. It reviews a brief history of GMP regulations and discusses the regulatory requirements for the quality management system, equipment, batch records, validation, packaging, labeling, holding, distribution, and audits.

Course Outlines
• GMP History & Trends
• GMP in the US

• Basic principles of GMP
– Personnel
– Hygiene
– Premises / Production
– Documentation
– Risk management
– Qualification / Validation
– Communication with clients/authorities

• Elements of Quality Management System
– Change Control
– Deviations
– CAPA (Corrective Actions – Preventive Actions)
– Failure Investigations
– OOS (Out of Specification)
– Audits – Inspections
– Falsified products

Who Should Attend
Distribution Staff, Labeling Staff, Other sponsor organization representatives that contract to GMP vendors and need to understand the regulations., Packaging Staff, Production and Manufacturing Technicians, Quality Professionals, Validation Staff`

Course Outcomes
By the end of the course you will:
• Be able to find your way confidently around the rules and guidelines of GMP
• Be able to find your way confidently around the UK ‘Orange Guide’, (which incorporates the EU Guide to GMP)
• Be able to find your way confidently around the FDA Code of Federal Regulations
• Have acquired a broad but comprehensive knowledge of GMP allowing you to speak and act with confidence in your work environment
• Have developed an understanding of the current GMP expectations and how to interpret and apply them in practical situations