Introduction to GMP and Quality Systems
GMP is short for Good Manufacturing Practice and is commonly used also for Quality Management systems related to manufacture of medicinal products/pharmaceuticals. Other organisations within the Life Science industry, e.g. developers of IVDs and Medical Devices have to follow similar requirements. In this introductory course, you will get an overview of the requirements and guidelines that governs quality management related to manufacturing. The course is based on requirements for pharmaceuticals but regulatory requirements and ISO 13485 for medical device quality systems is briefly covered.
Learning objectives
- Understand and define different terms used and being able to navigate in applicable regulatory texts and guidance from authorities
- Get additional knowledge in the specific GMP requirements related to manufacture of pharmaceuticals and medical devices/IVDs
- Be familiar with the most common terms and the general methodology for qualification and validation
- Be familiar with the basic requirements related to instructions and records, regardless of if they are in paper or electronic form to ensure data integrity
No pre-requisites