Description
What is inside this course?
The course introduces you to the regulatory requirements of the Licence Holder as defined by UK Human Medicines Regulations (2012) (as amended) (HMR) and EU Good Distribution Practice (GDP) guidelines. Each chapter of the EU GDP Guidelines are introduced subject by subject. The requirements and ramifications that you – the Licence Holder – are subject to are explained clearly.
Who is it for?
This course is for Wholesale Distribution Authorisation (WDA) Licence Holders or those who act as a representative to the Licence Holder within a licensed GDP wholesale and distribution setting.
What will I learn?
You will become familiar with the regulations and guidelines that concern the role of Licence Holder, be able to understand what is expected of you with regards involvement with the Quality Management System and all GDP related activities, including your working relationship with your nominated Responsible Person.
